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Provide a summary and key takeaways from the given text.
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This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability
for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official
Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links
embedded in this document
►B REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and
Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
(Text with EEA relevance)
(OJ L 117, 5.5.2017, p. 1)
Amended by:
Official Journal
No page date
►M1 Regulation (EU) 2020/561 of the European Parliament and of the
Council of 23 April 2020 L 130 1 8 24.4.2020
►M2 Commission Delegated Regulation (EU) 2023/502 of 1 December 20 22 L 7 0 1 8.3.2023
►M3 Regulation (EU) 2023/607 of the European Parliament and of the
Council of 15 March 2023 L 80 2 4 20.3.2023
►M4 Regulation (EU) 2024/568 of the European Parliament and of the
Council of 7 February 2024 L 568 1 14.2.2024
►M5 Regulation (EU) 2024/1860 of the European Parliament and of th e
Council of 13 June 2024 L 1860 1 9.7.2024
Corrected by:
►C1 Corrigendum, OJ L 117, 3.5.2019, p. 9 (2017/745)
►C2 Corrigendum, OJ L 334, 27.12.2019, p. 165 (2017/745) 02017R0745 — EN — 10.01.2025 — 005.001 — 1
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Summary: This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability
for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official
Journal of the European Union and available...
|
Summarize the content of the article and explain its significance in medical device regulation.
|
02017R0745 — EN — 10.01.2025 — 005.001 — 2
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC)
No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council
Directives 90/385/EEC and 93/42/EEC
(Text with EEA relevance)
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1. This Regulation lays down rules concerning the placing on th e
market, making available on the market or putting into service of
medical devices for human use and accessories for such devices in
the Union. This Regulation also applies to clinical investigati ons
concerning such medical devices and accessories conducted in th e
Union.
2. This Regulation shall also apply, as from the date of applic ation of
common specifications adopted pursuant to Article 9, to the gro ups of
products without an intended medical purpose that are listed in
Annex XVI, taking into account the state of the art, and in par ticular
existing harmonised standards for analogous devices with a medi cal
purpose, based on similar technology. The common specifications for
each of the groups of products listed in Annex XVI shall addres s, at
least, application of risk management as set out in Annex I for the
group of products in question and, where necessary, clinical ev aluation
regarding safety.
The necessary common specifications shall be adopted by
►M1 26 May 2021 ◄. They shall apply as from six months after
the date of their entry into force or from ►M1 26 May 2021 ◄,
whichever is the latest.
Notwithstanding Article 122, Member States' measures regarding the
qualification of the products covered by Annex XVI as medical
devices pursuant to Directive 93/42/EEC shall remain valid unti l the
date of application, as referred to in the first subparagraph, of the
relevant common specifications for that group of products.
This Regulation also applies to clinical investigations conduct ed in the
Union concerning the products referred to in the first subparag raph.
3. Devices with both a medical and a non-medical intended purpo se
shall fulfil cumulatively the requirements applicable to device s with an
intended medical purpose and those applicable to devices withou t an
intended medical purpose.
4. For the purposes of this Regulation, medical devices, access ories
for medical devices, and products listed in Annex XVI to which this
Regulation applies pursuant to paragraph 2 shall hereinafter be referred
to as ‘devices’. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 2
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
of 5 April 2017
on medical devices, amending Directive 2001/83/EC, Regulation (EC)
No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council
Directives 90/385/EEC and 9...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 3
5. Where justified on account of the similarity between a devic e with
an intended medical purpose placed on the market and a product
without an intended medical purpose in respect of their charact eristics
and risks, the Commission is empowered to adopt delegated acts in
accordance with Article 115 to amend the list in Annex XVI, by
adding new groups of products, in order to protect the health a nd
safety of users or other persons or other aspects of public hea lth.
6. This Regulation does not apply to:
(a) in vitro diagnostic medical devices covered by Regu
lation (EU) 2017/746;
(b) medicinal products as defined in point 2 of Article 1 of
Directive 2001/83/EC. In deciding whether a product falls under
Directive 2001/83/EC or under this Regulation, particular accou nt
shall be taken of the principal mode of action of the product;
(c) advanced therapy medicinal products covered by Regu
lation (EC) No 1394/2007;
(d) human blood, blood products, plasma or blood cells of human
origin or devices which incorporate, when placed on the market
or put into service, such blood products, plasma or cells, exce pt
for devices referred to in paragraph 8 of this Article;
(e) cosmetic products covered by Regulation (EC) No 1223/2009;
(f) transplants, tissues or cells of animal origin, or their de rivatives, or
products containing or consisting of them; however this Regulat ion
does apply to devices manufactured utilising tissues or cells o f
animal origin, or their derivatives, which are non-viable or ar e
rendered non-viable;
(g) transplants, tissues or cells of human origin, or their der ivatives,
covered by Directive 2004/23/EC, or products containing or
consisting of them; however this Regulation does apply to devic es
manufactured utilising derivatives of tissues or cells of human
origin which are non-viable or are rendered non-viable;
(h) products, other than those referred to in points (d), (f) a nd (g), that
contain or consist of viable biological material or viable orga nisms,
including living micro-organisms, bacteria, fungi or viruses in order
to achieve or support the intended purpose of the product;
(i) food covered by Regulation (EC) No 178/2002.
7. Any device which, when placed on the market or put into serv ice,
incorporates as an integral part an in vitro diagnostic medical device as
defined in point 2 of Article 2 of Regulation (EU) 2017/746, sh all be
governed by this Regulation. The requirements of Regu
lation (EU) 2017/746 shall apply to the in vitro diagnostic medical
device part of the device. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 3
5. Where justified on account of the similarity between a devic e with
an intended medical purpose placed on the market and a product
without an intended medical purpose in respect of their charact eristics
and risks, the Commission is empowered to ado...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 4
8. Any device which, when placed on the market or put into serv ice,
incorporates, as an integral part, a substance which, if used s eparately,
would be considered to be a medicinal product as defined in poi nt 2 of
Article 1 of Directive 2001/83/EC, including a medicinal produc t
derived from human blood or human plasma as defined in point 10
of Article 1 of that Directive, and that has an action ancillar y to that
of the device, shall be assessed and authorised in accordance w ith this
Regulation.
However, if the action of that substance is principal and not a ncillary to
that of the device, the integral product shall be governed by
Directive 2001/83/EC or Regulation (EC) No 726/2004 of the
European Parliament and of the Council ( 1 ), as applicable. In that
case, the relevant general safety and performance requirements set out
in Annex I to this Regulation shall apply as far as the safety and
performance of the device part are concerned.
9. Any device which is intended to administer a medicinal produ ct as
defined in point 2 of Article 1 of Directive 2001/83/EC shall b e
governed by this Regulation, without prejudice to the provision s of
that Directive and of Regulation (EC) No 726/2004 with regard t o
the medicinal product.
However, if the device intended to administer a medicinal produ ct and
the medicinal product are placed on the market in such a way th at they
form a single integral product which is intended exclusively fo r use in
the given combination and which is not reusable, that single in tegral
product shall be governed by Directive 2001/83/EC or Regu
lation (EC) No 726/2004, as applicable. In that case, the relev ant
general safety and performance requirements set out in Annex I to
this Regulation shall apply as far as the safety and performanc e of
the device part of the single integral product are concerned.
10. Any device which, when placed on the market or put into
service, incorporates, as an integral part, non-viable tissues or cells of
human origin or their derivatives that have an action ancillary to that of
the device shall be assessed and authorised in accordance with this
Regulation. In that case, the provisions for donation, procurem ent and
testing laid down in Directive 2004/23/EC shall apply.
However, if the action of those tissues or cells or their deriv atives is
principal and not ancillary to that of the device and the produ ct is not
governed by Regulation (EC) No 1394/2007, the product shall be
governed by Directive 2004/23/EC. In that case, the relevant ge neral
safety and performance requirements set out in Annex I to this Regu
lation shall apply as far as the safety and performance of the device part
are concerned.
11. This Regulation is specific Union legislation within the me aning
of Article 2(3) of Directive 2014/30/EU. ▼B
( 1 ) Regulation (EC) No 726/2004 of the European Parliament and of the Council
of 31 March 2004 laying down Community procedures for the autho risation
and supervision of medicinal products for human and veterinary use and
establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 4
8. Any device which, when placed on the market or put into serv ice,
incorporates, as an integral part, a substance which, if used s eparately,
would be considered to be a medicinal product as defined in poi nt 2 of
Article 1 of Directive 2001/83/EC, i...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 5
12. Devices that are also machinery within the meaning of point (a)
of the second paragraph of Article 2 of Directive 2006/42/EC of the
European Parliament and of the Council ( 1 ) shall, where a hazard
relevant under that Directive exists, also meet the essential h ealth and
safety requirements set out in Annex I to that Directive to the extent to
which those requirements are more specific than the general saf ety and
performance requirements set out in Chapter II of Annex I to th is
Regulation.
13. This Regulation shall not affect the application of
Directive 2013/59/Euratom.
14. This Regulation shall not affect the right of a Member Stat e to
restrict the use of any specific type of device in relation to aspects not
covered by this Regulation.
15. This Regulation shall not affect national law concerning th e
organisation, delivery or financing of health services and medi cal
care, such as the requirement that certain devices may only be
supplied on a medical prescription, the requirement that only c ertain
health professionals or healthcare institutions may dispense or use
certain devices or that their use be accompanied by specific pr ofessional
counselling.
16. Nothing in this Regulation shall restrict the freedom of th e press
or the freedom of expression in the media in so far as those fr eedoms
are guaranteed in the Union and in the Member States, in partic ular
under Article 11 of the Charter of Fundamental Rights of the Eu ropean
Union.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘medical device’ means any instrument, apparatus, appliance ,
software, implant, reagent, material or other article intended by
the manufacturer to be used, alone or in combination, for human
beings for one or more of the following specific medical purpos es:
— diagnosis, prevention, monitoring, prediction, prognosis,
treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compen
sation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of
a physiological or pathological process or state,
— providing information by means of in vitro examination of
specimens derived from the human body, including organ,
blood and tissue donations, ▼B
( 1 ) Directive 2006/42/EC of the European Parliament and of the Co uncil of
17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157,
9.6.2006, p. 24).
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 5
12. Devices that are also machinery within the meaning of point (a)
of the second paragraph of Article 2 of Directive 2006/42/EC of the
European Parliament and of the Council ( 1 ) shall, where a hazard
relevant under that Directive exists, also mee...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 6
and which does not achieve its principal intended action by pha r
macological, immunological or metabolic means, in or on the
human body, but which may be assisted in its function by such
means.
The following products shall also be deemed to be medical
devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or
sterilisation of devices as referred to in Article 1(4) and of
those referred to in the first paragraph of this point.
(2) ‘accessory for a medical device’ means an article which, wh ilst not
being itself a medical device, is intended by its manufacturer to be
used together with one or several particular medical device(s) to
specifically enable the medical device(s) to be used in accorda nce
with its/their intended purpose(s) or to specifically and direc tly
assist the medical functionality of the medical device(s) in te rms
of its/their intended purpose(s);
(3) ‘custom-made device’ means any device specifically made in
accordance with a written prescription of any person authorised
by national law by virtue of that person's professional qualifi
cations which gives, under that person's responsibility, specif ic
design characteristics, and is intended for the sole use of a
particular patient exclusively to meet their individual conditi ons
and needs.
However, mass-produced devices which need to be adapted to
meet the specific requirements of any professional user and
devices which are mass-produced by means of industrial manu
facturing processes in accordance with the written prescription s of
any authorised person shall not be considered to be custom-made
devices;
(4) ‘active device’ means any device, the operation of which de pends
on a source of energy other than that generated by the human bo dy
for that purpose, or by gravity, and which acts by changing the
density of or converting that energy. Devices intended to trans mit
energy, substances or other elements between an active device a nd
the patient, without any significant change, shall not be deeme d to
be active devices.
Software shall also be deemed to be an active device;
(5) ‘implantable device’ means any device, including those that are
partially or wholly absorbed, which is intended:
— to be totally introduced into the human body, or
— to replace an epithelial surface or the surface of the eye,
by clinical intervention and which is intended to remain in pla ce
after the procedure. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 6
and which does not achieve its principal intended action by pha r
macological, immunological or metabolic means, in or on the
human body, but which may be assisted in its function by such
means.
The following products shall also be deemed to be medic...
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Define the key term or concept related to medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 7
Any device intended to be partially introduced into the human
body by clinical intervention and intended to remain in place
after the procedure for at least 30 days shall also be deemed t o
be an implantable device;
(6) ‘invasive device’ means any device which, in whole or in pa rt,
penetrates inside the body, either through a body orifice or th rough
the surface of the body;
(7) ‘generic device group’ means a set of devices having the sa me or
similar intended purposes or a commonality of technology
allowing them to be classified in a generic manner not reflecti ng
specific characteristics;
(8) ‘single-use device’ means a device that is intended to be u sed on
one individual during a single procedure;
(9) ‘falsified device’ means any device with a false presentati on of its
identity and/or of its source and/or its CE marking certificate s or
documents relating to CE marking procedures. This definition do es
not include unintentional non-compliance and is without prejudi ce
to infringements of intellectual property rights;
(10) ‘procedure pack’ means a combination of products packaged
together and placed on the market with the purpose of being
used for a specific medical purpose;
(11) ‘system’ means a combination of products, either packaged
together or not, which are intended to be inter-connected or
combined to achieve a specific medical purpose;
(12) ‘intended purpose’ means the use for which a device is int ended
according to the data supplied by the manufacturer on the label , in
the instructions for use or in promotional or sales materials o r
statements and as specified by the manufacturer in the clinical
evaluation;
(13) ‘label’ means the written, printed or graphic information appearing
either on the device itself, or on the packaging of each unit o r on
the packaging of multiple devices;
(14) ‘instructions for use’ means the information provided by t he manu
facturer to inform the user of a device's intended purpose and
proper use and of any precautions to be taken;
(15) ‘Unique Device Identifier’ (‘UDI’) means a series of numer ic or
alphanumeric characters that is created through internationally
accepted device identification and coding standards and that
allows unambiguous identification of specific devices on the
market;
(16) ‘non-viable’ means having no potential for metabolism or
multiplication;
(17) ‘derivative’ means a ‘non-cellular substance’ extracted fr om human
or animal tissue or cells through a manufacturing process. The
final substance used for manufacturing of the device in this ca se
does not contain any cells or tissues; ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 7
Any device intended to be partially introduced into the human
body by clinical intervention and intended to remain in place
after the procedure for at least 30 days shall also be deemed t o
be an implantable device;
(6) ‘invasive device’ means any de...
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Define the key term or concept related to medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 8
(18) ‘nanomaterial’ means a natural, incidental or manufactured
material containing particles in an unbound state or as an
aggregate or as an agglomerate and where, for 50 % or more of
the particles in the number size distribution, one or more exte rnal
dimensions is in the size range 1-100 nm;
Fullerenes, graphene flakes and single-wall carbon nanotubes wi th
one or more external dimensions below 1 nm shall also be deemed
to be nanomaterials;
(19) ‘particle’, for the purposes of the definition of nanomate rial in
point (18), means a minute piece of matter with defined physica l
boundaries;
(20) ‘agglomerate’, for the purposes of the definition of nanom aterial in
point (18), means a collection of weakly bound particles or
aggregates where the resulting external surface area is similar to
the sum of the surface areas of the individual components;
(21) ‘aggregate’, for the purposes of the definition of nanomat erial in
point (18), means a particle comprising of strongly bound or fu sed
particles;
(22) ‘performance’ means the ability of a device to achieve its intended
purpose as stated by the manufacturer;
(23) ‘risk’ means the combination of the probability of occurre nce of
harm and the severity of that harm;
(24) ‘benefit-risk determination’ means the analysis of all ass essments
of benefit and risk of possible relevance for the use of the de vice
for the intended purpose, when used in accordance with the
intended purpose given by the manufacturer;
(25) ‘compatibility’ is the ability of a device, including soft ware, when
used together with one or more other devices in accordance with
its intended purpose, to:
(a) perform without losing or compromising the ability to perfo rm
as intended, and/or
(b) integrate and/or operate without the need for modification or
adaption of any part of the combined devices, and/or
(c) be used together without conflict/interference or adverse
reaction.
(26) ‘interoperability’ is the ability of two or more devices, including
software, from the same manufacturer or from different manu
facturers, to:
(a) exchange information and use the information that has been
exchanged for the correct execution of a specified function
without changing the content of the data, and/or
(b) communicate with each other, and/or
(c) work together as intended. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 8
(18) ‘nanomaterial’ means a natural, incidental or manufactured
material containing particles in an unbound state or as an
aggregate or as an agglomerate and where, for 50 % or more of
the particles in the number size distribution, one or more exte rn...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 9
(27) ‘making available on the market’ means any supply of a dev ice,
other than an investigational device, for distribution, consump tion
or use on the Union market in the course of a commercial activi ty,
whether in return for payment or free of charge;
(28) ‘placing on the market’ means the first making available o f a
device, other than an investigational device, on the Union mark et;
(29) ‘putting into service’ means the stage at which a device, other than
an investigational device, has been made available to the final user
as being ready for use on the Union market for the first time f or its
intended purpose;
▼C1
(30) ‘manufacturer’ means a natural or legal person who manufac tures
or fully refurbishes a device or has a device designed, manu
factured or fully refurbished, and markets that device under it s
name or trade mark;
▼B
(31) ‘fully refurbishing’, for the purposes of the definition o f manu
facturer, means the complete rebuilding of a device already pla ced
on the market or put into service, or the making of a new devic e
from used devices, to bring it into conformity with this Regula tion,
combined with the assignment of a new lifetime to the refurbish ed
device;
(32) ‘authorised representative’ means any natural or legal per son estab
lished within the Union who has received and accepted a written
mandate from a manufacturer, located outside the Union, to act on
the manufacturer's behalf in relation to specified tasks with r egard
to the latter's obligations under this Regulation;
(33) ‘importer’ means any natural or legal person established w ithin the
Union that places a device from a third country on the Union
market;
(34) ‘distributor’ means any natural or legal person in the sup ply chain,
other than the manufacturer or the importer, that makes a devic e
available on the market, up until the point of putting into ser vice;
(35) ‘economic operator’ means a manufacturer, an authorised re presen
tative, an importer, a distributor or the person referred to in
Article 22(1) and 22(3);
(36) ‘health institution’ means an organisation the primary pur pose of
which is the care or treatment of patients or the promotion of
public health;
(37) ‘user’ means any healthcare professional or lay person who uses a
device;
(38) ‘lay person’ means an individual who does not have formal
education in a relevant field of healthcare or medical discipli ne;
(39) ‘reprocessing’ means a process carried out on a used devic e in
order to allow its safe reuse including cleaning, disinfection, ster
ilisation and related procedures, as well as testing and restor ing the
technical and functional safety of the used device; ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 9
(27) ‘making available on the market’ means any supply of a dev ice,
other than an investigational device, for distribution, consump tion
or use on the Union market in the course of a commercial activi ty,
whether in return for payment or free of charg...
|
Define the key term or concept related to medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 10
(40) ‘conformity assessment’ means the process demonstrating wh ether
the requirements of this Regulation relating to a device have b een
fulfilled;
(41) ‘conformity assessment body’ means a body that performs
third-party conformity assessment activities including calibrat ion,
testing, certification and inspection;
(42) ‘notified body’ means a conformity assessment body designa ted in
accordance with this Regulation;
(43) ‘CE marking of conformity’ or ‘CE marking’ means a marking by
which a manufacturer indicates that a device is in conformity w ith
the applicable requirements set out in this Regulation and othe r
applicable Union harmonisation legislation providing for its
affixing;
(44) ‘clinical evaluation’ means a systematic and planned proce ss to
continuously generate, collect, analyse and assess the clinical
data pertaining to a device in order to verify the safety and
performance, including clinical benefits, of the device when us ed
as intended by the manufacturer;
(45) ‘clinical investigation’ means any systematic investigatio n
involving one or more human subjects, undertaken to assess the
safety or performance of a device;
(46) ‘investigational device’ means a device that is assessed i n a
clinical investigation;
(47) ‘clinical investigation plan’ means a document that descri bes the
rationale, objectives, design, methodology, monitoring, statist ical
considerations, organisation and conduct of a clinical investig ation;
(48) ‘clinical data’ means information concerning safety or per formance
that is generated from the use of a device and is sourced from the
following:
— clinical investigation(s) of the device concerned,
— clinical investigation(s) or other studies reported in scient ific
literature, of a device for which equivalence to the device in
question can be demonstrated,
— reports published in peer reviewed scientific literature on o ther
clinical experience of either the device in question or a devic e
for which equivalence to the device in question can be
demonstrated,
— clinically relevant information coming from post-market
surveillance, in particular the post-market clinical follow-up;
(49) ‘sponsor’ means any individual, company, institution or or ganis
ation which takes responsibility for the initiation, for the
management and setting up of the financing of the clinical
investigation;
(50) ‘subject’ means an individual who participates in a clinic al
investigation; ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 10
(40) ‘conformity assessment’ means the process demonstrating wh ether
the requirements of this Regulation relating to a device have b een
fulfilled;
(41) ‘conformity assessment body’ means a body that performs
third-party conformity assessment activ...
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Define the key term or concept related to medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 11
(51) ‘clinical evidence’ means clinical data and clinical evalu ation
results pertaining to a device of a sufficient amount and quali ty
to allow a qualified assessment of whether the device is safe a nd
achieves the intended clinical benefit(s), when used as intende d by
the manufacturer;
(52) ‘clinical performance’ means the ability of a device, resu lting from
any direct or indirect medical effects which stem from its tech nical
or functional characteristics, including diagnostic characteris tics, to
achieve its intended purpose as claimed by the manufacturer,
thereby leading to a clinical benefit for patients, when used a s
intended by the manufacturer;
(53) ‘clinical benefit’ means the positive impact of a device o n the
health of an individual, expressed in terms of a meaningful,
measurable, patient-relevant clinical outcome(s), including
outcome(s) related to diagnosis, or a positive impact on patien t
management or public health;
(54) ‘investigator’ means an individual responsible for the con duct of a
clinical investigation at a clinical investigation site;
(55) ‘informed consent’ means a subject's free and voluntary ex pression
of his or her willingness to participate in a particular clinic al
investigation, after having been informed of all aspects of the
clinical investigation that are relevant to the subject's decis ion to
participate or, in the case of minors and of incapacitated subj ects,
an authorisation or agreement from their legally designated rep
resentative to include them in the clinical investigation;
(56) ‘ethics committee’ means an independent body established i n
a Member State in accordance with the law of that Member State
and empowered to give opinions for the purposes of this Regu
lation, taking into account the views of laypersons, in particu lar
patients or patients' organisations;
(57) ‘adverse event’ means any untoward medical occurrence, uni n
tended disease or injury or any untoward clinical signs,
including an abnormal laboratory finding, in subjects, users or
other persons, in the context of a clinical investigation, whet her
or not related to the investigational device;
(58) ‘serious adverse event’ means any adverse event that led t o any of
the following:
(a) death,
(b) serious deterioration in the health of the subject, that re sulted
in any of the following:
(i) life-threatening illness or injury,
(ii) permanent impairment of a body structure or a body
function,
(iii) hospitalisation or prolongation of patient hospitalisatio n,
(iv) medical or surgical intervention to prevent life-threateni ng
illness or injury or permanent impairment to a body
structure or a body function, ▼B
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(51) ‘clinical evidence’ means clinical data and clinical evalu ation
results pertaining to a device of a sufficient amount and quali ty
to allow a qualified assessment of whether the device is safe a nd
achieves the intended clinical benefit(s), when...
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Define the key term or concept related to medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 12
(v) chronic disease,
(c) foetal distress, foetal death or a congenital physical or m ental
impairment or birth defect;
(59) ‘device deficiency’ means any inadequacy in the identity, quality,
durability, reliability, safety or performance of an investigat ional
device, including malfunction, use errors or inadequacy in
information supplied by the manufacturer;
(60) ‘post-market surveillance’ means all activities carried ou t by manu
facturers in cooperation with other economic operators to insti tute
and keep up to date a systematic procedure to proactively colle ct
and review experience gained from devices they place on the
market, make available on the market or put into service for th e
purpose of identifying any need to immediately apply any
necessary corrective or preventive actions;
(61) ‘market surveillance’ means the activities carried out and measures
taken by competent authorities to check and ensure that devices
comply with the requirements set out in the relevant Union
harmonisation legislation and do not endanger health, safety or
any other aspect of public interest protection;
(62) ‘recall’ means any measure aimed at achieving the return o f a
device that has already been made available to the end user;
(63) ‘withdrawal’ means any measure aimed at preventing a devic e in
the supply chain from being further made available on the marke t;
(64) ‘incident’ means any malfunction or deterioration in the c haracte
ristics or performance of a device made available on the market ,
including use-error due to ergonomic features, as well as any
inadequacy in the information supplied by the manufacturer and
any undesirable side-effect;
(65) ‘serious incident’ means any incident that directly or ind irectly led,
might have led or might lead to any of the following:
(a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patie nt's,
user's or other person's state of health,
(c) a serious public health threat;
(66) ‘serious public health threat’ means an event which could result in
imminent risk of death, serious deterioration in a person's sta te of
health, or serious illness, that may require prompt remedial ac tion,
and that may cause significant morbidity or mortality in humans ,
or that is unusual or unexpected for the given place and time;
(67) ‘corrective action’ means action taken to eliminate the ca use of a
potential or actual non-conformity or other undesirable situati on; ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 12
(v) chronic disease,
(c) foetal distress, foetal death or a congenital physical or m ental
impairment or birth defect;
(59) ‘device deficiency’ means any inadequacy in the identity, quality,
durability, reliability, safety or performance of an inve...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 13
(68) ‘field safety corrective action’ means corrective action t aken by a
manufacturer for technical or medical reasons to prevent or red uce
the risk of a serious incident in relation to a device made ava ilable
on the market;
(69) ‘field safety notice’ means a communication sent by a manu
facturer to users or customers in relation to a field safety co rrective
action;
(70) ‘harmonised standard’ means a European standard as defined in
point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
(71) ‘common specifications’ (CS) means a set of technical and/ or
clinical requirements, other than a standard, that provides a
means of complying with the legal obligations applicable to a
device, process or system.
Article 3
Amendment of certain definitions
The Commission is empowered to adopt delegated acts in accordan ce
with Article 115 in order to amend the definition of nanomateri al set out
in point (18) and the related definitions in points (19), (20) and (21) of
Article 2 in the light of technical and scientific progress and taking into
account definitions agreed at Union and international level.
Article 4
Regulatory status of products
1. Without prejudice to Article 2(2) of Directive 2001/83/EC, u pon a
duly substantiated request of a Member State, the Commission sh all,
after consulting the Medical Device Coordination Group establis hed
under Article 103 of this Regulation (‘MDCG’), by means of impl emen
ting acts, determine whether or not a specific product, or cate gory or
group of products, falls within the definitions of ‘medical dev ice’ or
‘accessory for a medical device’. Those implementing acts shall be
adopted in accordance with the examination procedure referred t o in
Article 114(3) of this Regulation.
2. The Commission may also, on its own initiative, after consul ting
the MDCG, decide, by means of implementing acts, on the issues
referred to in paragraph 1 of this Article. Those implementing acts
shall be adopted in accordance with the examination procedure
referred to in Article 114(3).
3. The Commission shall ensure that Member States share experti se
in the fields of medical devices, in vitro diagnostic medical devices,
medicinal products, human tissues and cells, cosmetics, biocide s, food
and, if necessary, other products, in order to determine the ap propriate
regulatory status of a product, or category or group of product s. ▼B
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(68) ‘field safety corrective action’ means corrective action t aken by a
manufacturer for technical or medical reasons to prevent or red uce
the risk of a serious incident in relation to a device made ava ilable
on the market;
(69) ‘field safety no...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 14
4. When deliberating on the possible regulatory status as a dev ice of
products involving medicinal products, human tissues and cells, biocides
or food products, the Commission shall ensure an appropriate le vel of
consultation of the European Medicines Agency (EMA), the Europe an
Chemicals Agency (ECHA) and the European Food Safety
Authority (EFSA), as relevant.
CHAPTER II
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO
SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC
OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT
Article 5
Placing on the market and putting into service
1. A device may be placed on the market or put into service onl y if it
complies with this Regulation when duly supplied and properly
installed, maintained and used in accordance with its intended purpose.
