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List and explain the regulatory requirements for medical devices.
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02017R0745 — EN — 10.01.2025 — 005.001 — 201
4.1. In addition to the obligations laid down in Section 2, the manufacturer
shall lodge with the notified body an application for assessmen t of the
technical documentation relating to the device which it plans t o place on
the market or put into service and which is covered by the qual ity
management system referred to in Section 2.
4.2. The application shall describe the design, manufacture and performance of
the device in question. It shall include the technical document ation as
referred to in Annexes II and III.
4.3. ►C1 The notified body shall assess the technical documentation usi ng
staff with proven knowledge ◄ and experience regarding the tech nology
concerned and its clinical application. The notified body may r equire the
application to be completed by having further tests carried out or
requesting further evidence to be provided to allow assessment of
conformity with the relevant requirements of the Regulation. Th e
notified body shall carry out adequate physical or laboratory t ests in
relation to the device or request the manufacturer to carry out such tests.
4.4. The notified body shall review the clinical evidence prese nted by the
manufacturer in the clinical evaluation report and the related clinical
evaluation that was conducted. The notified body shall employ d evice
reviewers with sufficient clinical expertise and, if necessary, use external
clinical experts with direct and current experience relating to the device in
question or the clinical condition in which it is utilised, for the purposes of
that review.
4.5. The notified body shall, in circumstances in which the cli nical evidence is
based partly or totally on data from devices which are claimed to be
equivalent to the device under assessment, assess the suitabili ty of using
such data, taking into account factors such as new indications and inno
vation. The notified body shall clearly document its conclusion s on the
claimed equivalence, and on the relevance and adequacy of the d ata for
demonstrating conformity. For any characteristic of the device claimed as
innovative by the manufacturer or for new indications, the noti fied body
shall assess to what extent specific claims are supported by sp ecific
pre-clinical and clinical data and risk analysis.
4.6. The notified body shall verify that the clinical evidence and the clinical
evaluation are adequate and shall verify the conclusions drawn by the
manufacturer on the conformity with the relevant general safety and
performance requirements. That verification shall include consi deration
of the adequacy of the benefit-risk determination, the risk man agement,
the instructions for use, the user training and the manufacture r's
post-market surveillance plan, and include a review of the need for, and
the adequacy of, the PMCF plan proposed, where applicable.
4.7. Based on its assessment of the clinical evidence, the noti fied body shall
consider the clinical evaluation and the benefit-risk determina tion, and
whether specific milestones need to be defined to allow the not ified
body to review updates to the clinical evidence that result fro m
post-market surveillance and PMCF data.
4.8. The notified body shall clearly document the outcome of it s assessment in
the clinical evaluation assessment report. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 201
4.1. In addition to the obligations laid down in Section 2, the manufacturer
shall lodge with the notified body an application for assessmen t of the
technical documentation relating to the device which it plans t o place on
the market or put into s...
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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 — 202
4.9. The notified body shall provide the manufacturer with a re port on the
technical documentation assessment, including a clinical evalua tion
assessment report. If the device conforms to the relevant provi sions of
this Regulation, the notified body shall issue an EU technical documen
tation assessment certificate. The certificate shall contain th e conclusions
of the technical documentation assessment, the conditions of th e
certificate's validity, the data needed for identification of t he approved
design, and, where appropriate, a description of the intended p urpose of
the device.
4.10. Changes to the approved device shall require approval fro m the notified
body which issued the EU technical documentation assessment cer tificate
where such changes could affect the safety and performance of t he device
or the conditions prescribed for use of the device. Where the m anufacturer
plans to introduce any of the above-mentioned changes it shall inform the
notified body which issued the EU technical documentation asses sment
certificate thereof. The notified body shall assess the planned changes and
decide whether the planned changes require a new conformity ass essment
in accordance with Article 52 or whether they could be addresse d by
means of a supplement to the EU technical documentation assessm ent
certificate. In the latter case, the notified body shall assess the changes,
notify the manufacturer of its decision and, where the changes are
approved, provide it with a supplement to the EU technical docu mentation
assessment certificate.