2. A device shall meet the general safety and performance
requirements set out in Annex I which apply to it, taking into
account its intended purpose.
3. Demonstration of conformity with the general safety and
performance requirements shall include a clinical evaluation in
accordance with Article 61.
4. Devices that are manufactured and used within health institu tions
shall be considered as having been put into service.
5. With the exception of the relevant general safety and perfor mance
requirements set out in Annex I, the requirements of this Regul ation
shall not apply to devices, manufactured and used only within h ealth
institutions established in the Union, provided that all of the following
conditions are met:
(a) the devices are not transferred to another legal entity,
(b) manufacture and use of the devices occur under appropriate quality
management systems,
(c) the health institution justifies in its documentation that the target
patient group's specific needs cannot be met, or cannot be met at the
appropriate level of performance by an equivalent device availa ble
on the market,
(d) the health institution provides information upon request on the use
of such devices to its competent authority, which shall include a
justification of their manufacturing, modification and use;
(e) the health institution draws up a declaration which it shal l make
publicly available, including:
(i) the name and address of the manufacturing health institutio n; ▼B
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4. When deliberating on the possible regulatory status as a dev ice of
products involving medicinal products, human tissues and cells, biocides
or food products, the Commission shall ensure an appropriate le vel of
consultation of the European Medici...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 15
(ii) the details necessary to identify the devices;
(iii) a declaration that the devices meet the general safety an d
performance requirements set out in Annex I to this Regulation
and, where applicable, information on which requirements are
not fully met with a reasoned justification therefor,
(f) the health institution draws up documentation that makes it possible
to have an understanding of the manufacturing facility, the man u
facturing process, the design and performance data of the devic es,
including the intended purpose, and that is sufficiently detail ed to
enable the competent authority to ascertain that the general sa fety
and performance requirements set out in Annex I to this Regulat ion
are met;
(g) the health institution takes all necessary measures to ensu re that all
devices are manufactured in accordance with the documentation
referred to in point (f), and
(h) the health institution reviews experience gained from clini cal use of
the devices and takes all necessary corrective actions.
Member States may require that such health institutions submit to the
competent authority any further relevant information about such devices
which have been manufactured and used on their territory.
Member States shall retain the right to restrict the manufactur e and
the use of any specific type of such devices and shall be permi tted
access to inspect the activities of the health institutions.
This paragraph shall not apply to devices that are manufactured on an
industrial scale.
6. In order to ensure the uniform application of Annex I, the
Commission may adopt implementing acts to the extent necessary to
resolve issues of divergent interpretation and of practical app lication.
Those implementing acts shall be adopted in accordance with the exa
mination procedure referred to in Article 114(3).
Article 6
Distance sales
1. A device offered by means of information society services, a s
defined in point (b) of Article 1(1) of Directive (EU) 2015/153 5, to a
natural or legal person established in the Union shall comply w ith this
Regulation.
2. Without prejudice to national law regarding the exercise of the
medical profession, a device that is not placed on the market b ut used in
the context of a commercial activity, whether in return for pay ment or
free of charge, for the provision of a diagnostic or therapeuti c service
offered by means of information society services as defined in point (b)
of Article 1(1) of Directive (EU) 2015/1535 or by other means o f
communication, directly or through intermediaries, to a natural or
legal person established in the Union shall comply with this Re gulation. ▼B
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(ii) the details necessary to identify the devices;
(iii) a declaration that the devices meet the general safety an d
performance requirements set out in Annex I to this Regulation
and, where applicable, information on which requirements are
not ful...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 16
3. Upon request by a competent authority, any natural or legal person
offering a device in accordance with paragraph 1 or providing a service
in accordance with paragraph 2 shall make available a copy of t he
EU declaration of conformity of the device concerned.
4. A Member State may, on grounds of protection of public healt h,
require a provider of information society services, as defined in
point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its
activity.
Article 7
Claims
►C1 In the labelling, instructions for use, making available, putt ing
into service and advertising of devices, it shall be prohibited to use text,
names, trade marks, pictures and ◄ figurative or other signs th at may
mislead the user or the patient with regard to the device's int ended
purpose, safety and performance by:
(a) ascribing functions and properties to the device which the device
does not have;
(b) creating a false impression regarding treatment or diagnosi s,
functions or properties which the device does not have;
(c) failing to inform the user or the patient of a likely risk associated
with the use of the device in line with its intended purpose;
(d) suggesting uses for the device other than those stated to f orm part of
the intended purpose for which the conformity assessment was
carried out.
Article 8
Use of harmonised standards
1. Devices that are in conformity with the relevant harmonised
standards, or the relevant parts of those standards, the refere nces of
which have been published in the Official Journal of the European
Union , shall be presumed to be in conformity with the requirements
of this Regulation covered by those standards or parts thereof.
The first subparagraph shall also apply to system or process
requirements to be fulfilled in accordance with this Regulation by
economic operators or sponsors, including those relating to qua lity
management systems, risk management, post-market surveillance
systems, clinical investigations, clinical evaluation or post-m arket
clinical follow-up (‘PMCF’).
References in this Regulation to harmonised standards shall be
understood as meaning harmonised standards the references of wh ich
have been published in the Official Journal of the European Union . ▼B
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3. Upon request by a competent authority, any natural or legal person
offering a device in accordance with paragraph 1 or providing a service
in accordance with paragraph 2 shall make available a copy of t he
EU declaration of conformity of the devic...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 17
2. References in this Regulation to harmonised standards shall also
include the monographs of the European Pharmacopoeia adopted in
accordance with the Convention on the Elaboration of a European Phar
macopoeia, in particular on surgical sutures and on interaction between
medicinal products and materials used in devices containing suc h
medicinal products, provided that references to those monograph s
have been published in the Official Journal of the European Union .
Article 9
Common specifications
1. Without prejudice to Article 1(2) and 17(5) and the deadline laid
down in those provisions, where no harmonised standards exist o r
where relevant harmonised standards are not sufficient, or wher e there
is a need to address public health concerns, the Commission, af ter
having consulted the MDCG, may, by means of implementing acts,
adopt common specifications (CS) in respect of the general safe ty and
performance requirements set out in Annex I, the technical docu men
tation set out in Annexes II and III, the clinical evaluation a nd
post-market clinical follow-up set out in Annex XIV or the requ irements
regarding clinical investigation set out in Annex XV. Those imp lemen
ting acts shall be adopted in accordance with the examination p rocedure
referred to in Article 114(3).
2. Devices that are in conformity with the CS referred to in
paragraph 1 shall be presumed to be in conformity with the
requirements of this Regulation covered by those CS or the rele vant
parts of those CS.
3. Manufacturers shall comply with the CS referred to in paragr aph 1
unless they can duly justify that they have adopted solutions t hat ensure
a level of safety and performance that is at least equivalent t hereto.
4. Notwithstanding paragraph 3, manufacturers of products liste d in
Annex XVI shall comply with the relevant CS for those products.
Article 10
General obligations of manufacturers
1. When placing their devices on the market or putting them int o
service, manufacturers shall ensure that they have been designe d and
manufactured in accordance with the requirements of this Regula tion.
2. Manufacturers shall establish, document, implement and maint ain
a system for risk management as described in Section 3 of Annex I .
3. Manufacturers shall conduct a clinical evaluation in accorda nce
with the requirements set out in Article 61 and Annex XIV, incl uding
a PMCF.
4. Manufacturers of devices other than custom-made devices shal l
draw up and keep up to date technical documentation for those
devices. The technical documentation shall be such as to allow the
conformity of the device with the requirements of this Regulati on to
be assessed. The technical documentation shall include the elem ents set
out in Annexes II and III. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 17
2. References in this Regulation to harmonised standards shall also
include the monographs of the European Pharmacopoeia adopted in
accordance with the Convention on the Elaboration of a European Phar
macopoeia, in particular on surgical sutures and...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 18
The Commission is empowered to adopt delegated acts in accordan ce
with Article 115 amending, in the light of technical progress, the
Annexes II and III.
5. Manufacturers of custom-made devices shall draw up, keep up to
date and keep available for competent authorities documentation in
accordance with Section 2 of Annex XIII.
6. Where compliance with the applicable requirements has been
demonstrated following the applicable conformity assessment pro cedure,
manufacturers of devices, other than custom-made or investigati onal
devices, shall draw up an EU declaration of conformity in accor dance
with Article 19, and affix the CE marking of conformity in acco rdance
with Article 20.
7. Manufacturers shall comply with the obligations relating to the
UDI system referred to in Article 27 and with the registration obli
gations referred to in Articles 29 and 31.
8. Manufacturers shall keep the technical documentation, the EU
declaration of conformity and, if applicable, a copy of any rel evant
certificate, including any amendments and supplements, issued i n
accordance with Article 56, available for the competent authori ties for
a period of at least 10 years after the last device covered by the
EU declaration of conformity has been placed on the market. In the
case of implantable devices, the period shall be at least 15 ye ars after
the last device has been placed on the market.
Upon request by a competent authority, the manufacturer shall, as
indicated therein, provide that technical documentation in its entirety
or a summary thereof.
A manufacturer with a registered place of business outside the Union
shall, in order to allow its authorised representative to fulfi l the tasks
mentioned in Article 11(3), ensure that the authorised represen tative has
the necessary documentation permanently available.
9. Manufacturers shall ensure that procedures are in place to k eep
series production in conformity with the requirements of this R egu
lation. Changes in device design or characteristics and changes in the
harmonised standards or CS by reference to which the conformity of a
device is declared shall be adequately taken into account in a timely
manner. Manufacturers of devices, other than investigational de vices,
shall establish, document, implement, maintain, keep up to date and
continually improve a quality management system that shall ensu re
compliance with this Regulation in the most effective manner an d in
a manner that is proportionate to the risk class and the type o f device.
The quality management system shall cover all parts and element s of a
manufacturer's organisation dealing with the quality of process es,
procedures and devices. It shall govern the structure, responsi bilities,
procedures, processes and management resources required to impl ement
the principles and actions necessary to achieve compliance with the
provisions of this Regulation.
The quality management system shall address at least the follow ing
aspects: ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 18
The Commission is empowered to adopt delegated acts in accordan ce
with Article 115 amending, in the light of technical progress, the
Annexes II and III.
5. Manufacturers of custom-made devices shall draw up, keep up to
date and keep available for c...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 19
(a) a strategy for regulatory compliance, including compliance with
conformity assessment procedures and procedures for management
of modifications to the devices covered by the system;
(b) identification of applicable general safety and performance
requirements and exploration of options to address those
requirements;
(c) responsibility of the management;
(d) resource management, including selection and control of sup pliers
and sub-contractors;
(e) risk management as set out in in Section 3 of Annex I;
(f) clinical evaluation in accordance with Article 61 and Annex XIV,
including PMCF;
(g) product realisation, including planning, design, developmen t,
production and service provision;
(h) verification of the UDI assignments made in accordance with
Article 27(3) to all relevant devices and ensuring consistency and
validity of information provided in accordance with Article 29;
(i) setting-up, implementation and maintenance of a post-market
surveillance system, in accordance with Article 83;
(j) handling communication with competent authorities, notified
bodies, other economic operators, customers and/or other
stakeholders;
(k) processes for reporting of serious incidents and field safe ty
corrective actions in the context of vigilance;
(l) management of corrective and preventive actions and verific ation
of their effectiveness;
(m) processes for monitoring and measurement of output, data an alysis
and product improvement.
10. Manufacturers of devices shall implement and keep up to dat e
the post-market surveillance system in accordance with Article 83.
11. Manufacturers shall ensure that the device is accompanied b y the
information set out in Section 23 of Annex I in an official Uni on
language(s) determined by the Member State in which the device is
made available to the user or patient. The particulars on the l abel
shall be indelible, easily legible and clearly comprehensible t o the
intended user or patient.
12. Manufacturers who consider or have reason to believe that a
device which they have placed on the market or put into service is
not in conformity with this Regulation shall immediately take t he
necessary corrective action to bring that device into conformit y, to
withdraw it or to recall it, as appropriate. They shall inform the
distributors of the device in question and, where applicable, t he auth
orised representative and importers accordingly. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 19
(a) a strategy for regulatory compliance, including compliance with
conformity assessment procedures and procedures for management
of modifications to the devices covered by the system;
(b) identification of applicable general safety and performance ...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 20
Where the device presents a serious risk, manufacturers shall i mmedi
ately inform the competent authorities of the Member States in which
they made the device available and, where applicable, the notif ied body
that issued a certificate for the device in accordance with Art icle 56, in
particular, of the non-compliance and of any corrective action taken.
13. Manufacturers shall have a system for recording and reporti ng of
incidents and field safety corrective actions as described in A rticles 87
and 88.
14. Manufacturers shall, upon request by a competent authority,
provide it with all the information and documentation necessary to
demonstrate the conformity of the device, in an official Union
language determined by the Member State concerned. The competen t
authority of the Member State in which the manufacturer has its
registered place of business may require that the manufacturer provide
samples of the device free of charge or, where that is impracti cable,
grant access to the device. Manufacturers shall cooperate with a
competent authority, at its request, on any corrective action t aken to
eliminate or, if that is not possible, mitigate the risks posed by devices
which they have placed on the market or put into service.
If the manufacturer fails to cooperate or the information and d ocumen
tation provided is incomplete or incorrect, the competent autho rity may,
in order to ensure the protection of public health and patient safety, take
all appropriate measures to prohibit or restrict the device's b eing made
available on its national market, to withdraw the device from t hat
market or to recall it until the manufacturer cooperates or pro vides
complete and correct information.
If a competent authority considers or has reason to believe tha t a device
has caused damage, it shall, upon request, facilitate the provi sion of the
information and documentation referred to in the first subparag raph to
the potentially injured patient or user and, as appropriate, th e patient's or
user's successor in title, the patient's or user's health insur ance company
or other third parties affected by the damage caused to the pat ient or
user, without prejudice to data protection rules and, unless th ere is an
overriding public interest in disclosure, without prejudice to the
protection of intellectual property rights.
The competent authority need not comply with the obligation lai d down
in the third subparagraph where disclosure of the information a nd docu
mentation referred to in the first subparagraph is ordinarily d ealt with in
the context of legal proceedings.
▼C1
15. Where manufacturers have their devices designed or manu
factured by another legal or natural person the information on the
identity of that person shall be part of the information to be
submitted in accordance with Article 29(4).
▼B
16. Natural or legal persons may claim compensation for damage
caused by a defective device in accordance with applicable Unio n and
national law. ▼B
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Where the device presents a serious risk, manufacturers shall i mmedi
ately inform the competent authorities of the Member States in which
they made the device available and, where applicable, the notif ied body
that issued a certificate for the devic...
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02017R0745 — EN — 10.01.2025 — 005.001 — 21
Manufacturers shall, in a manner that is proportionate to the r isk class,
type of device and the size of the enterprise, have measures in place to
provide sufficient financial coverage in respect of their poten tial liability
under Directive 85/374/EEC, without prejudice to more protectiv e
measures under national law.
▼M5
Article 10a
Obligations in case of interruption or discontinuation of supply of
certain devices
1. Where a manufacturer anticipates an interruption or a discon
tinuation of the supply of a device, other than a custom-made d evice,
and where it is reasonably foreseeable that such interruption o r discon
tinuation could result in serious harm or a risk of serious har m to
patients or public health in one or more Member States, the man u
facturer shall inform the competent authority of the Member Sta te
where it or its authorised representative is established, as we ll as the
economic operators, health institutions and healthcare professi onals to
whom it directly supplies the device, of the anticipated interr uption or
discontinuation.
The information referred to in the first subparagraph shall, ot her than in
exceptional circumstances, be provided at least 6 months before the
anticipated interruption or discontinuation. The manufacturer s hall
specify the reasons for the interruption or discontinuation in the
information provided to the competent authority.
2. The competent authority that has received the information re ferred
to in paragraph 1 shall, without undue delay, inform the compet ent
authorities of the other Member States and the Commission of th e
anticipated interruption or discontinuation.
3. The economic operators who have received the information fro m
the manufacturer in accordance with paragraph 1 or from another
economic operator in the supply chain shall, without undue dela y,
inform any other economic operators, health institutions and he althcare
professionals to whom they directly supply the device, of the a nticipated
interruption or discontinuation.
▼B
Article 11
Authorised representative
1. Where the manufacturer of a device is not established in
a Member State, the device may only be placed on the Union mark et
if the manufacturer designates a sole authorised representative . ▼B
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Manufacturers shall, in a manner that is proportionate to the r isk class,
type of device and the size of the enterprise, have measures in place to
provide sufficient financial coverage in respect of their poten tial liability
under Directive 85/374/...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 22
2. The designation shall constitute the authorised representati ve's
mandate, it shall be valid only when accepted in writing by the auth
orised representative and shall be effective at least for all d evices of the
same generic device group.
3. The authorised representative shall perform the tasks specif ied in
the mandate agreed between it and the manufacturer. The authori sed
representative shall provide a copy of the mandate to the compe tent
authority, upon request.
The mandate shall require, and the manufacturer shall enable, t he auth
orised representative to perform at least the following tasks i n relation to
the devices that it covers:
(a) verify that the EU declaration of conformity and technical docu
mentation have been drawn up and, where applicable, that an app ro
priate conformity assessment procedure has been carried out by the
manufacturer;
(b) keep available a copy of the technical documentation, the E U
declaration of conformity and, if applicable, a copy of the
relevant certificate, including any amendments and supplements,
issued in accordance with Article 56, at the disposal of compet ent
authorities for the period referred to in Article 10(8);
(c) comply with the registration obligations laid down in Artic le 31 and
verify that the manufacturer has complied with the registration obli
gations laid down in Articles 27 and 29;
(d) in response to a request from a competent authority, provid e that
competent authority with all the information and documentation
necessary to demonstrate the conformity of a device, in an
official Union language determined by the Member State concerne d;
(e) forward to the manufacturer any request by a competent auth ority of
the Member State in which the authorised representative has its
registered place of business for samples, or access to a device
and verify that the competent authority receives the samples or is
given access to the device;
(f) cooperate with the competent authorities on any preventive or
corrective action taken to eliminate or, if that is not possibl e,
mitigate the risks posed by devices; ▼B
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2. The designation shall constitute the authorised representati ve's
mandate, it shall be valid only when accepted in writing by the auth
orised representative and shall be effective at least for all d evices of the
same generic device group.
3. Th...
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02017R0745 — EN — 10.01.2025 — 005.001 — 23
(g) immediately inform the manufacturer about complaints and re ports
from healthcare professionals, patients and users about suspect ed
incidents related to a device for which they have been designat ed;
(h) terminate the mandate if the manufacturer acts contrary to its obli
gations under this Regulation.
4. The mandate referred to in paragraph 3 of this Article shall not
delegate the manufacturer's obligations laid down in Article 10 (1), (2),
(3), (4), (6), (7), (9), (10), (11) and (12).
5. Without prejudice to paragraph 4 of this Article, where the manu
facturer is not established in a Member State and has not compl ied with
the obligations laid down in Article 10, the authorised represe ntative
shall be legally liable for defective devices on the same basis as, and
jointly and severally with, the manufacturer.
6. An authorised representative who terminates its mandate on t he
ground referred to in point (h) of paragraph 3 shall immediatel y inform
the competent authority of the Member State in which it is esta blished
and, where applicable, the notified body that was involved in t he
conformity assessment for the device of the termination of the
mandate and the reasons therefor.
7. Any reference in this Regulation to the competent authority of the
Member State in which the manufacturer has its registered place of
business shall be understood as a reference to the competent au thority
of the Member State in which the authorised representative, des ignated
by a manufacturer referred to in paragraph 1, has its registere d place of
business.
Article 12
Change of authorised representative
The detailed arrangements for a change of authorised representa tive
shall be clearly defined in an agreement between the manufactur er,
where practicable the outgoing authorised representative, and t he
incoming authorised representative. That agreement shall addres s at
least the following aspects:
(a) the date of termination of the mandate of the outgoing auth orised
representative and date of beginning of the mandate of the inco ming
authorised representative;
(b) the date until which the outgoing authorised representative may be
indicated in the information supplied by the manufacturer, incl uding
any promotional material;
(c) the transfer of documents, including confidentiality aspect s and
property rights;
(d) the obligation of the outgoing authorised representative af ter the end
of the mandate to forward to the manufacturer or incoming auth
orised representative any complaints or reports from healthcare
professionals, patients or users about suspected incidents rela ted to
a device for which it had been designated as authorised
representative. ▼B
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(g) immediately inform the manufacturer about complaints and re ports
from healthcare professionals, patients and users about suspect ed
incidents related to a device for which they have been designat ed;
(h) terminate the mandate if the manufacturer ...
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02017R0745 — EN — 10.01.2025 — 005.001 — 24
Article 13
General obligations of importers
1. Importers shall place on the Union market only devices that are in
conformity with this Regulation.
2. In order to place a device on the market, importers shall ve rify
that:
(a) the device has been CE marked and that the EU declaration o f
conformity of the device has been drawn up;
(b) a manufacturer is identified and that an authorised represe ntative in
accordance with Article 11 has been designated by the
manufacturer;
(c) the device is labelled in accordance with this Regulation a nd accom
panied by the required instructions for use;
(d) where applicable, a UDI has been assigned by the manufactur er in
accordance with Article 27.
Where an importer considers or has reason to believe that a dev ice is
not in conformity with the requirements of this Regulation, it shall not
place the device on the market until it has been brought into c onformity
and shall inform the manufacturer and the manufacturer's author ised
representative. Where the importer considers or has reason to b elieve
that the device presents a serious risk or is a falsified devic e, it shall
also inform the competent authority of the Member State in whic h the
importer is established.
3. Importers shall indicate on the device or on its packaging o r in a
document accompanying the device their name, registered trade n ame or
registered trade mark, their registered place of business and t he address
at which they can be contacted, so that their location can be e stablished.
They shall ensure that any additional label does not obscure an y
information on the label provided by the manufacturer.
4. Importers shall verify that the device is registered in the electronic
system in accordance with Article 29. Importers shall add their details to
the registration in accordance with Article 31.
5. Importers shall ensure that, while a device is under their r espon
sibility, storage or transport conditions do not jeopardise its compliance
with the general safety and performance requirements set out in Annex I
and shall comply with the conditions set by the manufacturer, w here
available.
6. Importers shall keep a register of complaints, of non-confor ming
devices and of recalls and withdrawals, and provide the manufac turer,
authorised representative and distributors with any information
requested by them, in order to allow them to investigate compla ints. ▼B
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Article 13
General obligations of importers
1. Importers shall place on the Union market only devices that are in
conformity with this Regulation.
2. In order to place a device on the market, importers shall ve rify
that:
(a) the device has been...
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02017R0745 — EN — 10.01.2025 — 005.001 — 25
7. Importers who consider or have reason to believe that a devi ce
which they have placed on the market is not in conformity with this
Regulation shall immediately inform the manufacturer and its au thorised
representative. Importers shall co-operate with the manufacture r, the
manufacturer's authorised representative and the competent auth orities
to ensure that the necessary corrective action to bring that de vice into
conformity, to withdraw or recall it is taken. Where the device presents
a serious risk, they shall also immediately inform the competen t auth
orities of the Member States in which they made the device avai lable
and, if applicable, the notified body that issued a certificate in
accordance with Article 56 for the device in question, giving d etails,
in particular, of the non-compliance and of any corrective acti on taken.
8. Importers who have received complaints or reports from healt hcare
professionals, patients or users about suspected incidents rela ted to a
device which they have placed on the market shall immediately f orward
this information to the manufacturer and its authorised represe ntative.
9. Importers shall, for the period referred to in Article 10(8) , keep a
copy of the EU declaration of conformity and, if applicable, a copy of
any relevant certificate, including any amendments and suppleme nts,
issued in accordance with Article 56.
10. Importers shall cooperate with competent authorities, at th e
latters' request, on any action taken to eliminate or, if that is not
possible, mitigate the risks posed by devices which they have p laced
on the market. Importers, upon request by a competent authority of the
Member State in which the importer has its registered place of business,
shall provide samples of the device free of charge or, where th at is
impracticable, grant access to the device.
Article 14
General obligations of distributors
1. When making a device available on the market, distributors s hall,
in the context of their activities, act with due care in relati on to the
requirements applicable.
2. Before making a device available on the market, distributors shall
verify that all of the following requirements are met:
(a) the device has been CE marked and that the EU declaration o f
conformity of the device has been drawn up;
(b) the device is accompanied by the information to be supplied by the
manufacturer in accordance with Article 10(11);
(c) for imported devices, the importer has complied with the
requirements set out in Article 13(3);
(d) that, where applicable, a UDI has been assigned by the
manufacturer.
In order to meet the requirements referred to in points (a), (b ) and (d) of
the first subparagraph the distributor may apply a sampling met hod that
is representative of the devices supplied by that distributor. ▼B
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7. Importers who consider or have reason to believe that a devi ce
which they have placed on the market is not in conformity with this
Regulation shall immediately inform the manufacturer and its au thorised
representative. Importers shall co-operate ...
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02017R0745 — EN — 10.01.2025 — 005.001 — 26
Where a distributor considers or has reason to believe that a d evice is
not in conformity with the requirements of this Regulation, it shall not
make the device available on the market until it has been broug ht into
conformity, and shall inform the manufacturer and, where applic able,
the manufacturer's authorised representative, and the importer. Where
the distributor considers or has reason to believe that the dev ice presents
a serious risk or is a falsified device, it shall also inform t he competent
authority of the Member State in which it is established.
3. Distributors shall ensure that, while the device is under th eir
responsibility, storage or transport conditions comply with the
conditions set by the manufacturer.
4. Distributors that consider or have reason to believe that a device
which they have made available on the market is not in conformi ty with
this Regulation shall immediately inform the manufacturer and, where
applicable, the manufacturer's authorised representative and th e
importer. Distributors shall co-operate with the manufacturer a nd,
where applicable, the manufacturer's authorised representative, and the
importer, and with competent authorities to ensure that the nec essary
corrective action to bring that device into conformity, to with draw or to
recall it, as appropriate, is taken. Where the distributor cons iders or has
reason to believe that the device presents a serious risk, it s hall also
immediately inform the competent authorities of the Member Stat es in
which it made the device available, giving details, in particul ar, of the
non-compliance and of any corrective action taken.
5. Distributors that have received complaints or reports from
healthcare professionals, patients or users about suspected inc idents
related to a device they have made available, shall immediately
forward this information to the manufacturer and, where applica ble,
the manufacturer's authorised representative, and the importer. They
shall keep a register of complaints, of non-conforming devices and of
recalls and withdrawals, and keep the manufacturer and, where
available, the authorised representative and the importer infor med of
such monitoring and provide them with any information upon thei r
request.
6. Distributors shall, upon request by a competent authority, p rovide
it with all the information and documentation that is at their disposal
and is necessary to demonstrate the conformity of a device.
Distributors shall be considered to have fulfilled the obligati on referred
to in the first subparagraph when the manufacturer or, where ap plicable,
the authorised representative for the device in question provid es the
required information. Distributors shall cooperate with compete nt
authorities, at their request, on any action taken to eliminate the risks
posed by devices which they have made available on the market.
Distributors, upon request by a competent authority, shall prov ide free
samples of the device or, where that is impracticable, grant ac cess to the
device.
Article 15
Person responsible for regulatory compliance
1. Manufacturers shall have available within their organisation at
least one person responsible for regulatory compliance who poss esses
the requisite expertise in the field of medical devices. The re quisite
expertise shall be demonstrated by either of the following qual ifications: ▼B
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Where a distributor considers or has reason to believe that a d evice is
not in conformity with the requirements of this Regulation, it shall not
make the device available on the market until it has been broug ht into
conformity, and shall inform the ...
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02017R0745 — EN — 10.01.2025 — 005.001 — 27
(a) a diploma, certificate or other evidence of formal qualific ation,
awarded on completion of a university degree or of a course of
study recognised as equivalent by the Member State concerned, i n
law, medicine, pharmacy, engineering or another relevant scient ific
discipline, and at least one year of professional experience in regu
latory affairs or in quality management systems relating to med ical
devices;
(b) four years of professional experience in regulatory affairs or in
quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifi
cations, manufacturers of custom-made devices may demonstrate t he
requisite expertise referred to in the first subparagraph by ha ving at
least two years of professional experience within a relevant fi eld of
manufacturing.
2. Micro and small enterprises within the meaning of Commission
Recommendation 2003/361/EC ( 1 ) shall not be required to have the
person responsible for regulatory compliance within their organ isation
but shall have such person permanently and continuously at thei r
disposal.
3. The person responsible for regulatory compliance shall at le ast be
responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in
accordance with the quality management system under which the
devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of confo rmity
are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in
accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are
fulfilled;
(e) in the case of investigational devices, the statement refer red to in
Section 4.1 of Chapter II of Annex XV is issued.
4. If a number of persons are jointly responsible for regulator y
compliance in accordance with paragraphs 1, 2 and 3, their resp ective
areas of responsibility shall be stipulated in writing.
5. The person responsible for regulatory compliance shall suffe r no
disadvantage within the manufacturer's organisation in relation to the
proper fulfilment of his or her duties, regardless of whether o r not they
are employees of the organisation.
6. Authorised representatives shall have permanently and
continuously at their disposal at least one person responsible for regu
latory compliance who possesses the requisite expertise regardi ng the
regulatory requirements for medical devices in the Union. The r equisite
expertise shall be demonstrated by either of the following qual ifications: ▼B
( 1 ) Commission Recommendation 2003/361/ΕC of 6 May 2003 concernin g the
definition of micro, small and medium-sized enterprises (OJ L 1 24,
20.5.2003, p. 36).
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 27
(a) a diploma, certificate or other evidence of formal qualific ation,
awarded on completion of a university degree or of a course of
study recognised as equivalent by the Member State concerned, i n
law, medicine, pharmacy, engineering or another rel...
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02017R0745 — EN — 10.01.2025 — 005.001 — 28
(a) a diploma, certificate or other evidence of formal qualific ation,
awarded on completion of a university degree or of a course of
study recognised as equivalent by the Member State concerned, i n
law, medicine, pharmacy, engineering or another relevant scient ific
discipline, and at least one year of professional experience in regu
latory affairs or in quality management systems relating to med ical
devices;
(b) four years of professional experience in regulatory affairs or in
quality management systems relating to medical devices.
Article 16
Cases in which obligations of manufacturers apply to importers,
distributors or other persons
1. A distributor, importer or other natural or legal person sha ll
assume the obligations incumbent on manufacturers if it does an y of
the following:
(a) makes available on the market a device under its name, regi stered
trade name or registered trade mark, except in cases where a
distributor or importer enters into an agreement with a manufac turer
whereby the manufacturer is identified as such on the label and is
responsible for meeting the requirements placed on manufacturer s in
this Regulation;
(b) changes the intended purpose of a device already placed on the
market or put into service;
(c) modifies a device already placed on the market or put into service
in such a way that compliance with the applicable requirements may
be affected.
The first subparagraph shall not apply to any person who, while not
considered a manufacturer as defined in point (30) of Article 2 ,
assembles or adapts for an individual patient a device already on the
market without changing its intended purpose.
2. For the purposes of point (c) of paragraph 1, the following shall
not be considered to be a modification of a device that could a ffect its
compliance with the applicable requirements:
(a) provision, including translation, of the information suppli ed by the
manufacturer, in accordance with Section 23 of Annex I, relatin g to
a device already placed on the market and of further informatio n
which is necessary in order to market the device in the relevan t
Member State;
(b) changes to the outer packaging of a device already placed o n the
market, including a change of pack size, if the repackaging is
necessary in order to market the device in the relevant Member State
and if it is carried out in such conditions that the original c ondition
of the device cannot be affected by it. In the case of devices placed
on the market in sterile condition, it shall be presumed that t he
original condition of the device is adversely affected if the
packaging that is necessary for maintaining the sterile conditi on is
opened, damaged or otherwise negatively affected by the
repackaging. ▼B
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(a) a diploma, certificate or other evidence of formal qualific ation,
awarded on completion of a university degree or of a course of
study recognised as equivalent by the Member State concerned, i n
law, medicine, pharmacy, engineering or another rel...
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02017R0745 — EN — 10.01.2025 — 005.001 — 29
3. A distributor or importer that carries out any of the activi ties
mentioned in points (a) and (b) of paragraph 2 shall indicate o n the
device or, where that is impracticable, on its packaging or in a
document accompanying the device, the activity carried out toge ther
with its name, registered trade name or registered trade mark, registered
place of business and the address at which it can be contacted, so that
its location can be established.
Distributors and importers shall ensure that they have in place a quality
management system that includes procedures which ensure that th e
translation of information is accurate and up-to-date, and that the
activities mentioned in points (a) and (b) of paragraph 2 are
performed by a means and under conditions that preserve the ori ginal
condition of the device and that the packaging of the repackage d device
is not defective, of poor quality or untidy. The quality manage ment
system shall cover, inter alia , procedures ensuring that the distributor
or importer is informed of any corrective action taken by the m anu
facturer in relation to the device in question in order to resp ond to safety
issues or to bring it into conformity with this Regulation.
4. At least 28 days prior to making the relabelled or repackage d
device available on the market, distributors or importers carry ing out
any of the activities mentioned in points (a) and (b) of paragr aph 2 shall
inform the manufacturer and the competent authority of the
Member State in which they plan to make the device available of the
intention to make the relabelled or repackaged device available and,
upon request, shall provide the manufacturer and the competent
authority with a sample or mock-up of the relabelled or repacka ged
device, including any translated label and instructions for use . Within
the same period of 28 days, the distributor or importer shall s ubmit to
the competent authority a certificate, issued by a notified bod y
designated for the type of devices that are subject to activiti es
mentioned in points (a) and (b) of paragraph 2, attesting that the
quality management system of the distributer or importer compli es
with the requirements laid down in paragraph 3.
Article 17
Single-use devices and their reprocessing
1. Reprocessing and further use of single-use devices may only take
place where permitted by national law and only in accordance wi th this
Article.
2. Any natural or legal person who reprocesses a single-use dev ice to
make it suitable for further use within the Union shall be cons idered to
be the manufacturer of the reprocessed device and shall assume the
obligations incumbent on manufacturers laid down in this Regula tion,
which include obligations relating to the traceability of the r eprocessed
device in accordance with Chapter III of this Regulation. The r epro
cessor of the device shall be considered to be a producer for t he purpose
of Article 3(1) of Directive 85/374/EEC. ▼B
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3. A distributor or importer that carries out any of the activi ties
mentioned in points (a) and (b) of paragraph 2 shall indicate o n the
device or, where that is impracticable, on its packaging or in a
document accompanying the device, the activity ...
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02017R0745 — EN — 10.01.2025 — 005.001 — 30
3. By way of derogation from paragraph 2, as regards single-use
devices that are reprocessed and used within a health instituti on,
Member States may decide not to apply all of the rules relating to
manufacturers' obligations laid down in this Regulation provide d that
they ensure that:
(a) the safety and performance of the reprocessed device is equ ivalent
to that of the original device and the requirements in points ( a), (b),
(d), (e), (f), (g) and (h) of Article 5(5) are complied with;
(b) the reprocessing is performed in accordance with CS detaili ng the
requirements concerning:
— risk management, including the analysis of the construction a nd
material, related properties of the device (reverse engineering )
and procedures to detect changes in the design of the original
device as well as of its planned application after reprocessing ,
— the validation of procedures for the entire process, includin g
cleaning steps,
— the product release and performance testing,
— the quality management system,
— the reporting of incidents involving devices that have been
reprocessed, and
— the traceability of reprocessed devices.
Member States shall encourage, and may require, health institut ions to
provide information to patients on the use of reprocessed devic es within
the health institution and, where appropriate, any other releva nt
information on the reprocessed devices that patients are treate d with.
Member States shall notify the Commission and the other Member States
of the national provisions introduced pursuant to this paragrap h and the
grounds for introducing them. The Commission shall keep the
information publicly available.
4. Member States may choose to apply the provisions referred to in
paragraph 3 also as regards single-use devices that are reproce ssed by
an external reprocessor at the request of a health institution, provided
that the reprocessed device in its entirety is returned to that health
institution and the external reprocessor complies with the requ irements
referred to in points (a) and (b) of paragraph 3.
5. The Commission shall adopt, in accordance with Article 9(1), the
necessary CS referred to in point (b) of paragraph 3 by ►M1 26 May
2021 ◄. Those CS shall be consistent with the latest scientific evidence
and shall address the application of the general requirements o n safety
and performance laid down in in this Regulation. In the event t hat those
CS are not adopted by ►M1 26 May 2021 ◄, reprocessing shall be
performed in accordance with any relevant harmonised standards and
national provisions that cover the aspects outlined in point (b ) of
paragraph 3. Compliance with CS or, in the absence of CS, with any
relevant harmonised standards and national provisions, shall be certified
by a notified body. ▼B
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3. By way of derogation from paragraph 2, as regards single-use
devices that are reprocessed and used within a health instituti on,
Member States may decide not to apply all of the rules relating to
manufacturers' obligations laid down in this Regul...
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6. Only single-use devices that have been placed on the market in
accordance with this Regulation, or prior to ►M1 26 May 2021 ◄ in
accordance with Directive 93/42/EEC, may be reprocessed.
7. Only reprocessing of single-use devices that is considered s afe
according to the latest scientific evidence may be carried out.
8. The name and address of the legal or natural person referred to in
paragraph 2 and the other relevant information referred to in S ection 23
of Annex I shall be indicated on the label and, where applicabl e, in the
instructions for use of the reprocessed device.
The name and address of the manufacturer of the original single -use
device shall no longer appear on the label, but shall be mentio ned in the
instructions for use of the reprocessed device.
9. A Member State that permits reprocessing of single-use devic es
may maintain or introduce national provisions that are stricter than those
laid down in this Regulation and which restrict or prohibit, wi thin its
territory, the following:
(a) the reprocessing of single-use devices and the transfer of single-use
devices to another Member State or to a third country with a vi ew
to their reprocessing;
(b) the making available or further use of reprocessed single-u se
devices.
Member States shall notify the Commission and the other Member States
of those national provisions. The Commission shall make such
information publicly available.
10. The Commission shall by 27 May 2024 draw up a report on the
operation of this Article and submit it to the European Parliam ent and to
the Council. On the basis of that report, the Commission shall, if
appropriate, make proposals for amendments to this Regulation.
Article 18
Implant card and information to be supplied to the patient with an
implanted device
1. The manufacturer of an implantable device shall provide toge ther
with the device the following:
(a) information allowing the identification of the device, incl uding the
device name, serial number, lot number, the UDI, the device mod el,
as well as the name, address and the website of the manufacture r;
(b) any warnings, precautions or measures to be taken by the pa tient or
a healthcare professional with regard to reciprocal interferenc e with
reasonably foreseeable external influences, medical examination s or
environmental conditions;
(c) any information about the expected lifetime of the device a nd any
necessary follow-up; ▼B
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6. Only single-use devices that have been placed on the market in
accordance with this Regulation, or prior to ►M1 26 May 2021 ◄ in
accordance with Directive 93/42/EEC, may be reprocessed.
7. Only reprocessing of single-use devices that is considere...
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02017R0745 — EN — 10.01.2025 — 005.001 — 32
(d) any other information to ensure safe use of the device by t he
patient, including the information in point (u) of Section 23.4 of
Annex I.
The information referred to in the first subparagraph shall be provided,
for the purpose of making it available to the particular patien t who has
been implanted with the device, by any means that allow rapid a ccess to
that information and shall be stated in the language(s) determi ned by the
concerned Member State. The information shall be written in a w ay that
is readily understood by a lay person and shall be updated wher e
appropriate. Updates of the information shall be made available to the
patient via the website mentioned in point (a) of the first sub paragraph.
In addition, the manufacturer shall provide the information ref erred to in
point (a) of the first subparagraph on an implant card delivere d with the
device.
2. Member States shall require health institutions to make the
information referred to in paragraph 1 available, by any means that
allow rapid access to that information, to any patients who hav e been
implanted with the device, together with the implant card, whic h shall
bear their identity.
3. The following implants shall be exempted from the obligation s
laid down in this Article: sutures, staples, dental fillings, d ental
braces, tooth crowns, screws, wedges, plates, wires, pins, clip s and
connectors. The Commission is empowered to adopt delegated acts in
accordance with Article 115 to amend this list by adding other types of
implants to it or by removing implants therefrom.
Article 19
EU declaration of conformity
1. The EU declaration of conformity shall state that the requir ements
specified in this Regulation have been fulfilled in relation to the device
that is covered. The manufacturer shall continuously update the
EU declaration of conformity. The EU declaration of conformity
shall, as a minimum, contain the information set out in Annex I V
and shall be translated into an official Union language or lang uages
required by the Member State(s) in which the device is made ava ilable.
2. Where, concerning aspects not covered by this Regulation, de vices
are subject to other Union legislation which also requires an E U
declaration of conformity by the manufacturer that fulfilment o f the
requirements of that legislation has been demonstrated, a singl e
EU declaration of conformity shall be drawn up in respect of al l
Union acts applicable to the device. The declaration shall cont ain all
the information required for identification of the Union legisl ation to
which the declaration relates.
3. By drawing up the EU declaration of conformity, the manufact urer
shall assume responsibility for compliance with the requirement s of this
Regulation and all other Union legislation applicable to the de vice. ▼B
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(d) any other information to ensure safe use of the device by t he
patient, including the information in point (u) of Section 23.4 of
Annex I.
The information referred to in the first subparagraph shall be provided,
for the purpose of making it ava...
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02017R0745 — EN — 10.01.2025 — 005.001 — 33
4. The Commission is empowered to adopt delegated acts in
accordance with Article 115 amending the minimum content of the
EU declaration of conformity set out in Annex IV in the light o f
technical progress.
Article 20
CE marking of conformity
1. Devices, other than custom-made or investigational devices,
considered to be in conformity with the requirements of this Re gulation
shall bear the CE marking of conformity, as presented in Annex V.
2. The CE marking shall be subject to the general principles se t out
in Article 30 of Regulation (EC) No 765/2008.
3. The CE marking shall be affixed visibly, legibly and indelib ly to
the device or its sterile packaging. Where such affixing is not possible
or not warranted on account of the nature of the device, the CE marking
shall be affixed to the packaging. The CE marking shall also ap pear in
any instructions for use and on any sales packaging.
4. The CE marking shall be affixed before the device is placed on the
market. It may be followed by a pictogram or any other mark ind icating
a special risk or use.
5. Where applicable, the CE marking shall be followed by the id enti
fication number of the notified body responsible for the confor mity
assessment procedures set out in Article 52. The identification number
shall also be indicated in any promotional material which menti ons that
a device fulfils the requirements for CE marking.
6. Where devices are subject to other Union legislation which a lso
provides for the affixing of the CE marking, the CE marking sha ll
indicate that the devices also fulfil the requirements of that other
legislation.
Article 21
Devices for special purposes
1. Member States shall not create obstacles to:
(a) investigational devices being supplied to an investigator f or the
purpose of a clinical investigation if they meet the conditions laid
down in Articles 62 to 80 and Article 82, in the implementing a cts
adopted pursuant to Article 81 and in Annex XV;
(b) custom-made devices being made available on the market if
Article 52(8) and Annex XIII have been complied with.
The devices referred to in the first subparagraph shall not bea r the CE
marking, with the exception of the devices referred to in Artic le 74.
2. Custom-made devices shall be accompanied by the statement
referred to in Section 1 of Annex XIII, which shall be made ava ilable
to the particular patient or user identified by name, an acrony m or a
numerical code. ▼B
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4. The Commission is empowered to adopt delegated acts in
accordance with Article 115 amending the minimum content of the
EU declaration of conformity set out in Annex IV in the light o f
technical progress.
Article 20
CE marking of conformity
...
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02017R0745 — EN — 10.01.2025 — 005.001 — 34
Member States may require that the manufacturer of a custom-mad e
device submit to the competent authority a list of such devices which
have been made available in their territory.
3. At trade fairs, exhibitions, demonstrations or similar event s,
Member States shall not create obstacles to the showing of devi ces
which do not comply with this Regulation, provided a visible si gn
clearly indicates that such devices are intended for presentati on or
demonstration purposes only and cannot be made available until they
have been brought into compliance with this Regulation.
Article 22
Systems and procedure packs
1. Natural or legal persons shall draw up a statement if they c ombine
devices bearing a CE marking with the following other devices o r
products, in a manner that is compatible with the intended purp ose of
the devices or other products and within the limits of use spec ified by
their manufacturers, in order to place them on the market as a system or
procedure pack:
(a) other devices bearing the CE marking;
(b) in vitro diagnostic medical devices bearing the CE marking in
conformity with Regulation (EU) 2017/746;
(c) other products which are in conformity with legislation tha t applies
to those products only where they are used within a medical
procedure or their presence in the system or procedure pack is
otherwise justified.
2. In the statement made pursuant to paragraph 1, the natural o r legal
person concerned shall declare that:
(a) they verified the mutual compatibility of the devices and, if
applicable other products, in accordance with the manufacturers '
instructions and have carried out their activities in accordanc e
with those instructions;
(b) they packaged the system or procedure pack and supplied rel evant
information to users incorporating the information to be suppli ed by
the manufacturers of the devices or other products which have b een
put together;
(c) the activity of combining devices and, if applicable, other products
as a system or procedure pack was subject to appropriate method s
of internal monitoring, verification and validation.
3. Any natural or legal person who sterilises systems or proced ure
packs referred to in paragraph 1 for the purpose of placing the m on the
market shall, at their choice, apply one of the procedures set out in
Annex IX or the procedure set out in Part A of Annex XI. The ap pli
cation of those procedures and the involvement of the notified body ▼B
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Member States may require that the manufacturer of a custom-mad e
device submit to the competent authority a list of such devices which
have been made available in their territory.
3. At trade fairs, exhibitions, demonstrations or similar event s,
...
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02017R0745 — EN — 10.01.2025 — 005.001 — 35
shall be limited to the aspects of the procedure relating to en suring
sterility until the sterile packaging is opened or damaged. The natural
or legal person shall draw up a statement declaring that steril isation has
been carried out in accordance with the manufacturer's instruct ions.
4. Where the system or procedure pack incorporates devices whic h
do not bear the CE marking or where the chosen combination of d evices
is not compatible in view of their original intended purpose, o r where
the sterilisation has not been carried out in accordance with t he manu
facturer's instructions, the system or procedure pack shall be treated as a
device in its own right and shall be subject to the relevant co nformity
assessment procedure pursuant to Article 52. The natural or leg al person
shall assume the obligations incumbent on manufacturers.
5. The systems or procedure packs referred to in paragraph 1 of this
Article shall not themselves bear an additional CE marking but they
shall bear the name, registered trade name or registered trade mark of
the person referred to in paragraphs 1 and 3 of this Article as well as the
address at which that person can be contacted, so that the pers on's
location can be established. Systems or procedure packs shall b e accom
panied by the information referred to in Section 23 of Annex I. The
statement referred to in paragraph 2 of this Article shall be k ept at the
disposal of the competent authorities, after the system or proc edure pack
has been put together, for the period that is applicable under
Article 10(8) to the devices that have been combined. Where tho se
periods differ, the longest period shall apply.
Article 23
Parts and components
1. Any natural or legal person who makes available on the marke t an
item specifically intended to replace an identical or similar i ntegral part
or component of a device that is defective or worn in order to maintain
or restore the function of the device without changing its perf ormance
or safety characteristics or its intended purpose, shall ensure that the
item does not adversely affect the safety and performance of th e device.
Supporting evidence shall be kept available for the competent a uth
orities of the Member States.
2. An item that is intended specifically to replace a part or
component of a device and that significantly changes the perfor mance
or safety characteristics or the intended purpose of the device shall be
considered to be a device and shall meet the requirements laid down in
this Regulation.
Article 24
Free movement
Except where otherwise provided for in this Regulation, Member States
shall not refuse, prohibit or restrict the making available on the market
or putting into service within their territory of devices which comply
with the requirements of this Regulation. ▼B
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shall be limited to the aspects of the procedure relating to en suring
sterility until the sterile packaging is opened or damaged. The natural
or legal person shall draw up a statement declaring that steril isation has
been carried out in accordance ...
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02017R0745 — EN — 10.01.2025 — 005.001 — 36
CHAPTER III
IDENTIFICATION AND TRACEABILITY OF DEVICES,
REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS,
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE,
EUROPEAN DATABASE ON MEDICAL DEVICES
Article 25
Identification within the supply chain
1. Distributors and importers shall co-operate with manufacture rs or
authorised representatives to achieve an appropriate level of t raceability
of devices.
2. Economic operators shall be able to identify the following t o the
competent authority, for the period referred to in Article 10(8 ):
(a) any economic operator to whom they have directly supplied a
device;
(b) any economic operator who has directly supplied them with a
device;
(c) any health institution or healthcare professional to which they have
directly supplied a device.
Article 26
Medical devices nomenclature
To facilitate the functioning of the European database on medic al
devices (‘Eudamed’) as referred to in Article 33, the Commissio n
shall ensure that an internationally recognised medical devices nomen
clature is available free of charge to manufacturers and other natural or
legal persons required by this Regulation to use that nomenclat ure. The
Commission shall also endeavour to ensure that that nomenclatur e is
available to other stakeholders free of charge, where reasonabl y
practicable.
Article 27
Unique Device Identification system
1. The Unique Device Identification system (‘UDI system’) descr ibed
in Part C of Annex VI shall allow the identification and facili tate the
traceability of devices, other than custom-made and investigati onal
devices, and shall consist of the following:
(a) production of a UDI that comprises the following:
(i) a UDI device identifier (‘UDI-DI’) specific to a manufactur er
and a device, providing access to the information laid down in
Part B of Annex VI; ▼B
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CHAPTER III
IDENTIFICATION AND TRACEABILITY OF DEVICES,
REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS,
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE,
EUROPEAN DATABASE ON MEDICAL DEVICES
Article 25
Identification within the supply chain
1. Di...
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02017R0745 — EN — 10.01.2025 — 005.001 — 37
(ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of
device production and if applicable the packaged devices, as
specified in Part C of Annex VI;
(b) placing of the UDI on the label of the device or on its pac kaging;
(c) storage of the UDI by economic operators, health institutio ns and
healthcare professionals, in accordance with the conditions lai d
down in paragraphs 8 and 9 of this Article respectively;
(d) establishment of an electronic system for Unique Device Ide ntifi
cation (‘UDI database’) in accordance with Article 28.
2. The Commission shall, by means of implementing acts, designa te
one or several entities to operate a system for assignment of U DIs
pursuant to this Regulation (‘issuing entity’). That entity or those
entities shall satisfy all of the following criteria:
(a) the entity is an organisation with legal personality;
(b) its system for the assignment of UDIs is adequate to identi fy a
device throughout its distribution and use in accordance with t he
requirements of this Regulation;
(c) its system for the assignment of UDIs conforms to the relev ant
international standards;
(d) the entity gives access to its system for the assignment of UDIs to
all interested users in accordance with a set of predetermined and
transparent terms and conditions;
(e) the entity undertakes to do the following:
(i) operate its system for the assignment of UDIs for at least 10
years after its designation;
(ii) make available to the Commission and to the Member States,
upon request, information concerning its system for the
assignment of UDIs;
(iii) remain in compliance with the criteria for designation an d the
terms of designation.
When designating issuing entities, the Commission shall endeavo ur to
ensure that UDI carriers, as defined in Part C of Annex VI, are
universally readable regardless of the system used by the issui ng
entity, with a view to minimising financial and administrative burdens
for economic operators and health institutions.
3. Before placing a device, other than a custom-made device, on the
market, the manufacturer shall assign to the device and, if app licable, to
all higher levels of packaging, a UDI created in compliance wit h the
rules of the issuing entity designated by the Commission in acc ordance
with paragraph 2.
Before a device, other than a custom-made or investigational de vice, is
placed on the market the manufacturer shall ensure that the inf ormation
referred to in Part B of Annex VI of the device in question are correctly
submitted and transferred to the UDI database referred to in Ar ticle 28. ▼B
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(ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of
device production and if applicable the packaged devices, as
specified in Part C of Annex VI;
(b) placing of the UDI on the label of the device or on its pac kaging;
(c) stora...
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02017R0745 — EN — 10.01.2025 — 005.001 — 38
4. UDI carriers shall be placed on the label of the device and on all
higher levels of packaging. Higher levels of packaging shall no t be
understood to include shipping containers.
5. The UDI shall be used for reporting serious incidents and fi eld
safety corrective actions in accordance with Article 87.
6. The Basic UDI-DI, as defined in Part C of Annex VI, of the
device shall appear on the EU declaration of conformity referre d to in
Article 19.
7. As part of the technical documentation referred to in Annex II, the
manufacturer shall keep up-to-date a list of all UDIs that it h as assigned.
8. Economic operators shall store and keep, preferably by elect ronic
means, the UDI of the devices which they have supplied or with which
they have been supplied, if those devices belong to:
— class III implantable devices;
— the devices, categories or groups of devices determined by a
measure referred to in point (a) of paragraph 11.
9. Health institutions shall store and keep preferably by elect ronic
means the UDI of the devices which they have supplied or with
which they have been supplied, if those devices belong to class III
implantable devices.
For devices other than class III implantable devices, Member St ates
shall encourage, and may require, health institutions to store and
keep, preferably by electronic means, the UDI of the devices wi th
which they have been supplied.
Member States shall encourage, and may require, healthcare prof es
sionals to store and keep preferably by electronic means, the U DI of
the devices with which they have been supplied with.
10. The Commission is empowered to adopt delegated acts in
accordance with Article 115:
(a) amending the list of information set out in Part B of Annex VI in
the light of technical progress; and
(b) amending Annex VI in the light of international development s and
technical progress in the field of Unique Device Identification .
11. The Commission may, by means of implementing acts, specify
the detailed arrangements and the procedural aspects for the UD I system
with a view to ensuring its harmonised application in relation to any of
the following:
(a) determining the devices, categories or groups of devices to which
the obligation laid down in paragraph 8 is to apply;
(b) specifying the data to be included in the UDI-PI of specifi c devices
or device groups; ▼B
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4. UDI carriers shall be placed on the label of the device and on all
higher levels of packaging. Higher levels of packaging shall no t be
understood to include shipping containers.
5. The UDI shall be used for reporting serious incidents and fi eld ...
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02017R0745 — EN — 10.01.2025 — 005.001 — 39
The implementing acts referred to in the first subparagraph sha ll be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
12. When adopting the measures referred to in paragraph 11, the
Commission shall take into account all of the following:
(a) confidentiality and data protection as referred to in Artic les 109 and
110 respectively;
(b) the risk-based approach;
(c) the cost-effectiveness of the measures;
(d) the convergence of UDI systems developed at international l evel;
(e) the need to avoid duplications in the UDI system;
(f) the needs of the healthcare systems of the Member States, a nd
where possible, compatibility with other medical device identif i
cation systems that are used by stakeholders.
Article 28
UDI database
1. The Commission, after consulting the MDCG shall set up and
manage a UDI database to validate, collate, process and make
available to the public the information mentioned in Part B of
Annex VI.
2. When designing the UDI database, the Commission shall take i nto
account the general principles set out in Section 5 of Part C o f
Annex VI. The UDI database shall be designed in particular such that
no UDI-PIs and no commercially confidential product information can
be included therein.
3. The core data elements to be provided to the UDI database,
referred to in Part B of Annex VI, shall be accessible to the p ublic
free of charge.
4. The technical design of the UDI database shall ensure maximu m
accessibility to information stored therein, including multi-us er access
and automatic uploads and downloads of that information. The
Commission shall provide for technical and administrative suppo rt to
manufacturers and other users of the UDI database.
Article 29
Registration of devices
1. Before placing a device, other than a custom-made device, on the
market, the manufacturer shall, in accordance with the rules of the
issuing entity referred to in Article 27(2), assign a Basic UDI -DI as
defined in Part C of Annex VI to the device and shall provide i t to the
UDI database together with the other core data elements referre d to in
Part B of Annex VI related to that device. ▼B
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The implementing acts referred to in the first subparagraph sha ll be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
12. When adopting the measures referred to in paragraph 11, the
Commission shall take into ac...
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02017R0745 — EN — 10.01.2025 — 005.001 — 40
2. Before placing on the market a system or procedure pack purs uant
to Article 22(1) and (3), that is not a custom-made device, the natural or
legal person responsible shall assign to the system or procedur e pack, in
compliance with the rules of the issuing entity, a Basic UDI-DI and
shall provide it to the UDI database together with the other co re data
elements referred to in Part B of Annex VI related to that syst em or
procedure pack.
3. For devices that are the subject of a conformity assessment as
referred to in Article 52(3) and in the second and third subpar agraphs of
Article 52(4), the assignment of a Basic UDI-DI referred to in
paragraph 1 of this Article shall be done before the manufactur er
applies to a notified body for that assessment.
For the devices referred to in the first subparagraph, the noti fied body
shall include a reference to the Basic UDI-DI on the certificat e issued in
accordance with point (a) of Section 4 of Chapter I of Annex XI I and
confirm in Eudamed that the information referred to in Section 2.2 of
Part A of Annex VI is correct. After the issuing of the relevan t certifi
cate and before placing the device on the market, the manufactu rer shall
provide the Basic UDI-DI to the UDI database together with the other
core data elements referred to in Part B of Annex VI related to that
device.
4. Before placing a device on the market, other than a custom-m ade
device, the manufacturer shall enter or if, already provided, v erify in
Eudamed the information referred to in Section 2 of Part A of
Annex VI, with the exception of Section 2.2 thereof, and shall thereafter
keep the information updated.
Article 30
Electronic system for registration of economic operators
1. The Commission, after consulting the MDCG, shall set up and
manage an electronic system to create the single registration n umber
referred to in Article 31(2) and to collate and process informa tion that is
necessary and proportionate to identify the manufacturer and, w here
applicable, the authorised representative and the importer. The details
regarding the information to be provided to that electronic sys tem by the
economic operators are laid down in Section 1 of Part A of Anne x VI.
2. Member States may maintain or introduce national provisions on
registration of distributors of devices which have been made av ailable
on their territory.
3. Within two weeks of placing a device, other than a custom-ma de
device, on the market, importers shall verify that the manufact urer or
authorised representative has provided to the electronic system the
information referred to in paragraph 1.
Where applicable, importers shall inform the relevant authorise d rep
resentative or manufacturer if the information referred to in p aragraph 1
is not included or is incorrect. Importers shall add their deta ils to the
relevant entry/entries. ▼B
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2. Before placing on the market a system or procedure pack purs uant
to Article 22(1) and (3), that is not a custom-made device, the natural or
legal person responsible shall assign to the system or procedur e pack, in
compliance with the rules of th...
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02017R0745 — EN — 10.01.2025 — 005.001 — 41
Article 31
Registration of manufacturers, authorised representatives and
importers
1. Before placing a device, other than a custom-made device, on the
market, manufacturers, authorised representatives and importers shall, in
order to register, submit to the electronic system referred to in Article 30
the information referred to in Section 1 of Part A of Annex VI,
provided that they have not already registered in accordance wi th this
Article. In cases where the conformity assessment procedure req uires
the involvement of a notified body pursuant to Article 52, the
information referred to in Section 1 of Part A of Annex VI shal l be
provided to that electronic system before applying to the notif ied body.
2. After having verified the data entered pursuant to paragraph 1, the
competent authority shall obtain a single registration number ( ‘SRN’)
from the electronic system referred to in Article 30 and issue it to the
manufacturer, the authorised representative or the importer.
3. The manufacturer shall use the SRN when applying to a notifi ed
body for conformity assessment and for accessing Eudamed in ord er to
fulfil its obligations under Article 29.
4. Within one week of any change occurring in relation to the
information referred to in paragraph 1 of this Article, the eco nomic
operator shall update the data in the electronic system referre d to in
Article 30.
5. Not later than one year after submission of the information in
accordance with paragraph 1, and every second year thereafter, the
economic operator shall confirm the accuracy of the data. In th e
event of a failure to do so within six months of those deadline s, any
Member State may take appropriate corrective measures within it s
territory until that economic operator complies with that oblig ation.
6. Without prejudice to the economic operator's responsibility for the
data, the competent authority shall verify the confirmed data r eferred to
in Section 1 of Part A of Annex VI.
7. The data entered pursuant to paragraph 1 of this Article in the
electronic system referred to in Article 30 shall be accessible to the
public.
8. The competent authority may use the data to charge the manu
facturer, the authorised representative or the importer a fee p ursuant to
Article 111.
Article 32
Summary of safety and clinical performance
1. For implantable devices and for class III devices, other tha n
custom-made or investigational devices, the manufacturer shall draw
up a summary of safety and clinical performance. ▼B
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Article 31
Registration of manufacturers, authorised representatives and
importers
1. Before placing a device, other than a custom-made device, on the
market, manufacturers, authorised representatives and importers shall, in
order to register, s...
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02017R0745 — EN — 10.01.2025 — 005.001 — 42
The summary of safety and clinical performance shall be written in a
way that is clear to the intended user and, if relevant, to the patient and
shall be made available to the public via Eudamed.
The draft of the summary of safety and clinical performance sha ll be
part of the documentation to be submitted to the notified body involved
in the conformity assessment pursuant to Article 52 and shall b e
validated by that body. After its validation, the notified body shall
upload the summary to Eudamed. The manufacturer shall mention o n
the label or instructions for use where the summary is availabl e.
2. The summary of safety and clinical performance shall include at
least the following aspects:
(a) the identification of the device and the manufacturer, incl uding the
Basic UDI-DI and, if already issued, the SRN;
(b) the intended purpose of the device and any indications, con traindi
cations and target populations;
(c) a description of the device, including a reference to previ ous
generation(s) or variants if such exist, and a description of t he
differences, as well as, where relevant, a description of any
accessories, other devices and products, which are intended to be
used in combination with the device;
(d) possible diagnostic or therapeutic alternatives;
(e) reference to any harmonised standards and CS applied;
(f) the summary of clinical evaluation as referred to in Annex XIV, and
relevant information on post-market clinical follow-up;
(g) suggested profile and training for users;
(h) information on any residual risks and any undesirable effec ts,
warnings and precautions.
3. The Commission may, by means of implementing acts, set out t he
form and the presentation of the data elements to be included i n the
summary of safety and clinical performance. Those implementing acts
shall be adopted in accordance with the advisory procedure refe rred to
in Article 114(2).
Article 33
European database on medical devices
1. The Commission, after consulting the MDCG, shall set up,
maintain and manage the European database on medical devices
(‘Eudamed’) for the following purposes:
(a) to enable the public to be adequately informed about device s placed
on the market, the corresponding certificates issued by notifie d
bodies and about the relevant economic operators; ▼B
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The summary of safety and clinical performance shall be written in a
way that is clear to the intended user and, if relevant, to the patient and
shall be made available to the public via Eudamed.
The draft of the summary of safety and clinical perf...
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02017R0745 — EN — 10.01.2025 — 005.001 — 43
(b) to enable unique identification of devices within the inter nal market
and to facilitate their traceability;
(c) to enable the public to be adequately informed about clinic al inves
tigations and to enable sponsors of clinical investigations to comply
with obligations under Articles 62 to 80, Article 82, and any a cts
adopted pursuant to Article 81;
(d) to enable manufacturers to comply with the information obli gations
laid down in Articles 87 to 90 or in any acts adopted pursuant to
Article 91;
(e) to enable the competent authorities of the Member States an d the
Commission to carry out their tasks relating to this Regulation on
a well-informed basis and to enhance the cooperation between th em.
2. Eudamed shall include the following electronic systems:
(a) the electronic system for registration of devices referred to in
Article 29(4);
(b) the UDI-database referred to in Article 28;
(c) the electronic system on registration of economic operators referred
to in Article 30;
(d) the electronic system on notified bodies and on certificate s referred
to in Article 57;
(e) the electronic system on clinical investigations referred t o in
Article 73;
(f) the electronic system on vigilance and post-market surveill ance
referred to in Article 92;
(g) the electronic system on market surveillance referred to in
Article 100.
3. When designing Eudamed the Commission shall give due con
sideration to compatibility with national databases and nationa l
web-interfaces to allow for import and export of data.
4. The data shall be entered into Eudamed by the Member States,
notified bodies, economic operators and sponsors as specified i n the
provisions on the electronic systems referred to in paragraph 2 . The
Commission shall provide for technical and administrative suppo rt to
users of Eudamed.
5. All the information collated and processed by Eudamed shall be
accessible to the Member States and to the Commission. The
information shall be accessible to notified bodies, economic op erators,
sponsors and the public to the extent specified in the provisio ns on the
electronic systems referred to in paragraph 2.
The Commission shall ensure that public parts of Eudamed are
presented in a user-friendly and easily-searchable format. ▼B
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(b) to enable unique identification of devices within the inter nal market
and to facilitate their traceability;
(c) to enable the public to be adequately informed about clinic al inves
tigations and to enable sponsors of clinical investigations to c...
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02017R0745 — EN — 10.01.2025 — 005.001 — 44
6. Eudamed shall contain personal data only insofar as necessar y for
the electronic systems referred to in paragraph 2 of this Artic le to collate
and process information in accordance with this Regulation. Per sonal
data shall be kept in a form which permits identification of da ta subjects
for periods no longer than those referred to in Article 10(8).
7. The Commission and the Member States shall ensure that data
subjects may effectively exercise their rights to information, of access,
to rectification and to object in accordance with Regu
lation (EC) No 45/2001 and Directive 95/46/EC, respectively. Th ey
shall also ensure that data subjects may effectively exercise t he right
of access to data relating to them, and the right to have inacc urate or
incomplete data corrected and erased. Within their respective r esponsi
bilities, the Commission and the Member States shall ensure tha t inac
curate and unlawfully processed data are deleted, in accordance with the
applicable legislation. Corrections and deletions shall be carr ied out as
soon as possible, but no later than 60 days after a request is made by a
data subject.
8. The Commission shall, by means of implementing acts, lay dow n
the detailed arrangements necessary for the setting up and main tenance
of Eudamed. Those implementing acts shall be adopted in accorda nce
with the examination procedure referred to in Article 114(3). W hen
adopting those implementing acts, the Commission shall ensure t hat,
as far as possible, the system is developed in such a way as to avoid
having to enter the same information twice within the same modu le or
in different modules of the system.
9. In relation to its responsibilities under this Article and t he
processing of personal data involved therein, the Commission sh all be
considered to be the controller of Eudamed and its electronic s ystems.
Article 34
Functionality of Eudamed
▼M5
1. The Commission shall, in collaboration with the MDCG, draw u p
the functional specifications for Eudamed. The Commission shall draw
up a plan for the implementation of those specifications by 26 May
2018.
2. The Commission shall inform the MDCG when, on the basis of
independent audit reports, it has verified that one or more of the elec
tronic systems referred to in Article 33(2) are functional and meet the
functional specifications drawn up pursuant to paragraph 1 of t his
Article.
▼B
3. The Commission shall, after consultation with the MDCG and
when it is satisfied that the conditions referred to in paragra ph 2 have
been fulfilled, publish a notice to that effect in the Official Journal of
the European Union . ▼B
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6. Eudamed shall contain personal data only insofar as necessar y for
the electronic systems referred to in paragraph 2 of this Artic le to collate
and process information in accordance with this Regulation. Per sonal
data shall be kept in a form whic...
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02017R0745 — EN — 10.01.2025 — 005.001 — 45
CHAPTER IV
NOTIFIED BODIES
Article 35
Authorities responsible for notified bodies
1. Any Member State that intends to designate a conformity
assessment body as a notified body, or has designated a notifie d
body, to carry out conformity assessment activities under this Regu
lation shall appoint an authority (‘authority responsible for n otified
bodies’), which may consist of separate constituent entities un der
national law and shall be responsible for setting up and carryi ng out
the necessary procedures for the assessment, designation and no tifi
cation of conformity assessment bodies and for the monitoring o f
notified bodies, including subcontractors and subsidiaries of t hose
bodies.
2. The authority responsible for notified bodies shall be estab lished,
organised and operated so as to safeguard the objectivity and i mpar
tiality of its activities and to avoid any conflicts of interes ts with
conformity assessment bodies.
3. The authority responsible for notified bodies shall be organ ised in
a manner such that each decision relating to designation or not ification
is taken by personnel different from those who carried out the
assessment.
4. The authority responsible for notified bodies shall not perf orm any
activities that notified bodies perform on a commercial or comp etitive
basis.
5. The authority responsible for notified bodies shall safeguar d the
confidential aspects of the information it obtains. However, it shall
exchange information on notified bodies with other Member State s,
the Commission and, when required, with other regulatory author ities.
6. The authority responsible for notified bodies shall have a s ufficient
number of competent personnel permanently available for the pro per
performance of its tasks.
Where the authority responsible for notified bodies is a differ ent
authority from the national competent authority for medical dev ices, it
shall ensure that the national authority responsible for medica l devices is
consulted on relevant matters.
7. Member States shall make publicly available general informat ion
on their measures governing the assessment, designation and not ification
of conformity assessment bodies and for the monitoring of notif ied
bodies, and on changes which have a significant impact on such tasks.
8. The authority responsible for notified bodies shall particip ate in
the peer-review activities provided for in Article 48. ▼B
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CHAPTER IV
NOTIFIED BODIES
Article 35
Authorities responsible for notified bodies
1. Any Member State that intends to designate a conformity
assessment body as a notified body, or has designated a notifie d
body, to carry out conformity assessm...
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02017R0745 — EN — 10.01.2025 — 005.001 — 46
Article 36
Requirements relating to notified bodies
1. Notified bodies shall fulfil the tasks for which they are de signated
in accordance with this Regulation. They shall satisfy the orga nisational
and general requirements and the quality management, resource a nd
process requirements that are necessary to fulfil those tasks. In
particular, notified bodies shall comply with Annex VII.
In order to meet the requirements referred to in the first subp aragraph,
notified bodies shall have permanent availability of sufficient adminis
trative, technical and scientific personnel in accordance with
Section 3.1.1 of Annex VII and personnel with relevant clinical
expertise in accordance with Section 3.2.4 of Annex VII, where
possible employed by the notified body itself.
The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall
be employed by the notified body itself and shall not be extern al experts
or subcontractors.
2. Notified bodies shall make available and submit upon request all
relevant documentation, including the manufacturer's documentat ion, to
the authority responsible for notified bodies to allow it to co nduct its
assessment, designation, notification, monitoring and surveilla nce
activities and to facilitate the assessment outlined in this Ch apter.
3. In order to ensure the uniform application of the requiremen ts set
out in Annex VII, the Commission may adopt implementing acts, t o the
extent necessary to resolve issues of divergent interpretation and of
practical application. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Articl e 114(3).
Article 37
Subsidiaries and subcontracting
1. Where a notified body subcontracts specific tasks connected with
conformity assessment or has recourse to a subsidiary for speci fic tasks
connected with conformity assessment, it shall verify that the subcon
tractor or the subsidiary meets the applicable requirements set out in
Annex VII and shall inform the authority responsible for notifi ed bodies
accordingly.
2. Notified bodies shall take full responsibility for the tasks
performed on their behalf by subcontractors or subsidiaries.
3. Notified bodies shall make publicly available a list of thei r
subsidiaries.
4. Conformity assessment activities may be subcontracted or car ried
out by a subsidiary provided that the legal or natural person t hat applied
for conformity assessment has been informed accordingly. ▼B
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Article 36
Requirements relating to notified bodies
1. Notified bodies shall fulfil the tasks for which they are de signated
in accordance with this Regulation. They shall satisfy the orga nisational
and general requirements and the quality managem...
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02017R0745 — EN — 10.01.2025 — 005.001 — 47
5. Notified bodies shall keep at the disposal of the authority
responsible for notified bodies all relevant documents concerni ng the
verification of the qualifications of the subcontractor or the subsidiary
and the work carried out by them under this Regulation.
Article 38
Application by conformity assessment bodies for designation
1. Conformity assessment bodies shall submit an application for
designation to the authority responsible for notified bodies.
2. The application shall specify the conformity assessment acti vities
as defined in this Regulation, and the types of devices for whi ch the
body is applying to be designated, and shall be supported by do cumen
tation demonstrating compliance with Annex VII.
In respect of the organisational and general requirements and t he quality
management requirements set out in Sections 1 and 2 of Annex VI I, a
valid accreditation certificate and the corresponding evaluatio n report
delivered by a national accreditation body in accordance with R egu
lation (EC) No 765/2008 may be submitted and shall be taken int o
consideration during the assessment described in Article 39. Ho wever,
the applicant shall make available all the documentation referr ed to in
the first subparagraph to demonstrate compliance with those
requirements upon request.
3. The notified body shall update the documentation referred to in
paragraph 2 whenever relevant changes occur, in order to enable the
authority responsible for notified bodies to monitor and verify
continuous compliance with all the requirements set out in Anne x VII.
Article 39
Assessment of the application
1. The authority responsible for notified bodies shall within 3 0 days
check that the application referred to in Article 38 is complet e and shall
request the applicant to provide any missing information. Once the
application is complete that authority shall send it to the Com mission.
The authority responsible for notified bodies shall review the application
and supporting documentation in accordance with its own procedu res
and shall draw up a preliminary assessment report.
2. The authority responsible for notified bodies shall submit t he
preliminary assessment report to the Commission which shall imm edi
ately transmit it to the MDCG.
3. Within 14 days of the submission referred to in paragraph 2 of this
Article, the Commission, in conjunction with the MDCG, shall ap point
a joint assessment team made up of three experts, unless the sp ecific
circumstances require a different number of experts, chosen fro m the list
referred to in Article 40(2). One of the experts shall be a rep resentative
of the Commission who shall coordinate the activities of the jo int
assessment team. The other two experts shall come from Member S tates
other than the one in which the applicant conformity assessment body is
established. ▼B
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5. Notified bodies shall keep at the disposal of the authority
responsible for notified bodies all relevant documents concerni ng the
verification of the qualifications of the subcontractor or the subsidiary
and the work carried out by them under this...
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02017R0745 — EN — 10.01.2025 — 005.001 — 48
The joint assessment team shall be comprised of experts who are
competent to assess the conformity assessment activities and th e types
of devices which are the subject of the application or, in part icular when
the assessment procedure is initiated in accordance with Articl e 47(3),
to ensure that the specific concern can be appropriately assess ed.
4. Within 90 days of its appointment, the joint assessment team shall
review the documentation submitted with the application in acco rdance
with Article 38. The joint assessment team may provide feedback to, or
require clarification from, the authority responsible for notif ied bodies
on the application and on the planned on-site assessment.
The authority responsible for notified bodies together with the joint
assessment team shall plan and conduct an on-site assessment of the
applicant conformity assessment body and, where relevant, of an y
subsidiary or subcontractor, located inside or outside the Unio n, to be
involved in the conformity assessment process.
The on-site assessment of the applicant body shall be led by th e
authority responsible for notified bodies.
5. Findings regarding non-compliance of an applicant conformity
assessment body with the requirements set out in Annex VII shal l be
raised during the assessment process and discussed between the
authority responsible for notified bodies and the joint assessm ent team
with a view to reaching consensus and resolving any diverging
opinions, with respect to the assessment of the application.
At the end of the on-site assessment, the authority responsible for
notified bodies shall list for the applicant conformity assessm ent body
the non-compliances resulting from the assessment and summarise the
assessment by the joint assessment team.
Within a specified timeframe, the applicant conformity assessme nt body
shall submit to the national authority a corrective and prevent ive action
plan to address the non-compliances.
6. The joint assessment team shall document any remaining
diverging opinions with respect to the assessment within 30 day s of
completion of the on-site assessment and send them to the autho rity
responsible for notified bodies.
7. The authority responsible for notified bodies shall followin g
receipt of a corrective and preventive action plan from the app licant
body assess whether non-compliances identified during the asses sment
have been appropriately addressed. This plan shall indicate the root
cause of the identified non-compliances and shall include a tim eframe
for implementation of the actions therein.
The authority responsible for notified bodies shall having conf irmed the
corrective and preventive action plan forward it and its opinio n thereon
to the joint assessment team. The joint assessment team may req uest of
the authority responsible for notified bodies further clarifica tion and
modifications.
The authority responsible for notified bodies shall draw up its final
assessment report which shall include: ▼B
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The joint assessment team shall be comprised of experts who are
competent to assess the conformity assessment activities and th e types
of devices which are the subject of the application or, in part icular when
the assessment procedure is initiated ...
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02017R0745 — EN — 10.01.2025 — 005.001 — 49
— the result of the assessment,
— confirmation that the corrective and preventive actions have been
appropriately addressed and, where required, implemented,
— any remaining diverging opinion with the joint assessment tea m,
and, where applicable,
— the recommended scope of designation.
8. The authority responsible for notified bodies shall submit i ts final
assessment report and, if applicable, the draft designation to the
Commission, the MDCG and the joint assessment team.
9. The joint assessment team shall provide a final opinion rega rding
the assessment report prepared by the authority responsible for notified
bodies and, if applicable, the draft designation within 21 days of receipt
of those documents to the Commission, which shall immediately s ubmit
that final opinion to the MDCG. Within 42 days of receipt of th e
opinion of the joint assessment team, the MDCG shall issue a re com
mendation with regard to the draft designation, which the autho rity
responsible for notified bodies shall duly take into considerat ion for
its decision on the designation of the notified body.
10. The Commission may, by means of implementing acts, adopt
measures setting out the detailed arrangements specifying proce dures
and reports for the application for designation referred to in Article 38
and the assessment of the application set out in this Article. Those
implementing acts shall be adopted in accordance with the exami nation
procedure referred to in Article 114(3).
Article 40
Nomination of experts for joint assessment of applications for
notification
1. The Member States and the Commission shall nominate experts
qualified in the assessment of conformity assessment bodies in the field
of medical devices to participate in the activities referred to in
Articles 39 and 48.
2. The Commission shall maintain a list of the experts nominate d
pursuant to paragraph 1 of this Article, together with informat ion on
their specific field of competence and expertise. That list sha ll be made
available to Member States competent authorities through the el ectronic
system referred to in Article 57.
Article 41
Language requirements
All documents required pursuant to Articles 38 and 39 shall be drawn
up in a language or languages which shall be determined by the
Member State concerned.
Member States, in applying the first paragraph, shall consider accepting
and using a commonly understood language in the medical field, for all
or part of the documentation concerned. ▼B
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— the result of the assessment,
— confirmation that the corrective and preventive actions have been
appropriately addressed and, where required, implemented,
— any remaining diverging opinion with the joint assessment tea m,
and, where applicable, ...
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02017R0745 — EN — 10.01.2025 — 005.001 — 50
The Commission shall provide translations of the documentation
pursuant to Articles 38 and 39, or parts thereof into an offici al Union
language, such as is necessary for that documentation to be rea dily
understood by the joint assessment team appointed in accordance with
Article 39(3).
Article 42
Designation and notification procedure
1. Member States may only designate conformity assessment bodie s
for which the assessment pursuant to Article 39 was completed a nd
which comply with Annex VII.
2. Member States shall notify the Commission and the other
Member States of the conformity assessment bodies they have
designated, using the electronic notification tool within the d atabase
of notified bodies developed and managed by the Commission
(NANDO).
3. The notification shall clearly specify, using the codes refe rred to in
paragraph 13 of this Article, the scope of the designation indi cating the
conformity assessment activities as defined in this Regulation and the
types of devices which the notified body is authorised to asses s and,
without prejudice to Article 44, any conditions associated with the
designation.
4. The notification shall be accompanied by the final assessmen t
report of the authority responsible for notified bodies, the fi nal
opinion of the joint assessment team referred to in Article 39( 9) and
the recommendation of the MDCG. Where the notifying Member Stat e
does not follow the recommendation of the MDCG, it shall provid e a
duly substantiated justification.
5. The notifying Member State shall, without prejudice to Artic le 44,
inform the Commission and the other Member States of any condit ions
associated with the designation and provide documentary evidenc e
regarding the arrangements in place to ensure that the notified body
will be monitored regularly and will continue to satisfy the re quirements
set out in Annex VII.
6. Within 28 days of the notification referred to in paragraph 2,
a Member State or the Commission may raise written objections,
setting out its arguments, with regard either to the notified b ody or to
its monitoring by the authority responsible for notified bodies . Where no
objection is raised, the Commission shall publish in NANDO the notifi
cation within 42 days of its having been notified as referred t o in
paragraph 2.
7. When a Member State or the Commission raises objections in
accordance with paragraph 6, the Commission shall bring the mat ter
before the MDCG within 10 days of the expiry of the period refe rred to
in paragraph 6. After consulting the parties involved, the MDCG shall
give its opinion at the latest within 40 days of the matter hav ing been
brought before it. Where the MDCG is of the opinion that the no tifi
cation can be accepted, the Commission shall publish in NANDO t he
notification within 14 days. ▼B
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The Commission shall provide translations of the documentation
pursuant to Articles 38 and 39, or parts thereof into an offici al Union
language, such as is necessary for that documentation to be rea dily
understood by the joint assessment team appoin...
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02017R0745 — EN — 10.01.2025 — 005.001 — 51
8. Where the MDCG, after having been consulted in accordance wi th
paragraph 7, confirms the existing objection or raises another objection,
the notifying Member State shall provide a written response to the
MDCG opinion within 40 days of its receipt. The response shall
address the objections raised in the opinion, and set out the r easons
for the notifying Member State's decision to designate or not d esignate
the conformity assessment body.
9. Where the notifying Member State decides to uphold its decis ion
to designate the conformity assessment body, having given its r easons
in accordance with paragraph 8, the Commission shall publish in
NANDO the notification within 14 days of being informed thereof .
10. When publishing the notification in NANDO, the Commission
shall also add to the electronic system referred to in Article 57 the
information relating to the notification of the notified body a long with
the documents mentioned in paragraph 4 of this Article and the opinion
and responses referred to in paragraphs 7 and 8 of this Article .
11. The designation shall become valid the day after the notifi cation
is published in NANDO. The published notification shall state t he scope
of lawful conformity assessment activity of the notified body.
12. The conformity assessment body concerned may perform the
activities of a notified body only after the designation has be come
valid in accordance with paragraph 11.
13. The Commission shall by 26 November 2017, by means of im
plementing acts, draw up a list of codes and corresponding type s of
devices for the purpose of specifying the scope of the designat ion of
notified bodies. Those implementing acts shall be adopted in ac cordance
with the examination procedure referred to in Article 114(3). T he
Commission, after consulting the MDCG, may update this list bas ed,
inter alia , on information arising from the coordination activities
described in Article 48.
Article 43
Identification number and list of notified bodies
1. The Commission shall assign an identification number to each
notified body for which the notification becomes valid in accor dance
with Article 42(11). It shall assign a single identification nu mber even
when the body is notified under several Union acts. If they are
successfully designated in accordance with this Regulation, bod ies
notified pursuant to Directives 90/385/EEC and 93/42/EEC shall
retain the identification number assigned to them pursuant to t hose
Directives.
2. The Commission shall make the list of the bodies notified un der
this Regulation, including the identification numbers that have been
assigned to them and the conformity assessment activities as de fined
in this Regulation and the types of devices for which they have been
notified, accessible to the public in NANDO. It shall also make this list
available on the electronic system referred to in Article 57. T he
Commission shall ensure that the list is kept up to date. ▼B
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8. Where the MDCG, after having been consulted in accordance wi th
paragraph 7, confirms the existing objection or raises another objection,
the notifying Member State shall provide a written response to the
MDCG opinion within 40 days of its receipt....
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02017R0745 — EN — 10.01.2025 — 005.001 — 52
Article 44
Monitoring and re-assessment of notified bodies
1. Notified bodies shall, without delay, and at the latest with in 15
days, inform the authority responsible for notified bodies of r elevant
changes which may affect their compliance with the requirements set
out in Annex VII or their ability to conduct the conformity ass essment
activities relating to the devices for which they have been des ignated.
2. The authorities responsible for notified bodies shall monito r the
notified bodies established on their territory and their subsid iaries and
subcontractors to ensure ongoing compliance with the requiremen ts and
the fulfilment of its obligations set out in this Regulation. N otified
bodies shall, upon request by their authority responsible for n otified
bodies, supply all relevant information and documents, required to
enable the authority, the Commission and other Member States to
verify compliance.
3. Where the Commission or the authority of a Member State
submits a request to a notified body established on the territo ry of
another Member State relating to a conformity assessment carrie d out
by that notified body, it shall send a copy of that request to the authority
responsible for notified bodies of that other Member State. The notified
body concerned shall respond without delay and within 15 days a t the
latest to the request. The authority responsible for notified b odies of the
Member State in which the body is established shall ensure that requests
submitted by authorities of any other Member State or by the
Commission are resolved by the notified body unless there is a
legitimate reason for not doing so in which case the matter may be
referred to the MDCG.
4. At least once a year, the authorities responsible for notifi ed bodies
shall re-assess whether the notified bodies established on thei r respective
territory and, where appropriate, the subsidiaries and subcontr actors
under the responsibility of those notified bodies still satisfy the
requirements and fulfil their obligations set out in Annex VII. That
review shall include an on-site audit of each notified body and , where
necessary, of its subsidiaries and subcontractors.
The authority responsible for notified bodies shall conduct its moni
toring and assessment activities according to an annual assessm ent
plan to ensure that it can effectively monitor the continued co mpliance
of the notified body with the requirements of this Regulation. That plan
shall provide a reasoned schedule for the frequency of assessme nt of the
notified body and, in particular, associated subsidiaries and s ubcon
tractors. The authority shall submit its annual plan for monito ring or
assessment for each notified body for which it is responsible t o the
MDCG and to the Commission.
5. The monitoring of notified bodies by the authority responsib le for
notified bodies shall include observed audits of notified body personnel,
including where necessary any personnel from subsidiaries and s ubcon
tractors, as that personnel is in the process of conducting qua lity
management system assessments at a manufacturer's facility. ▼B
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Article 44
Monitoring and re-assessment of notified bodies
1. Notified bodies shall, without delay, and at the latest with in 15
days, inform the authority responsible for notified bodies of r elevant
changes which may affect their compliance with ...
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02017R0745 — EN — 10.01.2025 — 005.001 — 53
6. The monitoring of notified bodies conducted by the authority
responsible for notified bodies shall consider data arising fro m market
surveillance, vigilance and post-market surveillance to help gu ide its
activities.
The authority responsible for notified bodies shall provide for a
systematic follow-up of complaints and other information, inclu ding
from other Member States, which may indicate non-fulfilment of the
obligations by a notified body or its deviation from common or best
practice.
7. The authority responsible for notified bodies may in additio n to
regular monitoring or on-site assessments conduct short-notice, unan
nounced or ‘for-cause’ reviews if needed to address a particula r issue or
to verify compliance.
8. The authority responsible for notified bodies shall review t he
assessments by notified bodies of manufacturers' technical docu men
tation, in particular the clinical evaluation documentation as further
outlined in Article 45.
9. The authority responsible for notified bodies shall document and
record any findings regarding non-compliance of the notified bo dy with
the requirements set out in Annex VII and shall monitor the tim ely
implementation of corrective and preventive actions.
▼M2
10. 5 years after notification of a notified body, and again ev ery 5
years thereafter, a complete re-assessment to determine whether the
notified body still satisfies the requirements set out in Annex VII
shall be conducted by the authority responsible for notified bo dies of
the Member State in which the body is established and by a join t
assessment team in accordance with the procedure described in
Article 39.
The authority responsible for notified bodies of the Member Sta te in
which the notified body is established may conduct a complete
re-assessment prior to the dates referred to in the first subpa ragraph,
upon request by the notified body or where, based on the result s of the
annual assessments conducted in accordance with paragraph 4 of this
Article, it has concerns regarding the continued fulfilment by the
notified body of the requirements set out in Annex VII.
Complete re-assessments that have already started prior to 11 M arch
2023 shall continue to be conducted, unless the authority respo nsible for
notified bodies of the Member State in which the notified body is
established decides to suspend or terminate the ongoing complet e
re-assessment, taking into account its own resources and the re sources
of the notified body already spent on the re-assessment, as wel l as the
results of the annual assessments conducted in accordance with
paragraph 4 of this Article. Before suspending or terminating a n
ongoing complete re-assessment, the authority responsible for n otified
bodies shall hear the notified body concerned. ▼B
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6. The monitoring of notified bodies conducted by the authority
responsible for notified bodies shall consider data arising fro m market
surveillance, vigilance and post-market surveillance to help gu ide its
activities.
The authority responsible f...
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02017R0745 — EN — 10.01.2025 — 005.001 — 54
11. The Commission is empowered to adopt delegated acts in
accordance with Article 115 in order to amend paragraph 10 to
modify the frequency at which the complete re-assessment referr ed to
in that paragraph is to be carried out.
12. The Member States shall report to the Commission and to the
MDCG, at least once a year, on their monitoring and on-site ass essment
activities regarding notified bodies and, where applicable, sub sidiaries
and subcontractors. The report shall provide details of the out come of
those activities, including activities pursuant to paragraph 7, and shall
be treated as confidential by the MDCG and the Commission; howe ver
it shall contain a summary which shall be made publicly availab le.
The summary of the report shall be uploaded to the electronic s ystem
referred to in Article 57.
Article 45
Review of notified body assessment of technical documentation and
clinical evaluation documentation
1. The authority responsible for notified bodies, as part of it s ongoing
monitoring of notified bodies, shall review an appropriate numb er of
notified body assessments of manufacturers' technical documenta tion, in
particular the clinical evaluation documentation as referred to in points
(c) and (d) of Section 6.1 of Annex II to verify the conclusion s drawn
by the notified body based on the information presented by the manu
facturer. The reviews by the authority responsible for notified bodies
shall be conducted both off-site and on-site.
2. The sampling of files to be reviewed in accordance with
paragraph 1 shall be planned and representative of the types an d risk
of devices certified by the notified body, in particular high-r isk devices,
and be appropriately justified and documented in a sampling pla n,
which shall be made available by the authority responsible for
notified bodies to the MDCG upon request.
3. The authority responsible for notified bodies shall review w hether
the assessment by the notified body was conducted appropriately and
shall check the procedures used, associated documentation and t he
conclusions drawn by the notified body. Such checking shall inc lude
the technical documentation and clinical evaluation documentati on of
the manufacturer upon which the notified body has based its
assessment. Such reviews shall be conducted utilising CS.
4. Those reviews shall also form part of the re-assessment of n otified
bodies in accordance with Article 44(10) and the joint assessme nt
activities referred to in Article 47(3). The reviews shall be c onducted
utilising appropriate expertise. ▼B
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11. The Commission is empowered to adopt delegated acts in
accordance with Article 115 in order to amend paragraph 10 to
modify the frequency at which the complete re-assessment referr ed to
in that paragraph is to be carried out.
12. The Member Sta...
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5. Based on the reports of the reviews and assessments by the
authority responsible for notified bodies or joint assessment t eams, on
input from the market surveillance, vigilance and post-market
surveillance activities described in Chapter VII, on the contin uous moni
toring of technical progress, or on the identification of conce rns and
emerging issues concerning the safety and performance of device s, the
MDCG may recommend that the sampling, carried out under this
Article, cover a greater or lesser proportion of the technical documen
tation and clinical evaluation documentation assessed by a noti fied
body.
6. The Commission may, by means of implementing acts, adopt
measures setting out the detailed arrangements, associated docu ments
for, and coordination of, the review of assessments of technica l docu
mentation and clinical evaluation documentation, as referred to in this
Article. Those implementing acts shall be adopted in accordance with
the examination procedure referred to in Article 114(3).
Article 46
Changes to designations and notifications
1. The authority responsible for notified bodies shall notify t he
Commission and the other Member States of any relevant changes to
the designation of a notified body.
The procedures described in Article 39 and in Article 42 shall apply to
extensions of the scope of the designation.
For changes to the designation other than extensions of its sco pe, the
procedures laid down in the following paragraphs shall apply.
2. The Commission shall immediately publish the amended notifi
cation in NANDO. The Commission shall immediately enter
information on the changes to the designation of the notified b ody in
the electronic system referred to in Article 57.
3. Where a notified body decides to cease its conformity assess ment
activities it shall inform the authority responsible for notifi ed bodies and
the manufacturers concerned as soon as possible and in the case of a
planned cessation one year before ceasing its activities. The c ertificates
may remain valid for a temporary period of nine months after ce ssation
of the notified body's activities on condition that another not ified body
has confirmed in writing that it will assume responsibilities f or the
devices covered by those certificates. The new notified body sh all
complete a full assessment of the devices affected by the end o f that
period before issuing new certificates for those devices. Where the
notified body has ceased its activity, the authority responsibl e for
notified bodies shall withdraw the designation.
4. Where a authority responsible for notified bodies has ascert ained
that a notified body no longer meets the requirements set out i n
Annex VII, or that it is failing to fulfil its obligations or h as not im
plemented the necessary corrective measures, the authority shal l
suspend, restrict, or fully or partially withdraw the designati on,
depending on the seriousness of the failure to meet those requi rements
or fulfil those obligations. A suspension shall not exceed a pe riod of
one year, renewable once for the same period. ▼B
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5. Based on the reports of the reviews and assessments by the
authority responsible for notified bodies or joint assessment t eams, on
input from the market surveillance, vigilance and post-market
surveillance activities described in Chapter VII, on t...
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The authority responsible for notified bodies shall immediately inform
the Commission and the other Member States of any suspension,
restriction or withdrawal of a designation.
5. Where its designation has been suspended, restricted, or ful ly or
partially withdrawn, the notified body shall inform the manufac turers
concerned at the latest within 10 days.
6. In the event of restriction, suspension or withdrawal of a d esig
nation, the authority responsible for notified bodies shall tak e appro
priate steps to ensure that the files of the notified body conc erned are
kept and make them available to authorities in other Member Sta tes
responsible for notified bodies and to authorities responsible for
market surveillance at their request.
7. In the event of restriction, suspension or withdrawal of a d esig
nation, the authority responsible for notified bodies shall:
(a) assess the impact on the certificates issued by the notifie d body;
(b) submit a report on its findings to the Commission and the o ther
Member States within three months of having notified the change s
to the designation;
(c) require the notified body to suspend or withdraw, within a
reasonable period of time determined by the authority, any
certificates which were unduly issued to ensure the safety of
devices on the market;
(d) enter into the electronic system referred to in Article 57 information
in relation to certificates of which it has required their susp ension or
withdrawal;
(e) inform the competent authority for medical devices of the
Member State in which the manufacturer has its registered place
of business through the electronic system referred to in Articl e 57 of
the certificates for which it has required suspension or withdr awal.
That competent authority shall take the appropriate measures, w here
necessary to avoid a potential risk to the health or safety of patients,
users or others.
8. With the exception of certificates unduly issued, and where a
designation has been suspended or restricted, the certificates shall
remain valid in the following circumstances:
(a) the authority responsible for notified bodies has confirmed , within
one month of the suspension or restriction, that there is no sa fety
issue in relation to certificates affected by the suspension or
restriction, and the authority responsible for notified bodies has
outlined a timeline and actions anticipated to remedy the suspe nsion
or restriction; or ▼B
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The authority responsible for notified bodies shall immediately inform
the Commission and the other Member States of any suspension,
restriction or withdrawal of a designation.
5. Where its designation has been suspended, restricted, or ful ly or
p...
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(b) the authority responsible for notified bodies has confirmed that no
certificates relevant to the suspension will be issued, amended or
re-issued during the course of the suspension or restriction, a nd
states whether the notified body has the capability of continui ng
to monitor and remain responsible for existing certificates iss ued
for the period of the suspension or restriction. In the event t hat
the authority responsible for notified bodies determines that t he
notified body does not have the capability to support existing
certificates issued, the manufacturer shall provide, to the
competent authority for medical devices of the Member State in
which the manufacturer of the device covered by the certificate
has its registered place of business, within three months of th e
suspension or restriction, a written confirmation that another
qualified notified body is temporarily assuming the functions o f
the notified body to monitor and remain responsible for the
certificates during the period of suspension or restriction.
9. With the exception of certificates unduly issued, and where a
designation has been withdrawn, the certificates shall remain v alid for
a period of nine months in the following circumstances:
(a) where the competent authority for medical devices of the
Member State in which the manufacturer of the device covered
by the certificate has its registered place of business has
confirmed that there is no safety issue associated with the dev ices
in question; and
(b) another notified body has confirmed in writing that it will assume
immediate responsibilities for those devices and will have
completed assessment of them within twelve months of the with
drawal of the designation.
In the circumstances referred to in the first subparagraph, the competent
authority for medical devices of the Member State in which the manu
facturer of the device covered by the certificate has its place of business
may extend the provisional validity of the certificates for fur ther periods
of three months, which altogether shall not exceed twelve month s.
The authority or the notified body assuming the functions of th e notified
body affected by the change of designation shall immediately in form the
Commission, the other Member States and the other notified bodi es
thereof.
Article 47
Challenge to the competence of notified bodies
1. The Commission, in conjunction with the MDCG, shall investig ate
all cases where concerns have been brought to its attention reg arding the
continued fulfilment by a notified body, or of one or more of i ts
subsidiaries or subcontractors, of the requirements set out in
Annex VII or the obligations to which they are subject. It shal l
ensure that the relevant authority responsible for notified bod ies is
informed and is given an opportunity to investigate those conce rns.
2. The notifying Member State shall provide the Commission, on
request, with all information regarding the designation of the notified
body concerned. ▼B
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(b) the authority responsible for notified bodies has confirmed that no
certificates relevant to the suspension will be issued, amended or
re-issued during the course of the suspension or restriction, a nd
states whether the notified body has the ca...
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3. The Commission, in conjunction with the MDCG, may initiate, as
applicable, the assessment procedure described in Article 39(3) and (4),
where there is reasonable concern about the ongoing compliance of a
notified body or a subsidiary or subcontractor of the notified body with
the requirements set out in Annex VII and where the investigati on by
the authority responsible for notified bodies is not deemed to have fully
addressed the concerns or upon request of the authority respons ible for
notified bodies. The reporting and outcome of that assessment s hall
follow the principles of Article 39. Alternatively, depending o n the
severity of the issue, the Commission, in conjunction with the
MDCG, may request that the authority responsible for notified b odies
allow the participation of up to two experts from the list esta blished
pursuant to Article 40 in an on-site assessment as part of the planned
monitoring and assessment activities in accordance with Article 44 and
as outlined in the annual assessment plan described in Article 44(4).
4. Where the Commission ascertains that a notified body no long er
meets the requirements for its designation, it shall inform the notifying
Member State accordingly and request it to take the necessary c orrective
measures, including the suspension, restriction or withdrawal o f the
designation if necessary.
Where the Member State fails to take the necessary corrective m easures,
the Commission may, by means of implementing acts, suspend, res trict
or withdraw the designation. Those implementing acts shall be a dopted
in accordance with the examination procedure referred to in
Article 114(3). It shall notify the Member State concerned of i ts
decision and update NANDO and the electronic system referred to in
Article 57.
5. The Commission shall ensure that all confidential informatio n
obtained in the course of its investigations is treated accordi ngly.
Article 48
Peer review and exchange of experience between authorities
responsible for notified bodies
1. The Commission shall provide for the organisation of exchang e of
experience and coordination of administrative practice between the auth
orities responsible for notified bodies. Such exchange shall co ver
elements including:
(a) development of best practice documents relating to the acti vities of
the authorities responsible for notified bodies;
(b) development of guidance documents for notified bodies in re lation
to the implementation of this Regulation;
(c) training and qualification of the experts referred to in Ar ticle 40;
(d) monitoring of trends relating to changes to notified body d esig
nations and notifications and trends in certificate withdrawals and
transfers between notified bodies; ▼B
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3. The Commission, in conjunction with the MDCG, may initiate, as
applicable, the assessment procedure described in Article 39(3) and (4),
where there is reasonable concern about the ongoing compliance of a
notified body or a subsidiary or subcontrac...
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(e) monitoring of the application and applicability of scope co des
referred to in Article 42(13);
(f) development of a mechanism for peer reviews between authori ties
and the Commission;
(g) methods of communication to the public on the monitoring an d
surveillance activities of authorities and the Commission on
notified bodies.
2. The authorities responsible for notified bodies shall partic ipate in a
peer review every third year through the mechanism developed pu rsuant
to paragraph 1 of this Article. Such reviews shall normally be conducted
in parallel with the on-site joint assessments described in Art icle 39.
Alternatively, an authority may make the choice of having such reviews
take place as part of its monitoring activities referred to in Article 44.
3. The Commission shall participate in the organisation and pro vide
support to the implementation of the peer review mechanism.
4. The Commission shall compile an annual summary report of the
peer review activities, which shall be made publicly available.
5. The Commission may, by means of implementing acts, adopt
measures setting out the detailed arrangements and related docu ments
for the peer review mechanism and training and qualification as referred
to in paragraph 1 of this Article. Those implementing acts shal l be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
Article 49
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and c ooper
ation between notified bodies is put in place and operated in t he form of
a coordination group of notified bodies in the field of medical devices,
including in vitro diagnostic medical devices. This group shall meet on
a regular basis and at least annually.
The bodies notified under this Regulation shall participate in the work
of that group.
The Commission may establish the specific arrangements for the func
tioning of the coordination group of notified bodies. ▼B
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(e) monitoring of the application and applicability of scope co des
referred to in Article 42(13);
(f) development of a mechanism for peer reviews between authori ties
and the Commission;
(g) methods of communication to the public on the monitoring...
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Article 50
List of standard fees
Notified bodies shall establish lists of their standard fees fo r the
conformity assessment activities that they carry out and shall make
those lists publicly available.
CHAPTER V
CLASSIFICATION AND CONFORMITY ASSESSMENT
SECTION 1
Classification
Article 51
Classification of devices
1. Devices shall be divided into classes I, IIa, IIb and III, t aking into
account the intended purpose of the devices and their inherent risks.
Classification shall be carried out in accordance with Annex VI II.
2. Any dispute between the manufacturer and the notified body
concerned, arising from the application of Annex VIII, shall be
referred for a decision to the competent authority of the Membe r State
in which the manufacturer has its registered place of business. In cases
where the manufacturer has no registered place of business in t he Union
and has not yet designated an authorised representative, the ma tter shall
be referred to the competent authority of the Member State in w hich the
authorised representative referred to in the last indent of poi nt (b) of
the second paragraph of Section 2.2 of Annex IX has its registe red
place of business. Where the notified body concerned is establi shed
in a Member State other than that of the manufacturer, the comp etent
authority shall adopt its decision after consultation with the competent
authority of the Member State that designated the notified body .
The competent authority of the Member State in which the manufa cturer
has its registered place of business shall notify the MDCG and the
Commission of its decision. The decision shall be made availabl e
upon request.
3. At the request of a Member State the Commission shall after
consulting the MDCG, decide, by means of implementing acts, on the
following:
(a) application of Annex VIII to a given device, or category or group of
devices, with a view to determining the classification of such
devices;
(b) that a device, or category or group of devices, shall for r easons of
public health based on new scientific evidence, or based on any
information which becomes available in the course of the vigila nce
and market surveillance activities be reclassified, by way of d ero
gation from Annex VIII.
4. The Commission may also, on its own initiative and after
consulting the MDCG, decide, by means of implementing acts, on the
issues referred to in points (a) and (b) of paragraph 3. ▼B
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Article 50
List of standard fees
Notified bodies shall establish lists of their standard fees fo r the
conformity assessment activities that they carry out and shall make
those lists publicly available.
CHAPTER V
CLASSIFICATION AND CONFORMITY A...
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5. In order to ensure the uniform application of Annex VIII, an d
taking account of the relevant scientific opinions of the relev ant
scientific committees, the Commission may adopt implementing ac ts
to the extent necessary to resolve issues of divergent interpre tation
and of practical application.
6. The implementing acts referred to in paragraphs 3, 4 and 5 o f this
Article shall be adopted in accordance with the examination pro cedure
referred to in Article 114(3).
SECTION 2
Conformity assessment
Article 52
Conformity assessment procedures
1. Prior to placing a device on the market, manufacturers shall
undertake an assessment of the conformity of that device, in ac cordance
with the applicable conformity assessment procedures set out in
Annexes IX to XI.
2. Prior to putting into service a device that is not placed on the
market, manufacturers shall undertake an assessment of the conf ormity
of that device, in accordance with the applicable conformity as sessment
procedures set out in Annexes IX to XI.
3. Manufacturers of class III devices, other than custom-made o r
investigational devices, shall be subject to a conformity asses sment as
specified in Annex IX. Alternatively, the manufacturer may choo se to
apply a conformity assessment as specified in Annex X coupled w ith a
conformity assessment as specified in Annex XI.
4. Manufacturers of class IIb devices, other than custom-made o r
investigational devices, shall be subject to a conformity asses sment as
specified in Chapters I and III of Annex IX, and including an
assessment of the technical documentation as specified in Secti on 4
of that Annex of at least one representative device per generic device
group.
However, for class IIb implantable devices, except sutures, sta ples,
dental fillings, dental braces, tooth crowns, screws, wedges, p lates,
wires, pins, clips and connectors, the assessment of the techni cal docu
mentation as specified in Section 4 of Annex IX shall apply for every
device.
Alternatively, the manufacturer may choose to apply a conformit y
assessment based on type examination as specified in Annex X
coupled with a conformity assessment based on product conformit y
verification as specified in Annex XI. ▼B
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5. In order to ensure the uniform application of Annex VIII, an d
taking account of the relevant scientific opinions of the relev ant
scientific committees, the Commission may adopt implementing ac ts
to the extent necessary to resolve issues of diver...
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5. Where justified in view of well-established technologies, si milar to
those used in the exempted devices listed in the second subpara graph of
paragraph 4 of this Article, being used in other class IIb impl antable
devices, or where justified in order to protect the health and safety of
patients, users or other persons or other aspects of public hea lth, the
Commission is empowered to adopt delegated acts in accordance w ith
Article 115 to amend that list by adding other types of class I Ib
implantable devices to that list or removing devices therefrom.
6. Manufacturers of class IIa devices, other than custom-made o r
investigational devices, shall be subject to a conformity asses sment as
specified in Chapters I and III of Annex IX, and including an
assessment of the technical documentation as specified in Secti on 4
of that Annex of at least one representative device for each ca tegory
of devices.
Alternatively, the manufacturer may choose to draw up the techn ical
documentation set out in Annexes II and III coupled with a conf ormity
assessment as specified in Section 10 or Section 18 of Annex XI . The
assessment of the technical documentation shall apply for at le ast one
representative device for each category of devices.
7. Manufacturers of class I devices, other than custom-made or inves
tigational devices, shall declare the conformity of their produ cts by
issuing the EU declaration of conformity referred to in Article 19
after drawing up the technical documentation set out in Annexes II
and III. If those devices are placed on the market in sterile c ondition,
have a measuring function or are reusable surgical instruments, the
manufacturer shall apply the procedures set out in Chapters I a nd III
of Annex IX, or in Part A of Annex XI. However, the involvement of
the notified body in those procedures shall be limited:
(a) in the case of devices placed on the market in sterile cond ition, to
the aspects relating to establishing, securing and maintaining sterile
conditions;
(b) in the case of devices with a measuring function, to the as pects
relating to the conformity of the devices with the metrological
requirements;
(c) in the case of reusable surgical instruments, to the aspect s relating
to the reuse of the device, in particular cleaning, disinfectio n, ster
ilization, maintenance and functional testing and the related
instructions for use.
8. Manufacturers of custom-made devices shall follow the proced ure
set out in Annex XIII and draw up the statement set out in Sect ion 1 of
that Annex before placing such devices on the market.
In addition to the procedure applicable pursuant to the first
subparagraph, manufacturers of class III custom-made implantabl e
devices shall be subject to the conformity assessment as specif ied in
Chapter I of Annex IX. Alternatively, the manufacturer may choo se to
apply a conformity assessment as specified in Part A of Annex X I. ▼B
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5. Where justified in view of well-established technologies, si milar to
those used in the exempted devices listed in the second subpara graph of
paragraph 4 of this Article, being used in other class IIb impl antable
devices, or where justified in or...
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9. In addition to the procedures applicable pursuant to paragra ph 3,
4, 6, or 7 of this Article, in the case of devices referred to in the first
subparagraph of Article 1(8), the procedure specified in Sectio n 5.2 of
Annex IX or Section 6 of Annex X, as applicable, shall also app ly.
10. In addition to the procedures applicable pursuant to paragr aph 3,
4, 6, or 7 of this Article, in the case of devices that are cov ered by this
Regulation in accordance with point (f) or (g) of Article 1(6) and with
the first subparagraph of Article 1(10), the procedure specifie d in
Section 5.3 of Annex IX or Section 6 of Annex X, as applicable,
shall also apply.
11. In addition to the procedures applicable pursuant to paragr aph 3,
4, 6, or 7, in the case of devices that are composed of substan ces or of
combinations of substances that are intended to be introduced i nto the
human body via a body orifice or applied to the skin and that a re
absorbed by or locally dispersed in the human body, the procedu re
specified in Section 5.4 of Annex IX or Section 6 of Annex X, a s
applicable, shall also apply.
12. The Member State in which the notified body is established may
require that all or certain documents, including the technical documen
tation, audit, assessment and inspection reports, relating to t he
procedures referred to in paragraphs 1 to 7 and 9 to 11 be made
available in an official Union language(s) determined by that
Member State. In the absence of such requirement, those documen ts
shall be available in any official Union language acceptable to the
notified body.
13. Investigational devices shall be subject to the requirement s set
out in Articles 62 to 81.
14. The Commission may, by means of implementing acts, specify
detailed arrangements and procedural aspects with a view to ens uring
the harmonised application of the conformity assessment procedu res by
the notified bodies for any of the following aspects:
(a) the frequency and the sampling basis of the assessment of t he
technical documentation on a representative basis as set out in the
third paragraph of Section 2.3 and in Section 3.5 of Annex IX i n
the case of class IIa and class IIb devices, and in Section 10. 2 of
Annex XI in the case of class IIa devices;
(b) the minimum frequency of unannounced on-site audits and sam ple
tests to be conducted by notified bodies in accordance with
Section 3.4 of Annex IX, taking into account the risk-class and
the type of device;
(c) the physical, laboratory or other tests to be carried out b y notified
bodies in the context of sample tests, assessment of the techni cal
documentation and type examination in accordance with Sections
3.4 and 4.3 of Annex IX, Section 3 of Annex X and Section 15 of
Annex XI. ▼B
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9. In addition to the procedures applicable pursuant to paragra ph 3,
4, 6, or 7 of this Article, in the case of devices referred to in the first
subparagraph of Article 1(8), the procedure specified in Sectio n 5.2 of
Annex IX or Section 6 of Annex X...
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The implementing acts referred to in the first subparagraph sha ll be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
Article 53
Involvement of notified bodies in conformity assessment procedures
1. Where the conformity assessment procedure requires the
involvement of a notified body, the manufacturer may apply to a
notified body of its choice, provided that the chosen notified body is
designated for conformity assessment activities related to the types of
devices concerned. The manufacturer may not lodge an applicatio n in
parallel with another notified body for the same conformity ass essment
procedure.
2. The notified body concerned shall, by means of the electroni c
system referred to in Article 57, inform the other notified bod ies of
any manufacturer that withdraws its application prior to the no tified
body's decision regarding the conformity assessment.
3. When applying to a notified body under paragraph 1, manu
facturers shall declare whether they have withdrawn an applicat ion
with another notified body prior to the decision of that notifi ed body
and provide information about any previous application for the same
conformity assessment that has been refused by another notified body.
4. The notified body may require any information or data from t he
manufacturer, which is necessary in order to properly conduct t he
chosen conformity assessment procedure.
5. Notified bodies and the personnel of notified bodies shall c arry out
their conformity assessment activities with the highest degree of profes
sional integrity and the requisite technical and scientific com petence in
the specific field and shall be free from all pressures and ind ucements,
particularly financial, which might influence their judgement o r the
results of their conformity assessment activities, especially a s regards
persons or groups with an interest in the results of those acti vities.
Article 54
Clinical evaluation consultation procedure for certain class III and
class IIb devices
1. In addition to the procedures applicable pursuant to Article 52, a
notified body shall also follow the procedure regarding clinica l
evaluation consultation as specified in Section 5.1 of Annex IX or as
referred to in Section 6 of Annex X, as applicable, when perfor ming a
conformity assessment of the following devices:
(a) class III implantable devices, and
(b) class IIb active devices intended to administer and/or remo ve a
medicinal product, as referred to in Section 6.4 of Annex VIII
(Rule 12). ▼B
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The implementing acts referred to in the first subparagraph sha ll be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
Article 53
Involvement of notified bodies in conformity assessment procedures
1. Where the ...
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2. The procedure referred to in paragraph 1 shall not be requir ed for
the devices referred to therein:
(a) in the case of renewal of a certificate issued under this R egulation;
(b) where the device has been designed by modifying a device al ready
marketed by the same manufacturer for the same intended purpose ,
provided that the manufacturer has demonstrated to the satisfac tion
of the notified body that the modifications do not adversely af fect
the benefit-risk ratio of the device; or
(c) where the principles of the clinical evaluation of the devi ce type or
category have been addressed in a CS referred to in Article 9 a nd
the notified body confirms that the clinical evaluation of the manu
facturer for this device is in compliance with the relevant CS for
clinical evaluation of that kind of device.
3. The notified body shall notify the competent authorities, th e
authority responsible for notified bodies and the Commission th rough
the electronic system referred to in Article 57 of whether or n ot the
procedure referred to in paragraph 1 of this Article is to be a pplied. That
notification shall be accompanied by the clinical evaluation as sessment
report.
4. The Commission shall draw up an annual overview of devices
which have been subject to the procedure specified in Section 5 .1 of
Annex IX and referred to in Section 6 of Annex X. The annual
overview shall include the notifications in accordance with par agraph 3
of this Article and point (e) of Section 5.1 of Annex IX and a listing of
the cases where the notified body did not follow the advice fro m the
expert panel. The Commission shall submit this overview to the
European Parliament, to the Council and to the MDCG.
5. The Commission shall by 27 May 2025 draw up a report on the
operation of this Article and submit it to the European Parliam ent and to
the Council. The report shall take into account the annual over views and
any available relevant recommendations from the MDCG. On the ba sis
of that report the Commission shall, if appropriate, make propo sals for
amendments to this Regulation.
Article 55
Mechanism for scrutiny of conformity assessments of certain class
III and class IIb devices
1. A notified body shall notify the competent authorities of
certificates it has granted to devices for which the conformity
assessment has been performed pursuant to Article 54(1). Such n otifi
cation shall take place through the electronic system referred to in
Article 57 and shall include the summary of safety and clinical
performance pursuant to Article 32, the assessment report by th e
notified body, the instructions for use referred to in Section 23.4 of
Annex I, and, where applicable, the scientific opinion of the e xpert
panels referred to in Section 5.1 of Annex IX or Section 6 of
Annex X, as applicable. In the case of divergent views between the
notified body and the expert panels, a full justification shall also be
included. ▼B
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2. The procedure referred to in paragraph 1 shall not be requir ed for
the devices referred to therein:
(a) in the case of renewal of a certificate issued under this R egulation;
(b) where the device has been designed by modifying a device al ready ...
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2. A competent authority and, where applicable, the Commission
may, based on reasonable concerns apply further procedures in
accordance with Article 44, 45, 46, 47 or 94 and, where deemed
necessary, take appropriate measures in accordance with Article s 95
and 97.
3. The MDCG and, where applicable, the Commission, may, based
on reasonable concerns, request scientific advice from the expe rt panels
in relation to the safety and performance of any device.
Article 56
Certificates of conformity
1. The certificates issued by the notified bodies in accordance with
Annexes IX, X and XI shall be in an official Union language
determined by the Member State in which the notified body is es tab
lished or otherwise in an official Union language acceptable to the
notified body. The minimum content of the certificates shall be as set
out in Annex XII.
2. The certificates shall be valid for the period they indicate , which
shall not exceed five years. On application by the manufacturer , the
validity of the certificate may be extended for further periods , each
not exceeding five years, based on a re-assessment in accordanc e with
the applicable conformity assessment procedures. Any supplement to a
certificate shall remain valid as long as the certificate which it
supplements is valid.
3. Notified bodies may impose restrictions to the intended purp ose of
a device to certain groups of patients or require manufacturers to
undertake specific PMCF studies pursuant to Part B of Annex XIV .
4. Where a notified body finds that the requirements of this Re gu
lation are no longer met by the manufacturer, it shall, taking account of
the principle of proportionality, suspend or withdraw the certi ficate
issued or impose any restrictions on it unless compliance with such
requirements is ensured by appropriate corrective action taken by the
manufacturer within an appropriate deadline set by the notified body.
The notified body shall give the reasons for its decision.
5. The notified body shall enter in the electronic system refer red to in
Article 57 any information regarding certificates issued, inclu ding
amendments and supplements thereto, and regarding suspended, re in
stated, withdrawn or refused certificates and restrictions impo sed on
certificates. Such information shall be accessible to the publi c.
6. In the light of technical progress, the Commission is empowe red
to adopt delegated acts in accordance with Article 115 amending the
minimum content of the certificates set out in Annex XII.
Article 57
Electronic system on notified bodies and on certificates of
conformity
1. The Commission, after consulting the MDCG, shall set up and
manage an electronic system to collate and process the followin g
information: ▼B
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2. A competent authority and, where applicable, the Commission
may, based on reasonable concerns apply further procedures in
accordance with Article 44, 45, 46, 47 or 94 and, where deemed
necessary, take appropriate measures in accordance with Article...
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(a) the list of subsidiaries referred to in Article 37(3);
(b) the list of experts referred to in Article 40(2);
(c) the information relating to the notification referred to in
Article 42(10) and the amended notifications referred to in
Article 46(2);
(d) the list of notified bodies referred to in Article 43(2);
(e) the summary of the report referred to in Article 44(12);
(f) the notifications for conformity assessments and certificat es referred
to in Articles 54(3) and 55(1);
(g) withdrawal or refusals of applications for the certificates as referred
to in Article 53(2) and Section 4.3 of Annex VII;
(h) the information regarding certificates referred to in Artic le 56(5);
(i) the summary of safety and clinical performance referred to in
Article 32.
2. The information collated and processed by the electronic sys tem
shall be accessible to the competent authorities of the Member States, to
the Commission, where appropriate to the notified bodies and wh ere
provided elsewhere in this regulation or in Regulation (EU) 201 7/746 to
the public.
Article 58
Voluntary change of notified body
1. In cases where a manufacturer terminates its contract with a
notified body and enters into a contract with another notified body in
respect of the conformity assessment of the same device, the de tailed
arrangements for the change of notified body shall be clearly d efined in
an agreement between the manufacturer, the incoming notified bo dy
and, where practicable the outgoing notified body. That agreeme nt
shall cover at least the following aspects:
(a) the date on which the certificates issued by the outgoing n otified
body become invalid;
(b) the date until which the identification number of the outgo ing
notified body may be indicated in the information supplied by t he
manufacturer, including any promotional material;
(c) the transfer of documents, including confidentiality aspect s and
property rights;
(d) the date after which the conformity assessment tasks of the outgoing
notified body is assigned to the incoming notified body;
(e) the last serial number or lot number for which the outgoing notified
body is responsible. ▼B
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(a) the list of subsidiaries referred to in Article 37(3);
(b) the list of experts referred to in Article 40(2);
(c) the information relating to the notification referred to in
Article 42(10) and the amended notifications referred to in
Article 46...
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2. The outgoing notified body shall withdraw the certificates i t has
issued for the device concerned on the date on which they becom e
invalid.
Article 59
Derogation from the conformity assessment procedures
▼M1
1. By way of derogation from Article 52 of this Regulation or, for
the period from 24 April 2020 to 25 May 2021, by way of derogat ion
from Article 9(1) and (2) of Directive 90/385/EEC or from Artic le 11(1)
to (6) of Directive 93/42/EEC, any competent authority may auth orise,
on a duly justified request, the placing on the market or putti ng into
service within the territory of the Member State concerned, of a specific
device for which the applicable procedures referred to in those Articles
have not been carried out but use of which is in the interest o f public
health or patient safety or health.
▼B
2. The Member State shall inform the Commission and the other
Member States of any decision to authorise the placing on the m arket
or putting into service of a device in accordance with paragrap h 1 where
such authorisation is granted for use other than for a single p atient.
▼M1
The Member State may inform the Commission and the other Member
States of any authorisation granted in accordance with Article 9(9) of
Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC b efore
24 April 2020.
▼B
3. ►M1 Following a notification pursuant to paragraph 2 of this
Article, the Commission, in exceptional cases relating to publi c health
or patient safety or health, may, by means of implementing acts , extend
for a limited period of time the validity of an authorisation g ranted by a
Member State in accordance with paragraph 1 of this Article or, when
granted before 24 April 2020, in accordance with Article 9(9) o f
Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC t o the
territory of the Union and set the conditions under which the d evice
may be placed on the market or put into service. Those implemen ting
acts shall be adopted in accordance with the examination proced ure
referred to in Article 114(3). ◄
On duly justified imperative grounds of urgency relating to the health
and safety of humans, the Commission shall adopt immediately
applicable implementing acts in accordance with the procedure
referred to in Article 114(4).
Article 60
Certificate of free sale
1. For the purpose of export and upon request by a manufacturer or
an authorised representative, the Member State in which the man u
facturer or the authorised representative has its registered pl ace of
business shall issue a certificate of free sale declaring that the manu
facturer or the authorised representative, as applicable, has i ts registered
place of business on its territory and that the device in quest ion bearing ▼B
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2. The outgoing notified body shall withdraw the certificates i t has
issued for the device concerned on the date on which they becom e
invalid.
Article 59
Derogation from the conformity assessment procedures
▼M1
1. By way of derogation from Arti...
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the CE marking in accordance with this Regulation may be market ed in
the Union. The certificate of free sale shall set out the Basic UDI-DI of
the device as provided to the UDI database under Article 29. Wh ere a
notified body has issued a certificate pursuant to Article 56, the certifi
cate of free sale shall set out the unique number identifying t he certifi
cate issued by the notified body, as referred to in Section 3 o f Chapter II
of Annex XII.
2. The Commission may, by means of implementing acts, establish a
model for certificates of free sale, taking into account intern ational
practice as regards the use of certificates of free sale. Those implemen
ting acts shall be adopted in accordance with the advisory proc edure
referred to in Article 114(2).
CHAPTER VI
CLINICAL EVALUATION AND CLINICAL INVESTIGATIONS
Article 61
Clinical evaluation
1. Confirmation of conformity with relevant general safety and
performance requirements set out in Annex I under the normal
conditions of the intended use of the device, and the evaluatio n of
the undesirable side-effects and of the acceptability of the be nefit-risk-
ratio referred to in Sections 1 and 8 of Annex I, shall be base d on
clinical data providing sufficient clinical evidence, including where
applicable relevant data as referred to in Annex III.
The manufacturer shall specify and justify the level of clinica l evidence
necessary to demonstrate conformity with the relevant general s afety
and performance requirements. That level of clinical evidence s hall be
appropriate in view of the characteristics of the device and it s intended
purpose.
To that end, manufacturers shall plan, conduct and document a c linical
evaluation in accordance with this Article and Part A of Annex XIV.
2. For all class III devices and for the class IIb devices refe rred to in
point (b) of Article 54(1), the manufacturer may, prior to its clinical
evaluation and/or investigation, consult an expert panel as ref erred to in
Article 106, with the aim of reviewing the manufacturer's inten ded
clinical development strategy and proposals for clinical invest igation.
The manufacturer shall give due consideration to the views expr essed
by the expert panel. Such consideration shall be documented in the
clinical evaluation report referred to in paragraph 12 of this Article.
The manufacturer may not invoke any rights to the views express ed by
the expert panel with regard to any future conformity assessmen t
procedure.
3. A clinical evaluation shall follow a defined and methodologi cally
sound procedure based on the following:
(a) a critical evaluation of the relevant scientific literature currently
available relating to the safety, performance, design character istics
and intended purpose of the device, where the following conditi ons
are satisfied: ▼B
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the CE marking in accordance with this Regulation may be market ed in
the Union. The certificate of free sale shall set out the Basic UDI-DI of
the device as provided to the UDI database under Article 29. Wh ere a
notified body has issued a certifica...
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— it is demonstrated that the device subject to clinical evalua tion
for the intended purpose is equivalent to the device to which t he
data relate, in accordance with Section 3 of Annex XIV, and
— the data adequately demonstrate compliance with the relevant
general safety and performance requirements;
(b) a critical evaluation of the results of all available clini cal investi
gations, taking duly into consideration whether the investigati ons
were performed under Articles 62 to 80, any acts adopted
pursuant to Article 81, and Annex XV; and
(c) a consideration of currently available alternative treatmen t options
for that purpose, if any.
4. In the case of implantable devices and class III devices, cl inical
investigations shall be performed, except if:
— the device has been designed by modifications of a device alr eady
marketed by the same manufacturer,
— the modified device has been demonstrated by the manufacturer to
be equivalent to the marketed device, in accordance with Sectio n 3
of Annex XIV and this demonstration has been endorsed by the
notified body, and
— the clinical evaluation of the marketed device is sufficient to demon
strate conformity of the modified device with the relevant safe ty and
performance requirements.
In this case, the notified body shall check that the PMCF plan is
appropriate and includes post market studies to demonstrate the safety
and performance of the device.
In addition, clinical investigations need not be performed in t he cases
referred to in paragraph 6.
5. A manufacturer of a device demonstrated to be equivalent to an
already marketed device not manufactured by him, may also rely on
paragraph 4 in order not to perform a clinical investigation pr ovided that
the following conditions are fulfilled in addition to what is r equired in
that paragraph:
— the two manufacturers have a contract in place that explicitl y allows
the manufacturer of the second device full access to the techni cal
documentation on an ongoing basis, and
— the original clinical evaluation has been performed in compli ance
with the requirements of this Regulation,
and the manufacturer of the second device provides clear eviden ce
thereof to the notified body.
6. The requirement to perform clinical investigations pursuant to
paragraph 4 shall not apply to implantable devices and class II I devices:
(a) which have been lawfully placed on the market or put into s ervice
in accordance with Directive 90/385/EEC or Directive 93/42/EEC
and for which the clinical evaluation:
— is based on sufficient clinical data, and
— is in compliance with the relevant product-specific CS for th e
clinical evaluation of that kind of device, where such a CS is
available; or ▼B
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— it is demonstrated that the device subject to clinical evalua tion
for the intended purpose is equivalent to the device to which t he
data relate, in accordance with Section 3 of Annex XIV, and
— the data adequately demonstrate compliance with the ...
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(b) that are sutures, staples, dental fillings, dental braces, tooth crowns,
screws, wedges, plates, wires, pins, clips or connectors for wh ich
the clinical evaluation is based on sufficient clinical data an d is in
compliance with the relevant product-specific CS, where such a CS
is available.
7. Cases in which paragraph 4 is not applied by virtue of parag raph 6
shall be justified in the clinical evaluation report by the man ufacturer
and in the clinical evaluation assessment report by the notifie d body.
8. Where justified in view of well-established technologies, si milar to
those used in the exempted devices listed in point (b) of parag raph 6 of
this Article, being used in other devices, or where justified i n order to
protect the health and safety of patients, users or other perso ns or other
aspects of public health, the Commission is empowered to adopt
delegated acts in accordance with Article 115 to amend the list of
exempted devices referred to in the second subparagraph of Arti cle 52(4)
and in point (b) of paragraph 6 of this Article, by adding othe r types of
implantable or class III devices to that list or removing devic es
therefrom.
9. In the case of the products without an intended medical purp ose
listed in Annex XVI, the requirement to demonstrate a clinical benefit in
accordance with this Chapter and Annexes XIV and XV shall be
understood as a requirement to demonstrate the performance of t he
device. Clinical evaluations of those products shall be based o n
relevant data concerning safety, including data from post-marke t
surveillance, PMCF, and, where applicable, specific clinical in vesti
gation. Clinical investigations shall be performed for those pr oducts
unless reliance on existing clinical data from an analogous med ical
device is duly justified.
10. Without prejudice to paragraph 4, where the demonstration o f
conformity with general safety and performance requirements bas ed
on clinical data is not deemed appropriate, adequate justificat ion for
any such exception shall be given based on the results of the m anu
facturer's risk management and on consideration of the specific s of the
interaction between the device and the human body, the clinical
performance intended and the claims of the manufacturer. In suc h a
case, the manufacturer shall duly substantiate in the technical documen
tation referred to in Annex II why it considers a demonstration of
conformity with general safety and performance requirements tha t is
based on the results of non-clinical testing methods alone, inc luding
performance evaluation, bench testing and pre-clinical evaluati on, to
be adequate.
11. The clinical evaluation and its documentation shall be upda ted
throughout the life cycle of the device concerned with clinical data
obtained from the implementation of the manufacturer's PMCF pla n
in accordance with Part B of Annex XIV and the post-market
surveillance plan referred to in Article 84.
For class III devices and implantable devices, the PMCF evaluat ion
report and, if indicated, the summary of safety and clinical pe rformance
referred to in Article 32 shall be updated at least annually wi th such
data. ▼B
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(b) that are sutures, staples, dental fillings, dental braces, tooth crowns,
screws, wedges, plates, wires, pins, clips or connectors for wh ich
the clinical evaluation is based on sufficient clinical data an d is in
compliance with the relevant produ...
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12. The clinical evaluation, its results and the clinical evide nce
derived from it shall be documented in a clinical evaluation re port as
referred to in Section 4 of Annex XIV, which, except for custom -made
devices, shall be part of the technical documentation referred to in
Annex II relating to the device concerned.
13. Where necessary to ensure the uniform application of Annex XIV,
the Commission may, having due regard to technical and scientif ic
progress, adopt implementing acts to the extent necessary to re solve
issues of divergent interpretation and of practical application . Those
implementing acts shall be adopted in accordance with the exami nation
procedure referred to in Article 114(3).
Article 62
General requirements regarding clinical investigations conducted to
demonstrate conformity of devices
1. Clinical investigations shall be designed, authorised, condu cted,
recorded and reported in accordance with the provisions of this
Article and of Articles 63 to 80, the acts adopted pursuant to Article 81,
and Annex XV, where carried out as part of the clinical evaluat ion for
conformity assessment purposes, for one or more of the followin g
purposes:
(a) to establish and verify that, under normal conditions of us e, a device
is designed, manufactured and packaged in such a way that it is
suitable for one or more of the specific purposes listed in poi nt (1)
of Article 2, and achieves the performance intended as specifie d by
its manufacturer;
(b) to establish and verify the clinical benefits of a device a s specified
by its manufacturer;
(c) to establish and verify the clinical safety of the device a nd to
determine any undesirable side-effects, under normal conditions of
use of the device, and assess whether they constitute acceptabl e
risks when weighed against the benefits to be achieved by the
device.
2. Where the sponsor of a clinical investigation is not establi shed in
the Union, that sponsor shall ensure that a natural or legal pe rson is
established in the Union as its legal representative. Such lega l represen
tative shall be responsible for ensuring compliance with the sp onsor's
obligations pursuant to this Regulation, and shall be the addre ssee for
all communications with the sponsor provided for in this Regula tion.
Any communication with that legal representative shall be deeme d to be
a communication with the sponsor.
Member States may choose not to apply the first subparagraph to
clinical investigations to be conducted solely on their territo ry, or on
their territory and the territory of a third country, provided that they
ensure that the sponsor establishes at least a contact person o n their
territory in respect of that clinical investigation who shall b e the
addressee for all communications with the sponsor provided for in
this Regulation. ▼B
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12. The clinical evaluation, its results and the clinical evide nce
derived from it shall be documented in a clinical evaluation re port as
referred to in Section 4 of Annex XIV, which, except for custom -made
devices, shall be part of the technical d...
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3. Clinical investigations shall be designed and conducted in s uch a
way that the rights, safety, dignity and well-being of the subj ects par
ticipating in a clinical investigation are protected and prevai l over all
other interests and the clinical data generated are scientifica lly valid,
reliable and robust.
Clinical investigations shall be subject to scientific and ethi cal review.
The ethical review shall be performed by an ethics committee in
accordance with national law. Member States shall ensure that t he
procedures for review by ethics committees are compatible with the
procedures set out in this Regulation for the assessment of the appli
cation for authorisation of a clinical investigation. At least one lay
person shall participate in the ethical review.
4. A clinical investigation as referred to in paragraph 1 may b e
conducted only where all of the following conditions are met:
(a) the clinical investigation is the subject of an authorisati on by the
Member State(s) in which the clinical investigation is to be
conducted, in accordance with this Regulation, unless otherwise
stated;
(b) an ethics committee, set up in accordance with national law , has
not issued a negative opinion in relation to the clinical inves ti
gation, which is valid for that entire Member State under its
national law;
(c) the sponsor, or its legal representative or a contact perso n pursuant
to paragraph 2, is established in the Union;
(d) vulnerable populations and subjects are appropriately prote cted in
accordance with Articles 64 to 68;
(e) the anticipated benefits to the subjects or to public healt h justify the
foreseeable risks and inconveniences and compliance with this
condition is constantly monitored;
(f) the subject or, where the subject is not able to give infor med
consent, his or her legally designated representative has given
informed consent in accordance with Article 63;
(g) the subject or, where the subject is not able to give infor med
consent, his or her legally designated representative, has been
provided with the contact details of an entity where further
information can be received in case of need;
(h) the rights of the subject to physical and mental integrity, to privacy
and to the protection of the data concerning him or her in
accordance with Directive 95/46/EC are safeguarded;
(i) the clinical investigation has been designed to involve as little pain,
discomfort, fear and any other foreseeable risk as possible for the
subjects, and both the risk threshold and the degree of distres s are
specifically defined in the clinical investigation plan and con stantly
monitored;
(j) the medical care provided to the subjects is the responsibi lity of an
appropriately qualified medical doctor or, where appropriate, a
qualified dental practitioner or any other person entitled by
national law to provide the relevant patient care under clinica l
investigation conditions; ▼B
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3. Clinical investigations shall be designed and conducted in s uch a
way that the rights, safety, dignity and well-being of the subj ects par
ticipating in a clinical investigation are protected and prevai l over all
other interests and the clinical ...
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(k) no undue influence, including that of a financial nature, i s exerted
on the subject, or, where applicable, on his or her legally
designated representatives, to participate in the clinical
investigation;
(l) the investigational device(s) in question conform(s) to the
applicable general safety and performance requirements set out in
Annex I apart from the aspects covered by the clinical investig ation
and that, with regard to those aspects, every precaution has be en
taken to protect the health and safety of the subjects. This in cludes,
where appropriate, technical and biological safety testing and
pre-clinical evaluation, as well as provisions in the field of occu
pational safety and accident prevention, taking into considerat ion
the state of the art;
(m) the requirements of Annex XV are fulfilled.
5. Any subject, or, where the subject is not able to give infor med
consent, his or her legally designated representative, may, wit hout any
resulting detriment and without having to provide any justifica tion,
withdraw from the clinical investigation at any time by revokin g his
or her informed consent. Without prejudice to Directive 95/46/E C, the
withdrawal of the informed consent shall not affect the activit ies already
carried out and the use of data obtained based on informed cons ent
before its withdrawal.
6. The investigator shall be a person exercising a profession w hich is
recognised in the Member State concerned as qualifying for the role of
investigator on account of having the necessary scientific know ledge
and experience in patient care. Other personnel involved in con ducting
a clinical investigation shall be suitably qualified, by educat ion, training
or experience in the relevant medical field and in clinical res earch
methodology, to perform their tasks.
7. The facilities where the clinical investigation is to be con ducted
shall be suitable for the clinical investigation and shall be s imilar to the
facilities where the device is intended to be used.
Article 63
Informed consent
1. Informed consent shall be written, dated and signed by the p erson
performing the interview referred to in point (c) of paragraph 2, and by
the subject or, where the subject is not able to give informed consent,
his or her legally designated representative after having been duly
informed in accordance with paragraph 2. Where the subject is u nable
to write, consent may be given and recorded through appropriate alter
native means in the presence of at least one impartial witness. In that
case, the witness shall sign and date the informed consent docu ment.
The subject or, where the subject is not able to give informed consent,
his or her legally designated representative shall be provided with a
copy of the document or the record, as appropriate, by which
informed consent has been given. The informed consent shall be docu
mented. Adequate time shall be given for the subject or his or her
legally designated representative to consider his or her decisi on to
participate in the clinical investigation. ▼B
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(k) no undue influence, including that of a financial nature, i s exerted
on the subject, or, where applicable, on his or her legally
designated representatives, to participate in the clinical
investigation;
(l) the investigational device(s) in ques...
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2. Information given to the subject or, where the subject is no t able
to give informed consent, his or her legally designated represe ntative for
the purposes of obtaining his or her informed consent shall:
(a) enable the subject or his or her legally designated represe ntative to
understand:
(i) the nature, objectives, benefits, implications, risks and i ncon
veniences of the clinical investigations;
(ii) the subject's rights and guarantees regarding his or her
protection, in particular his or her right to refuse to partici pate
in and the right to withdraw from the clinical investigation at
any time without any resulting detriment and without having to
provide any justification;
(iii) the conditions under which the clinical investigations is to be
conducted, including the expected duration of the subject's
participation in the clinical investigation; and
(iv) the possible treatment alternatives, including the follow- up
measures if the participation of the subject in the clinical in ves
tigation is discontinued;
(b) be kept comprehensive, concise, clear, relevant, and unders tandable
to the subject or his or her legally designated representative;
(c) be provided in a prior interview with a member of the inves tigating
team who is appropriately qualified under national law;
(d) include information about the applicable damage compensatio n
system referred to in Article 69; and
(e) include the Union-wide unique single identification number of the
clinical investigation referred to in Article 70(1) and informa tion
about the availability of the clinical investigation results in
accordance with paragraph 6 of this Article.
3. The information referred to in paragraph 2 shall be prepared in
writing and be available to the subject or, where the subject i s not able
to give informed consent, his or her legally designated represe ntative.
4. In the interview referred to in point (c) of paragraph 2, sp ecial
attention shall be paid to the information needs of specific pa tient
populations and of individual subjects, as well as to the metho ds used
to give the information.
5. In the interview referred to in point (c) of paragraph 2, it shall be
verified that the subject has understood the information.
6. The subject shall be informed that a clinical investigation report
and a summary presented in terms understandable to the intended user
will be made available pursuant to Article 77(5) in the electro nic system
on clinical investigations referred to in Article 73 irrespecti ve of the
outcome of the clinical investigation, and shall be informed, t o the
extent possible, when they have become available. ▼B
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2. Information given to the subject or, where the subject is no t able
to give informed consent, his or her legally designated represe ntative for
the purposes of obtaining his or her informed consent shall:
(a) enable the subject or his or her legal...
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7. This Regulation is without prejudice to national law requiri ng that,
in addition to the informed consent given by the legally design ated
representative, a minor who is capable of forming an opinion an d
assessing the information given to him or her, shall also assen t in
order to participate in a clinical investigation.
Article 64
Clinical investigations on incapacitated subjects
1. In the case of incapacitated subjects who have not given, or have
not refused to give, informed consent before the onset of their inca
pacity, a clinical investigation may be conducted only where, i n addition
to the conditions set out in Article 62(4), all of the followin g conditions
are met:
(a) the informed consent of their legally designated representa tive has
been obtained;
(b) the incapacitated subjects have received the information re ferred to
in Article 63(2) in a way that is adequate in view of their cap acity
to understand it;
(c) the explicit wish of an incapacitated subject who is capabl e of
forming an opinion and assessing the information referred to in
Article 63(2) to refuse participation in, or to withdraw from, the
clinical investigation at any time, is respected by the investi gator;
(d) no incentives or financial inducements are given to subject s or their
legally designated representatives, except for compensation for
expenses and loss of earnings directly related to the participa tion
in the clinical investigation;
(e) the clinical investigation is essential with respect to inc apacitated
subjects and data of comparable validity cannot be obtained in
clinical investigations on persons able to give informed consen t,
or by other research methods;
(f) the clinical investigation relates directly to a medical co ndition from
which the subject suffers;
(g) there are scientific grounds for expecting that participati on in the
clinical investigation will produce a direct benefit to the inc a
pacitated subject outweighing the risks and burdens involved.
2. The subject shall as far as possible take part in the inform ed
consent procedure.
Article 65
Clinical investigations on minors
A clinical investigation on minors may be conducted only where, in
addition to the conditions set out in Article 62(4), all of the following
conditions are met:
(a) the informed consent of their legally designated representa tive has
been obtained; ▼B
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7. This Regulation is without prejudice to national law requiri ng that,
in addition to the informed consent given by the legally design ated
representative, a minor who is capable of forming an opinion an d
assessing the information given to him or h...
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02017R0745 — EN — 10.01.2025 — 005.001 — 77
(b) the minors have received the information referred to in Art icle 63(2)
in a way adapted to their age and mental maturity and from inve s
tigators or members of the investigating team who are trained o r
experienced in working with children;
(c) the explicit wish of a minor who is capable of forming an o pinion
and assessing the information referred to in Article 63(2) to r efuse
participation in, or to withdraw from, the clinical investigati on at
any time, is respected by the investigator;
(d) no incentives or financial inducements are given to the sub ject or
his or her legally designated representative except for compens ation
for expenses and loss of earnings directly related to the parti cipation
in the clinical investigation;
(e) the clinical investigation is intended to investigate treat ments for a
medical condition that only occurs in minors or the clinical in ves
tigation is essential with respect to minors to validate data o btained
in clinical investigations on persons able to give informed con sent
or by other research methods;
(f) the clinical investigation either relates directly to a med ical
condition from which the minor concerned suffers or is of such a
nature that it can only be carried out on minors;
(g) there are scientific grounds for expecting that participati on in the
clinical investigation will produce a direct benefit to the min or
subject outweighing the risks and burdens involved;
(h) the minor shall take part in the informed consent procedure in a way
adapted to his or her age and mental maturity;
(i) if during a clinical investigation the minor reaches the ag e of legal
competence to give informed consent as defined in national law, his
or her express informed consent shall be obtained before that
subject can continue to participate in the clinical investigati on.
Article 66
Clinical investigations on pregnant or breastfeeding women
A clinical investigation on pregnant or breastfeeding women may be
conducted only where, in addition to the conditions set out in
Article 62(4), all of the following conditions are met:
(a) the clinical investigation has the potential to produce a d irect benefit
for the pregnant or breastfeeding woman concerned, or her embry o,
foetus or child after birth, outweighing the risks and burdens
involved;
(b) where research is undertaken on breastfeeding women, partic ular
care is taken to avoid any adverse impact on the health of the child;
(c) no incentives or financial inducements are given to the sub ject
except for compensation for expenses and loss of earnings
directly related to the participation in the clinical investiga tion. ▼B
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(b) the minors have received the information referred to in Art icle 63(2)
in a way adapted to their age and mental maturity and from inve s
tigators or members of the investigating team who are trained o r
experienced in working with children;
(c) ...
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Article 67
Additional national measures
Member States may maintain additional measures regarding person s
performing mandatory military service, persons deprived of libe rty,
persons who, due to a judicial decision, cannot take part in cl inical
investigations, or persons in residential care institutions.
Article 68
Clinical investigations in emergency situations
1. By way of derogation from point (f) of Article 62(4), from p oints
(a) and (b) of Article 64(1) and from points (a) and (b) of Art icle 65,
informed consent to participate in a clinical investigation may be
obtained, and information on the clinical investigation may be given,
after the decision to include the subject in the clinical inves tigation,
provided that that decision is taken at the time of the first i ntervention
on the subject, in accordance with the clinical investigation p lan for that
clinical investigation and that all of the following conditions are
fulfilled:
(a) due to the urgency of the situation, caused by a sudden
life-threatening or other sudden serious medical condition, the
subject is unable to provide prior informed consent and to rece ive
prior information on the clinical investigation;
(b) there are scientific grounds to expect that participation o f the subject
in the clinical investigation will have the potential to produc e a
direct clinically relevant benefit for the subject resulting in a
measurable health-related improvement alleviating the suffering
and/or improving the health of the subject, or in the diagnosis of
its condition;
(c) it is not possible within the therapeutic window to supply all prior
information to and obtain prior informed consent from his or he r
legally designated representative;
(d) the investigator certifies that he or she is not aware of a ny
objections to participate in the clinical investigation previou sly
expressed by the subject;
(e) the clinical investigation relates directly to the subject' s medical
condition because of which it is not possible within the therap eutic
window to obtain prior informed consent from the subject or fro m
his or her legally designated representative and to supply prio r
information, and the clinical investigation is of such a nature that
it may be conducted exclusively in emergency situations;
(f) the clinical investigation poses a minimal risk to, and imp oses a
minimal burden on, the subject in comparison with the standard
treatment of the subject's condition.
2. Following an intervention pursuant to paragraph 1 of this Ar ticle,
informed consent in accordance with Article 63 shall be sought to
continue the participation of the subject in the clinical inves tigation,
and information on the clinical investigation shall be given, i n
accordance with the following requirements: ▼B
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Article 67
Additional national measures
Member States may maintain additional measures regarding person s
performing mandatory military service, persons deprived of libe rty,
persons who, due to a judicial decision, cannot take part in cl inical
i...
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(a) regarding incapacitated subjects and minors, the informed c onsent
shall be sought by the investigator from his or her legally
designated representative without undue delay and the informati on
referred to in Article 63(2) shall be given as soon as possible to the
subject and to his or her legally designated representative;
(b) regarding other subjects, the informed consent shall be sou ght by
the investigator without undue delay from the subject or his or her
legally designated representative, whichever can be done sooner ,
and the information referred to in Article 63(2) shall be given as
soon as possible to the subject or his or her legally designate d
representative, as applicable.
For the purposes of point (b) where informed consent has been o btained
from the legally designated representative, informed consent to continue
the participation in the clinical investigation shall be obtain ed from the
subject as soon as he or she is capable of giving informed cons ent.
3. If the subject or, where applicable, his or her legally desi gnated
representative does not give consent, he or she shall be inform ed of the
right to object to the use of data obtained from the clinical i nvestigation.
Article 69
Damage compensation
1. Member States shall ensure that systems for compensation for any
damage suffered by a subject resulting from participation in a clinical
investigation conducted on their territory are in place in the form of
insurance, a guarantee, or a similar arrangement that is equiva lent as
regards its purpose and which is appropriate to the nature and the extent
of the risk.
2. The sponsor and the investigator shall make use of the syste m
referred to in paragraph 1 in the form appropriate for the Memb er State
in which the clinical investigation is conducted.
Article 70
Application for clinical investigations
1. The sponsor of a clinical investigation shall submit an appl ication
to the Member State(s) in which the clinical investigation is t o be
conducted (referred to for the purposes of this Article as ‘Mem ber State
concerned’) accompanied by the documentation referred to in Cha pter II
of Annex XV.
The application shall be submitted by means of the electronic s ystem
referred to in Article 73, which shall generate a Union-wide un ique
single identification number for the clinical investigation, wh ich shall
be used for all relevant communication in relation to that clin ical inves
tigation. Within 10 days of it receiving the application, the M ember State
concerned shall notify the sponsor as to whether the clinical i nvesti
gation falls within the scope of this Regulation and as to whet her the
application dossier is complete in accordance with Chapter II o f
Annex XV.
2. Within one week of any change occurring in relation to the d ocu
mentation referred to in Chapter II of Annex XV, the sponsor sh all
update the relevant data in the electronic system referred to i n Article 73
and make that change to the documentation clearly identifiable. The
Member State concerned shall be notified of the update by means of
that electronic system. ▼B
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(a) regarding incapacitated subjects and minors, the informed c onsent
shall be sought by the investigator from his or her legally
designated representative without undue delay and the informati on
referred to in Article 63(2) shall be given as soon a...
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3. Where the Member State concerned finds that the clinical inv es
tigation applied for does not fall within the scope of this Reg ulation or
that the application dossier is not complete, it shall inform t he sponsor
thereof and shall set a time limit of maximum 10 days for the s ponsor to
comment or to complete the application by means of the electron ic
system referred to in Article 73. The Member State concerned ma y
extend this period by a maximum of 20 days where appropriate.
Where the sponsor has not provided comments nor completed the a ppli
cation within the time limit referred to in the first subparagr aph, the
application shall be deemed to have lapsed. Where the sponsor
considers the application does fall under the scope of this Reg ulation
and/or is complete but the Member State concerned does not, the appli
cation shall be considered to have been rejected. The Member St ate
concerned shall provide for an appeal procedure in respect of s uch
refusal.
The Member State concerned shall notify the sponsor within five days
of receipt of the comments or of the requested additional infor mation,
whether the clinical investigation is considered as falling wit hin the
scope of this Regulation and the application is complete.
4. The Member State concerned may also extend the period referr ed
to in paragraph 1 and 3 each by a further five days.
5. For the purposes of this Chapter, the date on which the spon sor is
notified in accordance with paragraph 1 or 3 shall be the valid ation date
of the application. Where the sponsor is not notified, the vali dation date
shall be the last day of the periods referred to in paragraphs 1, 3 and 4
respectively.
6. During the period when the application is being assessed, th e
Member State may request additional information from the sponso r.
The expiry of the period laid down in point (b) of paragraph 7 shall
be suspended from the date of the first request until such time as the
additional information has been received.
7. The sponsor may start the clinical investigation in the foll owing
circumstances:
(a) in the case of investigational class I devices or in the ca se of
non-invasive class IIa and class IIb devices, unless otherwise
stated by national law, immediately after the validation date o f
the application pursuant to paragraph 5, and provided that a
negative opinion which is valid for the entire Member State,
under national law, has not been issued by an ethics committee in
the Member State concerned in respect of the clinical investiga tion;
(b) in the case of investigational devices, other than those re ferred to in
point (a), as soon as the Member State concerned has notified t he
sponsor of its authorisation, and provided that a negative opin ion
which is valid for the entire Member State, under national law, has
not been issued by an ethics committee in the Member State
concerned in respect of the clinical investigation. The Member State
shall notify the sponsor of the authorisation within 45 days of the
validation date referred to in paragraph 5. The Member State ma y
extend this period by a further 20 days for the purpose of cons ulting
with experts. ▼B
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3. Where the Member State concerned finds that the clinical inv es
tigation applied for does not fall within the scope of this Reg ulation or
that the application dossier is not complete, it shall inform t he sponsor
thereof and shall set a time limit...
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8. The Commission is empowered to adopt delegated acts in
accordance with Article 115 amending, in the light of technical
progress and global regulatory developments, the requirements l aid
down in Chapter II of Annex XV.
9. In order to ensure the uniform application of the requiremen ts laid
down in Chapter II of Annex XV, the Commission may adopt imple
menting acts to the extent necessary to resolve issues of diver gent inter
pretation and of practical application. Those implementing acts shall be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
Article 71
Assessment by Member States
1. Member States shall ensure that the persons validating and
assessing the application, or deciding on it, do not have confl icts of
interest, are independent of the sponsor, the investigators inv olved and
of natural or legal persons financing the clinical investigatio n, as well as
free of any other undue influence.
2. Member States shall ensure that the assessment is done joint ly by
an appropriate number of persons who collectively have the nece ssary
qualifications and experience.
3. Member States shall assess whether the clinical investigatio n is
designed in such a way that potential remaining risks to subjec ts or
third persons, after risk minimization, are justified, when wei ghed
against the clinical benefits to be expected. They shall, while taking
into account applicable CS or harmonised standards, examine in
particular:
(a) the demonstration of compliance of the investigational devi ce(s)
with the applicable general safety and performance requirements ,
apart from the aspects covered by the clinical investigation, a nd
whether, with regard to those aspects, every precaution has bee n
taken to protect the health and safety of the subjects. This in cludes,
where appropriate, assurance of technical and biological safety
testing and pre-clinical evaluation;
(b) whether the risk-minimisation solutions employed by the spo nsor
are described in harmonised standards and, in those cases where the
sponsor does not use harmonised standards, whether the
risk-minimisation solutions provide a level of protection that is
equivalent to that provided by harmonised standards;
(c) whether the measures planned for the safe installation, put ting into
service and maintenance of the investigational device are adequ ate;
(d) the reliability and robustness of the data generated in the clinical
investigation, taking account of statistical approaches, design of the
investigation and methodological aspects, including sample size ,
comparator and endpoints;
(e) whether the requirements of Annex XV are met; ▼B
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8. The Commission is empowered to adopt delegated acts in
accordance with Article 115 amending, in the light of technical
progress and global regulatory developments, the requirements l aid
down in Chapter II of Annex XV.
9. In order to ensure the ...
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(f) in the case of devices for sterile use, evidence of the val idation of
the manufacturer's sterilisation procedures or information on t he
reconditioning and sterilisation procedures which have to be
conducted by the investigation site;
(g) the demonstration of the safety, quality and usefulness of any
components of animal or human origin or of substances, which
may be considered medicinal products in accordance with
Directive 2001/83/EC.
4. Member States shall refuse the authorisation of the clinical inves
tigation if:
(a) the application dossier submitted pursuant to Article 70(1) remains
incomplete;
(b) the device or the submitted documents, especially the inves tigation
plan and the investigator's brochure, do not correspond to the state
of scientific knowledge, and the clinical investigation, in par ticular,
is not suitable for providing evidence for the safety, performa nce
characteristics or benefit of the device on subjects or patient s,
(c) the requirements of Article 62 are not met, or
(d) any assessment under paragraph 3 is negative.
Member States shall provide for an appeal procedure in respect of a
refusal pursuant to the first subparagraph.
Article 72
Conduct of a clinical investigation
1. The sponsor and the investigator shall ensure that the clini cal
investigation is conducted in accordance with the approved clin ical
investigation plan.
2. In order to verify that the rights, safety and well-being of subjects
are protected, that the reported data are reliable and robust, and that the
conduct of the clinical investigation is in compliance with the
requirements of this Regulation, the sponsor shall ensure adequ ate
monitoring of the conduct of a clinical investigation. The exte nt and
nature of the monitoring shall be determined by the sponsor on the basis
of an assessment that takes into consideration all characterist ics of the
clinical investigation including the following:
(a) the objective and methodology of the clinical investigation ; and
(b) the degree of deviation of the intervention from normal cli nical
practice.
3. All clinical investigation information shall be recorded, pr ocessed,
handled, and stored by the sponsor or investigator, as applicab le, in such
a way that it can be accurately reported, interpreted and verif ied while
the confidentiality of records and the personal data of the sub jects
remain protected in accordance with the applicable law on perso nal
data protection.
4. Appropriate technical and organisational measures shall be i m
plemented to protect information and personal data processed ag ainst
unauthorised or unlawful access, disclosure, dissemination, alt eration, or
destruction or accidental loss, in particular where the process ing
involves transmission over a network. ▼B
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(f) in the case of devices for sterile use, evidence of the val idation of
the manufacturer's sterilisation procedures or information on t he
reconditioning and sterilisation procedures which have to be
conducted by the investigation site;
(g) the d...
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5. Member States shall inspect, at an appropriate level, invest igation
site(s) to check that clinical investigations are conducted in accordance
with the requirements of this Regulation and with the approved inves
tigation plan.
6. The sponsor shall establish a procedure for emergency situat ions
which enables the immediate identification and, where necessary , an
immediate recall of the devices used in the investigation.
Article 73
Electronic system on clinical investigations
1. The Commission shall, in collaboration with the Member State s,
set up, manage and maintain an electronic system:
(a) to create the single identification numbers for clinical in vestigations
referred to in Article 70(1);
(b) to be used as an entry point for the submission of all appl ications or
notifications for clinical investigations referred to in Articl es 70, 74,
75 and 78 and for all other submission of data, or processing o f data
in this context;
(c) for the exchange of information relating to clinical invest igations in
accordance with this Regulation between the Member States and
between them and the Commission including the exchange of
information referred to in Articles 70 and 76;
(d) for information to be provided by the sponsor in accordance with
Article 77, including the clinical investigation report and its
summary as required in paragraph 5 of that Article;
(e) for reporting on serious adverse events and device deficien cies and
related updates referred to in Article 80.
2. When setting up the electronic system referred in paragraph 1 of
this Article, the Commission shall ensure that it is interopera ble with the
EU database for clinical trials on medicinal products for human use set
up in accordance with Article 81 of Regulation (EU) No 536/2014 of
the European Parliament and of the Council ( 1 ) as concerns combined
clinical investigations of devices with a clinical trial under that Regu
lation.
3. The information referred to in point (c) of paragraph 1 shal l only
be accessible to the Member States and the Commission. The
information referred to in the other points of that paragraph s hall be
accessible to the public, unless, for all or parts of that info rmation,
confidentiality of the information is justified on any of the f ollowing
grounds:
(a) protection of personal data in accordance with Regulation ( EC)
No 45/2001;
(b) protection of commercially confidential information, especi ally in
the investigators brochure, in particular through taking into
account the status of the conformity assessment for the device,
unless there is an overriding public interest in disclosure; ▼B
( 1 ) Regulation (EU) No 536/2014 of the European Parliament and of the Council
of 16 April 2014 on clinical trials on medicinal products for h uman use, and
repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
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5. Member States shall inspect, at an appropriate level, invest igation
site(s) to check that clinical investigations are conducted in accordance
with the requirements of this Regulation and with the approved inves
tigation plan.
6. The sponsor shal...
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(c) effective supervision of the conduct of the clinical invest igation by
the Member State(s) concerned.
4. No personal data of subjects shall be publicly available.
5. The user interface of the electronic system referred to in
paragraph 1 shall be available in all official languages of the Union.
Article 74
Clinical investigations regarding devices bearing the CE marking
1. Where a clinical investigation is to be conducted to further assess,
within the scope of its intended purpose, a device which alread y bears
the CE marking in accordance with Article 20(1), (‘PMCF investi
gation’), and where the investigation would involve submitting
subjects to procedures additional to those performed under the normal
conditions of use of the device and those additional procedures are
invasive or burdensome, the sponsor shall notify the Member Sta tes
concerned at least 30 days prior to its commencement by means o f
the electronic system referred to in Article 73. The sponsor sh all
include the documentation referred to in Chapter II of Annex XV as
part of the notification. Points (b) to (k) and (m) ►C1 of Article 62(4),
Articles 75, 76 and 77, and Article 80(5) and (6), and the rele vant
provisions ◄ of Annex XV shall apply to PMCF investigations.
2. Where a clinical investigation is to be conducted to assess, outside
the scope of its intended purpose, a device which already bears the CE
marking in accordance with Article 20(1), Articles 62 to 81 sha ll apply.
Article 75
Substantial modifications to clinical investigations
1. If a sponsor intends to introduce modifications to a clinica l inves
tigation that are likely to have a substantial impact on the sa fety, health
or rights of the subjects or on the robustness or reliability o f the clinical
data generated by the investigation, it shall notify, within on e week, by
means of the electronic system referred to in Article 73 the
Member State(s) in which the clinical investigation is being or is to
be conducted of the reasons for and the nature of those modific ations.
The sponsor shall include an updated version of the relevant do cumen
tation referred to in Chapter II of Annex XV as part of the not ification.
Changes to the relevant documentation shall be clearly identifi able.
2. The Member State shall assess any substantial modification t o the
clinical investigation in accordance with the procedure laid do wn in
Article 71.
3. The sponsor may implement the modifications referred to in
paragraph 1 at the earliest 38 days after the notification refe rred to in
that paragraph, unless:
(a) the Member State in which the clinical investigation is bei ng or is to
be conducted has notified the sponsor of its refusal based on t he
grounds referred to in Article 71(4) or on considerations of pu blic
health, subject and user safety or health, of public policy, or ▼B
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(c) effective supervision of the conduct of the clinical invest igation by
the Member State(s) concerned.
4. No personal data of subjects shall be publicly available.
5. The user interface of the electronic system referred to in
paragraph 1 shall b...
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(b) an ethics committee in that Member State has issued a negat ive
opinion in relation to the substantial modification to the clin ical
investigation, which, in accordance with national law, is valid for
that entire Member State.
4. The Member State(s) concerned may extend the period referred to
in paragraph 3 by a further seven days, for the purpose of cons ulting
with experts.
Article 76
Corrective measures to be taken by Member States and information
exchange between Member States
1. Where a Member State in which a clinical investigation is be ing or
is to be conducted has grounds for considering that the require ments set
out in this Regulation are not met, it may take at least any of the
following measures on its territory:
(a) revoke the authorisation for the clinical investigation;
(b) suspend or terminate the clinical investigation;
(c) require the sponsor to modify any aspect of the clinical
investigation.
2. Before the Member State concerned takes any of the measures
referred to in paragraph 1 it shall, except where immediate act ion is
required, ask the sponsor or the investigator or both for their opinion.
That opinion shall be delivered within seven days.
3. Where a Member State has taken a measure referred to in
paragraph 1 of this Article or has refused a clinical investiga tion, or
has been notified by the sponsor of the early termination of a clinical
investigation on safety grounds, that Member State shall commun icate
the corresponding decision and the grounds therefor to all Memb er States
and the Commission by means of the electronic system referred t o in
Article 73.
4. Where an application is withdrawn by the sponsor prior to a
decision by a Member State, that information shall be made avai lable
through the electronic system referred to in Article 73 to all
Member States and the Commission.
Article 77
Information from the sponsor at the end of a clinical investigation
or in the event of a temporary halt or early termination
1. If the sponsor has temporarily halted a clinical investigati on or has
terminated a clinical investigation early, it shall inform with in 15 days
the Member State in which that clinical investigation has been
temporarily halted or terminated early, through the electronic system
referred to in Article 73, of the temporary halt or early termi nation,
providing a justification. In the event that the sponsor has te mporarily
halted or terminated early the clinical investigation on safety grounds, it
shall inform all Member States in which that clinical investiga tion is
being conducted thereof within 24 hours.
2. The end of a clinical investigation shall be deemed to coinc ide
with the last visit of the last subject unless another point in time for
such end is set out in the clinical investigation plan. ▼B
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(b) an ethics committee in that Member State has issued a negat ive
opinion in relation to the substantial modification to the clin ical
investigation, which, in accordance with national law, is valid for
that entire Member State.
4. The Member Sta...
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3. The sponsor shall notify each Member State in which a clinic al
investigation was being conducted of the end of that clinical i nvesti
gation in that Member State. That notification shall be made wi thin 15
days of the end of the clinical investigation in relation to th at
Member State.
4. If an investigation is conducted in more than one Member Sta te,
the sponsor shall notify all Member States in which that clinic al inves
tigation was conducted of the end of the clinical investigation in all
Member States. That notification shall be made within 15 days o f that
end of the clinical investigation.
5. Irrespective of the outcome of the clinical investigation, w ithin one
year of the end of the clinical investigation or within three m onths of
the early termination or temporary halt, the sponsor shall subm it to the
Member States in which a clinical investigation was conducted a clinical
investigation report as referred to in Section 2.8 of Chapter I and
Section 7 of Chapter III of Annex XV.
The clinical investigation report shall be accompanied by a sum mary
presented in terms that are easily understandable to the intend ed user.
Both the report and summary shall be submitted by the sponsor b y
means of the electronic system referred to in Article 73.
Where, for scientific reasons, it is not possible to submit the clinical
investigation report within one year of the end of the investig ation, it
shall be submitted as soon as it is available. In such case, th e clinical
investigation plan referred to in Section 3 of Chapter II of An nex XV
shall specify when the results of the clinical investigation ar e going to
be available, together with a justification.
6. The Commission shall issue guidelines regarding the content and
structure of the summary of the clinical investigation report.
In addition, the Commission may issue guidelines for the format ting and
sharing of raw data, for cases where the sponsor decides to sha re raw
data on a voluntary basis. Those guidelines may take as a basis and
adapt, where possible, existing guidelines for sharing of raw d ata in the
field of clinical investigations.
7. The summary and the clinical investigation report referred t o in
paragraph 5 of this Article shall become publicly accessible th rough the
electronic system referred to in Article 73, at the latest when the device
is registered in accordance with Article 29 and before it is pl aced on the
market. In cases of early termination or temporary halt, the su mmary
and the report shall become publicly accessible immediately aft er
submission.
If the device is not registered in accordance with Article 29 w ithin one
year of the summary and the report having been entered into the elec
tronic system pursuant to paragraph 5 of this Article, they sha ll become
publicly accessible at that point in time.
Article 78
Coordinated assessment procedure for clinical investigations
1. By means of the electronic system referred to in Article 73, the
sponsor of a clinical investigation to be conducted in more tha n one
Member State may submit, for the purpose of Article 70, a singl e
application that, upon receipt, is transmitted electronically t o all
Member States in which the clinical investigation is to be cond ucted. ▼B
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3. The sponsor shall notify each Member State in which a clinic al
investigation was being conducted of the end of that clinical i nvesti
gation in that Member State. That notification shall be made wi thin 15
days of the end of the clinical investiga...
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2. The sponsor shall propose in the single application referred to in
paragraph 1 that one of the Member States in which the clinical inves
tigation is to be conducted acts as coordinating Member State. The
Member States in which the clinical investigation is to be cond ucted
shall, within six days of submission of the application, agree on one of
them taking the role of the coordinating Member State. If they do not
agree on a coordinating Member State, the coordinating Member S tate
proposed by the sponsor shall assume that role.
3. Under the direction of the coordinating Member State referre d to
in paragraph 2, the Member States concerned shall coordinate th eir
assessment of the application, in particular of the documentati on
referred to in Chapter II of Annex XV.
However, the completeness of the documentation referred to in S ections
1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV shall b e
assessed separately by each Member State concerned in accordanc e
with Article 70(1) to (5).
4. With regard to documentation other than that referred to in the
second subparagraph of paragraph 3, the coordinating Member Sta te
shall:
(a) within six days of receipt of the single application, notif y the
sponsor that it is the coordinating Member State (‘notification
date’);
(b) for the purpose of the validation of the application, take into
account any considerations submitted within seven days of the
notification date by any Member State concerned;
(c) within 10 days of the notification date, assess whether the clinical
investigation falls within the scope of this Regulation and whe ther
the application is complete, and shall notify the sponsor
accordingly. Article 70(1) and (3) to (5) shall apply to the co or
dinating Member State in relation to that assessment;
(d) establish the results of its assessment in a draft assessme nt report to
be transmitted within 26 days of the validation date to the
Member States concerned. By day 38 after the validation date,
the other Member States concerned shall transmit their comments
and proposals on the draft assessment report and the underlying
application to the coordinating Member State which shall take
due account of those comments and proposals in its finalisation
of the final assessment report, to be transmitted within 45 day s of
the validation date to the sponsor and the other Member States
concerned.
The final assessment report shall be taken into account by all
Member States concerned when deciding on the sponsor's applicat ion
in accordance with Article 70(7).
5. As regards the assessment of the documentation referred to i n
the second subparagraph of paragraph 3, each Member State
concerned may request, on a single occasion, additional informa tion
from the sponsor. The sponsor shall submit the requested additi onal
information within the period set by the Member State concerned ,
which shall not exceed 12 days from the receipt of the request. The
expiry of the last deadline pursuant to point (d) of paragraph 4 shall be
suspended from the date of the request until such time as the a dditional
information has been received. ▼B
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2. The sponsor shall propose in the single application referred to in
paragraph 1 that one of the Member States in which the clinical inves
tigation is to be conducted acts as coordinating Member State. The
Member States in which the clinical invest...
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6. For class IIb and class III devices, the coordinating Member State
may also extend the periods referred to in paragraph 4 by a fur ther 50
days, for the purpose of consulting with experts.
7. The Commission may, by means of implementing acts, further
specify the procedures and timescales for coordinated assessmen ts to
be taken into account by Member States concerned when deciding on
the sponsor's application. Such implementing acts may also set out the
procedures and timescales for coordinated assessment in the cas e of
substantial modifications pursuant to paragraph 12 of this Arti cle, in
the case of reporting of adverse events pursuant to Article 80( 4) and
in the case of clinical investigations of combination products between
medical devices and medicinal products, where the latter are un der a
concurrent coordinated assessment of a clinical trial under Reg u
lation (EU) No 536/2014. Those implementing acts shall be adopt ed
in accordance with the examination procedure referred to in
Article 114(3).
8. Where the conclusion of the coordinating Member State
concerning the area of coordinated assessment is that the condu ct of
the clinical investigation is acceptable or acceptable subject to
compliance with specific conditions, that conclusion shall be d eemed
to be the conclusion of all Member States concerned.
Notwithstanding the first subparagraph, a Member State concerne d may
only disagree with the conclusion of the coordinating Member St ate
concerning the area of coordinated assessment on the following
grounds:
(a) when it considers that participation in the clinical invest igation
would lead to a subject receiving treatment inferior to that
received in normal clinical practice in that Member State conce rned;
(b) infringement of national law; or
▼C2
(c) considerations as regards subject safety and data reliabili ty and
robustness submitted under point (d) of paragraph 4.
▼B
Where one of the Member States concerned disagrees with the
conclusion on the basis of the second subparagraph of this para graph,
it shall communicate its disagreement, together with a detailed justifi
cation, through the electronic system referred to in Article 73 , to the
Commission, to all other Member States concerned and to the spo nsor.
9. Where the conclusion of the coordinating Member State
concerning the area of coordinated assessment is that the clini cal inves
tigation is not acceptable, that conclusion shall be deemed to be the
conclusion of all Member States concerned.
10. A Member State concerned shall refuse to authorise a clinic al
investigation if it disagrees with the conclusion of the coordi nating
Member State as regards any of the grounds referred to in the s econd
subparagraph of paragraph 8, or if it finds, on duly justified grounds,
that the aspects addressed in Sections 1.13, 3.1.3, 4.2, 4.3 an d 4.4 of
Chapter II of Annex XV are not complied with, or where an ethic s
committee has issued a negative opinion in relation to that cli nical
investigation, which is valid, in accordance with national law, for that
entire Member State. That Member State shall provide for an app eal
procedure in respect of such refusal. ▼B
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6. For class IIb and class III devices, the coordinating Member State
may also extend the periods referred to in paragraph 4 by a fur ther 50
days, for the purpose of consulting with experts.
7. The Commission may, by means of implementing acts, fur...
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11. Each Member State concerned shall notify the sponsor throug h
the electronic system referred to in Article 73 as to whether t he clinical
investigation is authorised, whether it is authorised subject t o conditions,
or whether authorisation has been refused. Notification shall b e done by
way of one single decision within five days of the transmission ,
pursuant to point (d) of paragraph 4, by the coordinating Membe r State
of the final assessment report. Where an authorisation of a cli nical
investigation is subject to conditions, those conditions may on ly be
such that, by their nature, they cannot be fulfilled at the tim e of that
authorisation.
12. Any substantial modifications as referred to in Article 75 shall be
notified to the Member States concerned by means of the electro nic
system referred to in Article 73. Any assessment as to whether there
are grounds for disagreement as referred to in the second subpa ra
graph of paragraph 8 of this Article shall be carried out under the
direction of the coordinating Member State, except for substant ial modi
fications concerning Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II
of Annex XV, which shall be assessed separately by each Member State
concerned.
13. The Commission shall provide administrative support to the coor
dinating Member State in the accomplishment of its tasks under this
Chapter.
▼M5
14. All Member States shall be required to apply the procedure set
out in this Article from the date corresponding to 5 years from the date
of publication of the notice referred to in Article 34(3), info rming that
the electronic system referred to in Article 33(2), point (e), is functional
and meets the functional specifications drawn up pursuant to
Article 34(1).
Before the date set out in the first subparagraph of this parag raph and at
the earliest 6 months from the date of publication of the notic e referred
to in that subparagraph, the procedure set out in this Article shall be
applied only by those Member States in which the clinical inves tigation
is to be conducted which have agreed to apply it.
▼B
Article 79
Review of coordinated assessment procedure
By 27 May 2026, the Commission shall submit to the European
Parliament and to the Council a report on experience gained fro m the
application of Article 78 and, if necessary, propose a review o f
Article 78(14) and point (h) of Article 123(3).
Article 80
Recording and reporting of adverse events that occur during
clinical investigations
1. The sponsor shall fully record all of the following:
(a) any adverse event of a type identified in the clinical inve stigation
plan as being critical to the evaluation of the results of that clinical
investigation;
(b) any serious adverse event;
(c) any device deficiency that might have led to a serious adve rse event
if appropriate action had not been taken, intervention had not
occurred, or circumstances had been less fortunate;
(d) any new findings in relation to any event referred to in po ints (a) to (c). ▼B
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11. Each Member State concerned shall notify the sponsor throug h
the electronic system referred to in Article 73 as to whether t he clinical
investigation is authorised, whether it is authorised subject t o conditions,
or whether authorisation has be...
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2. The sponsor shall report, without delay to all Member States in
which the clinical investigation is being conducted, all of the following
by means of the electronic system referred to in Article 73:
(a) any serious adverse event that has a causal relationship wi th the
investigational device, the comparator or the investigation pro cedure
or where such causal relationship is reasonably possible;
(b) any device deficiency that might have led to a serious adve rse event
if appropriate action had not been taken, intervention had not
occurred, or circumstances had been less fortunate;
(c) any new findings in relation to any event referred to in po ints (a)
and (b).
The period for reporting shall take account of the severity of the event.
Where necessary to ensure timely reporting, the sponsor may sub mit an
initial report that is incomplete followed up by a complete rep ort.
Upon request by any Member State in which the clinical investig ation is
being conducted, the sponsor shall provide all information refe rred to in
paragraph 1.
3. The sponsor shall also report to the Member States in which the
clinical investigation is being conducted any event referred to in
paragraph 2 of this Article that occurred in third countries in which a
clinical investigation is performed under the same clinical inv estigation
plan as the one applying to a clinical investigation covered by this
Regulation by means of the electronic system referred to in Art icle 73.
4. In the case of a clinical investigation for which the sponso r has
used the single application referred to in Article 78, the spon sor shall
report any event as referred to in paragraph 2 of this Article by means
of the electronic system referred to in Article 73. Upon receip t, this
report shall be transmitted electronically to all Member States in which
the clinical investigation is being conducted.
Under the direction of the coordinating Member State referred t o in
Article 78(2), the Member States shall coordinate their assessm ent of
serious adverse events and device deficiencies to determine whe ther to
modify, suspend or terminate the clinical investigation or whet her to
revoke the authorisation for that clinical investigation.
This paragraph shall not affect the rights of the other Member States to
perform their own evaluation and to adopt measures in accordanc e with
this Regulation in order to ensure the protection of public hea lth and
patient safety. The coordinating Member State and the Commissio n
shall be kept informed of the outcome of any such evaluation an d the
adoption of any such measures.
5. In the case of PMCF investigations referred to in Article 74 (1), the
provisions on vigilance laid down in Articles 87 to 90 and in t he acts
adopted pursuant to Article 91 shall apply instead of this Arti cle.
6. Notwithstanding paragraph 5, this Article shall apply where a
causal relationship between the serious adverse event and the
preceding investigational procedure has been established. ▼B
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2. The sponsor shall report, without delay to all Member States in
which the clinical investigation is being conducted, all of the following
by means of the electronic system referred to in Article 73:
(a) any serious adverse event that has a causa...
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Article 81
Implementing acts
The Commission may, by means of implementing acts, establish th e
detailed arrangements and procedural aspects necessary for the im
plementation of this Chapter as regards the following:
(a) harmonised electronic forms for the application for clinica l investi
gations and their assessment as referred to in Articles 70 and 78,
taking into account specific categories or groups of devices;
(b) the functioning of the electronic system referred to in Art icle 73;
(c) harmonised electronic forms for the notification of PMCF in vesti
gations as referred to in Article 74(1), and of substantial mod ifi
cations as referred to in Article 75;
(d) the exchange of information between Member States as referr ed to
in Article 76;
(e) harmonised electronic forms for the reporting of serious ad verse
events and device deficiencies as referred to in Article 80;
(f) the timelines for the reporting of serious adverse events a nd device
deficiencies, taking into account the severity of the event to be
reported as referred to in Article 80;
(g) uniform application of the requirements regarding the clini cal
evidence or data needed to demonstrate compliance with the
general safety and performance requirements set out in Annex I.
The implementing acts referred to in the first paragraph shall be adopted
in accordance with the examination procedure referred to in
Article 114(3).
Article 82
Requirements regarding other clinical investigations
1. Clinical investigations, not performed pursuant to any of th e
purposes listed in Article 62(1), shall comply with the provisi ons of
Article 62 (2) and (3), points (b), (c), (d), (f), (h), and (l) of Article 62(4)
and Article 62(6).
2. In order to protect the rights, safety, dignity and well-bei ng of
subjects and the scientific and ethical integrity of clinical i nvestigations
not performed for any of the purposes listed in Article 62(1), each
Member State shall define any additional requirements for such inves
tigations, as appropriate for each Member State concerned. ▼B
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Article 81
Implementing acts
The Commission may, by means of implementing acts, establish th e
detailed arrangements and procedural aspects necessary for the im
plementation of this Chapter as regards the following:
(a) harmonised electronic form...
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CHAPTER VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET
SURVEILLANCE
SECTION 1
Post-market surveillance
Article 83
Post-market surveillance system of the manufacturer
1. For each device, manufacturers shall plan, establish, docume nt,
implement, maintain and update a post-market surveillance syste m in
a manner that is proportionate to the risk class and appropriat e for the
type of device. That system shall be an integral part of the ma nu
facturer's quality management system referred to in Article 10( 9).
2. The post-market surveillance system shall be suited to activ ely and
systematically gathering, recording and analysing relevant data on the
quality, performance and safety of a device throughout its enti re
lifetime, and to drawing the necessary conclusions and to deter mining,
implementing and monitoring any preventive and corrective actio ns.
3. Data gathered by the manufacturer's post-market surveillance
system shall in particular be used:
(a) to update the benefit-risk determination and to improve the risk
management as referred to in Chapter I of Annex I;
(b) to update the design and manufacturing information, the ins tructions
for use and the labelling;
(c) to update the clinical evaluation;
(d) to update the summary of safety and clinical performance re ferred
to in Article 32;
(e) for the identification of needs for preventive, corrective or field
safety corrective action;
(f) for the identification of options to improve the usability,
performance and safety of the device;
(g) when relevant, to contribute to the post-market surveillanc e of other
devices; and
(h) to detect and report trends in accordance with Article 88.
The technical documentation shall be updated accordingly. ▼B
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CHAPTER VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET
SURVEILLANCE
SECTION 1
Post-market surveillance
Article 83
Post-market surveillance system of the manufacturer
1. For each device, manufacturers shall plan, establish, docume nt,
im...
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4. If, in the course of the post-market surveillance, a need fo r
preventive or corrective action or both is identified, the manu facturer
shall implement the appropriate measures and inform the compete nt
authorities concerned and, where applicable, the notified body. Where
a serious incident is identified or a field safety corrective a ction is
implemented, it shall be reported in accordance with Article 87 .
Article 84
Post-market surveillance plan
The post-market surveillance system referred to in Article 83 s hall be
based on a post-market surveillance plan, the requirements for which are
set out in ►C2 Section 1 of Annex III. ◄ For devices other than
custom-made devices, the post-market surveillance plan shall be part
of the technical documentation specified in Annex II.
Article 85
Post-market surveillance report
Manufacturers of class I devices shall prepare a post-market su rveillance
report summarising the results and conclusions of the analyses of the
post-market surveillance data gathered as a result of the post- market
surveillance plan referred to in Article 84 together with a rat ionale
and description of any preventive and corrective actions taken. The
report shall be updated when necessary and made available to th e
competent authority upon request.
Article 86
Periodic safety update report
1. Manufacturers of class IIa, class IIb and class III devices shall
prepare a periodic safety update report (‘PSUR’) for each devic e and
where relevant for each category or group of devices summarisin g the
results and conclusions of the analyses of the post-market surv eillance
data gathered as a result of the post-market surveillance plan referred to
in Article 84 together with a rationale and description of any preventive
and corrective actions taken. Throughout the lifetime of the de vice
concerned, that PSUR shall set out:
(a) the conclusions of the benefit-risk determination;
(b) the main findings of the PMCF; and
(c) the volume of sales of the device and an estimate evaluatio n of the
size and other characteristics of the population using the devi ce and,
where practicable, the usage frequency of the device.
Manufacturers of class IIb and class III devices shall update t he PSUR
at least annually. That PSUR shall, except in the case of custo m-made
devices, be part of the technical documentation as specified in
Annexes II and III. ▼B
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4. If, in the course of the post-market surveillance, a need fo r
preventive or corrective action or both is identified, the manu facturer
shall implement the appropriate measures and inform the compete nt
authorities concerned and, where applicable, ...
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Manufacturers of class IIa devices shall update the PSUR when
necessary and at least every two years. That PSUR shall, except in
the case of custom-made devices, be part of the technical docum entation
as specified in Annexes II and III.
For custom-made devices, the PSUR shall be part of the document ation
referred to in Section 2 of Annex XIII.
2. For class III devices or implantable devices, manufacturers shall
submit PSURs by means of the electronic system referred to in
Article 92 to the notified body involved in the conformity asse ssment
in accordance with Article 52. The notified body shall review t he report
and add its evaluation to that electronic system with details o f any
action taken. Such PSURs and the evaluation by the notified bod y
shall be made available to competent authorities through that e lectronic
system.
3. For devices other than those referred to in paragraph 2, man u
facturers shall make PSURs available to the notified body invol ved in
the conformity assessment and, upon request, to competent autho rities.
SECTION 2
Vigilance
Article 87
Reporting of serious incidents and field safety corrective actions
1. Manufacturers of devices made available on the Union market,
other than investigational devices, shall report, to the releva nt
competent authorities, in accordance with Articles 92(5) and (7 ), the
following:
(a) any serious incident involving devices made available on th e Union
market, except expected side-effects which are clearly document ed
in the product information and quantified in the technical docu men
tation and are subject to trend reporting pursuant to Article 8 8;
(b) any field safety corrective action in respect of devices ma de
available on the Union market, including any field safety corre ctive
action undertaken in a third country in relation to a device wh ich is
also legally made available on the Union market, if the reason for
the field safety corrective action is not limited to the device made
available in the third country.
The reports referred to in the first subparagraph shall be subm itted
through the electronic system referred to in Article 92.
2. As a general rule, the period for the reporting referred to in
paragraph 1 shall take account of the severity of the serious i ncident. ▼B
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Manufacturers of class IIa devices shall update the PSUR when
necessary and at least every two years. That PSUR shall, except in
the case of custom-made devices, be part of the technical docum entation
as specified in Annexes II and III.
For custom...
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3. Manufacturers shall report any serious incident as referred to in
point (a) of paragraph 1 immediately after they have establishe d the
causal relationship between that incident and their device or t hat such
causal relationship is reasonably possible and not later than 1 5 days
after they become aware of the incident.
4. Notwithstanding paragraph 3, in the event of a serious publi c
health threat the report referred to in paragraph 1 shall be pr ovided
immediately, and not later than 2 days after the manufacturer
becomes aware of that threat.
5. Notwithstanding paragraph 3, in the event of death or an una n
ticipated serious deterioration in a person's state of health t he report
shall be provided immediately after the manufacturer has establ ished
or as soon as it suspects a causal relationship between the dev ice and
the serious incident but not later than 10 days after the date on which
the manufacturer becomes aware of the serious incident.
6. Where necessary to ensure timely reporting, the manufacturer may
submit an initial report that is incomplete followed up by a co mplete
report.
7. If, after becoming aware of a potentially reportable inciden t, the
manufacturer is uncertain about whether the incident is reporta ble, it
shall nevertheless submit a report within the timeframe require d in
accordance with paragraphs 2 to 5.
8. Except in cases of urgency in which the manufacturer needs t o
undertake field safety corrective action immediately, the manuf acturer
shall, without undue delay, report the field safety corrective action
referred to in point (b) of paragraph 1 in advance of the field safety
corrective action being undertaken.
9. For similar serious incidents that occur with the same devic e or
device type and for which the root cause has been identified or a field
safety corrective action implemented or where the incidents are common
and well documented, the manufacturer may provide periodic summ ary
reports instead of individual serious incident reports, on cond ition that
the coordinating competent authority referred to in Article 89( 9), in
consultation with the competent authorities referred to in poin t (a) of
Article 92(8), has agreed with the manufacturer on the format, content
and frequency of the periodic summary reporting. Where a single
competent authority is referred to in points (a) and (b) of Art icle 92(8),
the manufacturer may provide periodic summary reports following
agreement with that competent authority.
10. The Member States shall take appropriate measures such as o rga
nising targeted information campaigns, to encourage and enable
healthcare professionals, users and patients to report to the c ompetent
authorities suspected serious incidents referred to in point (a ) of
paragraph 1.
The competent authorities shall record centrally at national le vel reports
they receive from healthcare professionals, users and patients.
11. Where a competent authority of a Member State obtains such
reports on suspected serious incidents referred to in point (a) of
paragraph 1 from healthcare professionals, users or patients, i t shall
take the necessary steps to ensure that the manufacturer of the device
concerned is informed of the suspected serious incident without delay. ▼B
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3. Manufacturers shall report any serious incident as referred to in
point (a) of paragraph 1 immediately after they have establishe d the
causal relationship between that incident and their device or t hat such
causal relationship is reasonably possi...
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Where the manufacturer of the device concerned considers that t he
incident is a serious incident, it shall provide a report in ac cordance
with paragraphs 1 to 5 of this Article on that serious incident to the
competent authority of the Member State in which that serious i ncident
occurred and shall take the appropriate follow-up action in acc ordance
with Article 89.
Where the manufacturer of the device concerned considers that t he
incident is not a serious incident or is an expected undesirabl e
side-effect, which will be covered by trend reporting in accord ance
with Article 88, it shall provide an explanatory statement. If the
competent authority does not agree with the conclusion of the
explanatory statement, it may require the manufacturer to provi de a
report in accordance with paragraphs 1 to 5 of this Article and
require it to ensure that appropriate follow-up action is taken in
accordance with Article 89.
Article 88
Trend reporting
1. Manufacturers shall report, by means of the electronic syste m
referred to in Article 92, any statistically significant increa se in the
frequency or severity of incidents that are not serious inciden ts or that
are expected undesirable side-effects that could have a signifi cant
impact on the benefit-risk analysis ►C2 referred to in Sections 1 and
8 of Annex I and which ◄ have led or may lead to risks to the h ealth or
safety of patients, users or other persons that are unacceptabl e when
weighed against the intended benefits. The significant increase shall be
established in comparison to the foreseeable frequency or sever ity of
such incidents in respect of the device, or category or group o f devices,
in question during a specific period as specified in the techni cal docu
mentation and product information.
The manufacturer shall specify how to manage the incidents refe rred to
in the first subparagraph and the methodology used for determin ing any
statistically significant increase in the frequency or severity of such
incidents, as well as the observation period, in the post-marke t
surveillance plan referred to in Article 84.
2. The competent authorities may conduct their own assessments on
the trend reports referred to in paragraph 1 and require the ma nufacturer
to adopt appropriate measures in accordance with this Regulatio n in
order to ensure the protection of public health and patient saf ety.
Each competent authority shall inform the Commission, the other
competent authorities and the notified body that issued the cer tificate,
of the results of such assessment and of the adoption of such m easures.
Article 89
Analysis of serious incidents and field safety corrective actions
1. Following the reporting of a serious incident pursuant to
Article 87(1), the manufacturer shall, without delay, perform t he
necessary investigations in relation to the serious incident an d the
devices concerned. This shall include a risk assessment of the
incident and field safety corrective action taking into account criteria
as referred to in paragraph 3 of this Article as appropriate. ▼B
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Where the manufacturer of the device concerned considers that t he
incident is a serious incident, it shall provide a report in ac cordance
with paragraphs 1 to 5 of this Article on that serious incident to the
competent authority of the Member State...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 97
The manufacturer shall co-operate with the competent authoritie s and
where relevant with the notified body concerned during the inve sti
gations referred to in the first subparagraph and shall not per form any
investigation which involves altering the device or a sample of the batch
concerned in a way which may affect any subsequent evaluation o f the
causes of the incident, prior to informing the competent author ities of
such action.
2. Member States shall take the necessary steps to ensure that any
information regarding a serious incident that has occurred with in their
territory, or a field safety corrective action that has been or is to be
undertaken within their territory, and that is brought to their knowledge
in accordance with Article 87 is evaluated centrally at nationa l level by
their competent authority, if possible together with the manufa cturer,
and, where relevant, the notified body concerned.
3. In the context of the evaluation referred to in paragraph 2, the
competent authority shall evaluate the risks arising from the r eported
serious incident and evaluate any related field safety correcti ve actions,
taking into account the protection of public health and criteri a such as
causality, detectability and probability of recurrence of the p roblem,
frequency of use of the device, probability of occurrence of di rect or
indirect harm, the severity of that harm, the clinical benefit of the
device, intended and potential users, and population affected. The
competent authority shall also evaluate the adequacy of the fie ld
safety corrective action envisaged or undertaken by the manufac turer
and the need for, and kind of, any other corrective action, in particular
taking into account the principle of inherent safety contained in
Annex I.
Upon request by the national competent authority, manufacturers shall
provide all documents necessary for the risk assessment.
4. The competent authority shall monitor the manufacturer's inv esti
gation of a serious incident. Where necessary, a competent auth ority
may intervene in a manufacturer's investigation or initiate an inde
pendent investigation.
5. The manufacturer shall provide a final report to the compete nt
authority setting out its findings from the investigation by me ans of
the electronic system referred to in Article 92. The report sha ll set
out conclusions and where relevant indicate corrective actions to be
taken.
6. In the case of devices referred to in the first subparagraph of
Article 1(8) and where the serious incident or field safety cor rective
action may be related to a substance which, if used separately, would be
considered to be a medicinal product, the evaluating competent
authority or the coordinating competent authority referred to i n
paragraph 9 of this Article shall, inform the national competen t
authority or the EMA, depending on which issued the scientific
opinion on that substance under Article 52(9), of that serious incident
or field safety corrective action. ▼B
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The manufacturer shall co-operate with the competent authoritie s and
where relevant with the notified body concerned during the inve sti
gations referred to in the first subparagraph and shall not per form any
investigation which involves altering th...
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02017R0745 — EN — 10.01.2025 — 005.001 — 98
In the case of devices covered by this Regulation in accordance with
point (g) of Article 1(6) and where the serious incident or fie ld safety
corrective action may be related to the derivatives of tissues or cells of
human origin utilised for the manufacture of the device, and in the case
of devices falling under this Regulation pursuant to Article 1( 10),
the competent authority or the coordinating competent authority
referred to in paragraph 9 of this Article shall inform the com petent
authority for human tissues and cells that was consulted by the notified
body in accordance with Article 52(10).
7. After carrying out the evaluation in accordance with paragra ph 3
of this Article, the evaluating competent authority shall, thro ugh the
electronic system referred to in Article 92, inform, without de lay, the
other competent authorities of the corrective action taken or e nvisaged
by the manufacturer or required of it to minimise the risk of r ecurrence
of the serious incident, including information on the underlyin g events
and the outcome of its assessment.
8. The manufacturer shall ensure that information about the fie ld
safety corrective action taken is brought without delay to the attention
of users of the device in question by means of a field safety n otice. The
field safety notice shall be edited in an official Union langua ge or
languages determined by the Member State in which the field saf ety
corrective action is taken. Except in cases of urgency, the con tent of the
draft field safety notice shall be submitted to the evaluating competent
authority or, in the cases referred to in paragraph 9, to the c oordinating
competent authority to allow it to make comments. Unless duly j ustified
by the situation of the individual Member State, the content of the field
safety notice shall be consistent in all Member States.
The field safety notice shall allow the correct identification of the device
or devices involved, in particular by including the relevant UD Is, and
the correct identification, in particular, by including the SRN , if already
issued, of the manufacturer that has undertaken the field safet y
corrective action. The field safety notice shall explain, in a clear
manner, without understating the level of risk, the reasons for the
field safety corrective action with reference to the device mal function
and associated risks for patients, users or other persons, and shall clearly
indicate all the actions to be taken by users.
The manufacturer shall enter the field safety notice in the ele ctronic
system referred to in Article 92 through which that notice shal l be
accessible to the public.
9. The competent authorities shall actively participate in a pr ocedure
in order to coordinate their assessments referred to in paragra ph 3 in the
following cases:
(a) where there is concern regarding a particular serious incid ent or
cluster of serious incidents relating to the same device or typ e of
device of the same manufacturer in more than one Member State; ▼B
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In the case of devices covered by this Regulation in accordance with
point (g) of Article 1(6) and where the serious incident or fie ld safety
corrective action may be related to the derivatives of tissues or cells of
human origin utilised for the ma...
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Summarize the content of the article and explain its significance in medical device regulation.
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02017R0745 — EN — 10.01.2025 — 005.001 — 99
(b) where the appropriateness of a field safety corrective acti on that is
proposed by a manufacturer in more than one Member State is in
question.
That coordinated procedure shall cover the following:
— designation of a coordinating competent authority on a case b y case
basis, when required;
— defining the coordinated assessment process, including the ta sks and
responsibilities of the coordinating competent authority and th e
involvement of other competent authorities.
Unless otherwise agreed between the competent authorities, the coor
dinating competent authority shall be the competent authority o f the
Member State in which the manufacturer has its registered place of
business.
The coordinating competent authority shall, through the electro nic
system referred to in Article 92, inform the manufacturer, the other
competent authorities and the Commission that it has assumed th e
role of coordinating authority.
10. The designation of a coordinating competent authority shall not
affect the rights of the other competent authorities to perform their own
assessment and to adopt measures in accordance with this Regula tion in
order to ensure the protection of public health and patient saf ety. The
coordinating competent authority and the Commission shall be ke pt
informed of the outcome of any such assessment and the adoption of
any such measures.
11. The Commission shall provide administrative support to the coor
dinating competent authority in the accomplishment of its tasks under
this Chapter.
Article 90
Analysis of vigilance data
The Commission shall, in collaboration with the Member States, put in
place systems and processes to actively monitor the data availa ble in the
electronic system referred to in Article 92, in order to identi fy trends,
patterns or signals in the data that may reveal new risks or sa fety
concerns.
Where a previously unknown risk is identified or the frequency of an
anticipated risk significantly and adversely changes the benefi t-risk
determination, the competent authority or, where appropriate, t he coor
dinating competent authority shall inform the manufacturer, or where
applicable the authorised representative, which shall then take the
necessary corrective actions.
Article 91
Implementing acts
The Commission may, by means of implementing acts, and after co nsul
tation of the MDCG, adopt the detailed arrangements and procedu ral
aspects necessary for the implementation of Articles 85 to 90 a nd 92 as
regards the following:
(a) the typology of serious incidents and field safety correcti ve actions
in relation to specific devices, or categories or groups of dev ices; ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 99
(b) where the appropriateness of a field safety corrective acti on that is
proposed by a manufacturer in more than one Member State is in
question.
That coordinated procedure shall cover the following:
— designation of a coordinating competent auth...
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02017R0745 — EN — 10.01.2025 — 005.001 — 100
(b) the reporting of serious incidents and field safety correct ive actions
and field safety notices, and the provision of periodic summary
reports, post-market surveillance reports, PSURs and trend repo rts
by manufacturers as referred to in Articles 85, 86, 87, 88 and 89
respectively;
(c) standard structured forms for electronic and non-electronic
reporting, including a minimum data set for reporting of
suspected serious incidents by healthcare professionals, users and
patients;
(d) timelines for the reporting of field safety corrective acti ons, and for
the provision by manufacturers of periodic summary reports and
trend reports, taking into account the severity of the incident to
be reported as referred to in Article 87;
(e) harmonised forms for the exchange of information between
competent authorities as referred to in Article 89;
(f) procedures for the designation of a coordinating competent
authority; the coordinated evaluation process, including tasks and
responsibilities of the coordinating competent authority and
involvement of other competent authorities in this process.
The implementing acts referred to in the first paragraph shall be adopted
in accordance with the examination procedure referred to in
Article 114(3).
Article 92
Electronic system on vigilance and on post-market surveillance
1. The Commission shall, in collaboration with the Member State s,
set up and manage an electronic system to collate and process t he
following information:
(a) the reports by manufacturers on serious incidents and field safety
corrective actions referred to in Article 87(1) and Article 89( 5);
(b) the periodic summary reports by manufacturers referred to i n
Article 87(9);
(c) the reports by manufacturers on trends referred to in Artic le 88;
(d) the PSURs referred to in Article 86;
(e) the field safety notices by manufacturers referred to in Ar ticle 89(8);
(f) the information to be exchanged between the competent autho rities
of the Member States and between them and the Commission in
accordance with Article 89(7) and (9).
That electronic system shall include relevant links to the UDI database. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 100
(b) the reporting of serious incidents and field safety correct ive actions
and field safety notices, and the provision of periodic summary
reports, post-market surveillance reports, PSURs and trend repo rts
by manufacturers as referred to in Articl...
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