5. Specific additional procedures
5.1. Assessment procedure for certain class III and class IIb d evices
(a) For class III implantable devices, and for class IIb active devices
intended to administer and/or remove a medicinal product as
referred to in Section 6.4. of Annex VIII (Rule 12), the notifi ed
body shall, having verified the quality of clinical data suppor ting
the clinical evaluation report of the manufacturer referred to in
Article 61(12), prepare a clinical evaluation assessment report which
sets out its conclusions concerning the clinical evidence provi ded by
the manufacturer, in particular concerning the benefit-risk det er
mination, the consistency of that evidence with the intended
purpose, including the medical indication or indications and th e
PMCF plan referred to in Article 10(3) and Part B of Annex XIV.
The notified body shall transmit its clinical evaluation assess ment
report, along with the manufacturer's clinical evaluation docum en
tation, referred to in points (c) and (d) of Section 6.1 of Ann ex II,
to the Commission.
The Commission shall immediately transmit those documents to th e
relevant expert panel referred to in Article 106.
(b) The notified body may be requested to present its conclusio ns as
referred to in point (a) to the expert panel concerned.
(c) The expert panel shall decide, under the supervision of the
Commission, on the basis of all of the following criteria:
(i) the novelty of the device or of the related clinical proced ure
involved, and the possible major clinical or health impact ther eof;
(ii) a significantly adverse change in the benefit-risk profile of a
specific category or group of devices due to scientifically val id
health concerns in respect of components or source material or in
respect of the impact on health in the case of failure of the
device; ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 202
4.9. The notified body shall provide the manufacturer with a re port on the
technical documentation assessment, including a clinical evalua tion
assessment report. If the device conforms to the relevant provi sions of
this Regulation, the notified bo...
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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 — 203
(iii) a significantly increased rate of serious incidents repor ted in
accordance with Article 87 in respect of a specific category or
group of devices,
whether to provide a scientific opinion on the clinical evaluat ion
assessment report of the notified body based on the clinical
evidence provided by the manufacturer, in particular concerning the
benefit-risk determination, the consistency of that evidence wi th the
medical indication or indications and the PMCF plan. That scien tific
opinion shall be provided within a period of 60 days, starting on the
day of receipt of the documents from the Commission as referred to in
point (a). The reasons for the decision to provide a scientific opinion
on the basis of the criteria in points (i), (ii) and (iii) shal l be included
in the scientific opinion. Where the information submitted is n ot
sufficient for the expert panel to reach a conclusion, this sha ll be
stated in the scientific opinion.
(d) The expert panel may decide, under the supervision of the
Commission, on the basis of the criteria laid down in point (c) not
to provide a scientific opinion, in which case it shall inform the
notified body as soon as possible and in any event within 21 da ys
of receipt of the documents as referred to in point (a) from th e
Commission. The expert panel shall within that time limit provi de
the notified body and the Commission with the reasons for its
decision, whereupon the notified body may proceed with the cert ifi
cation procedure of that device.
(e) The expert panel shall within 21 days of receipt of the doc uments
from the Commission notify the Commission, through Eudamed
whether it intends to provide a scientific opinion, pursuant to point (c),
or whether it intends not to provide a scientific opinion, purs uant to
point (d).
(f) Where no opinion has been delivered within a period of 60 d ays, the
notified body may proceed with the certification procedure of t he
device in question.
(g) The notified body shall give due consideration to the views expressed
in the scientific opinion of the expert panel. Where the expert panel
finds that the level of clinical evidence is not sufficient or otherwise
gives rise to serious concerns about the benefit-risk determina tion, the
consistency of that evidence with the intended purpose, includi ng the
medical indication(s), and with the PMCF plan, the notified bod y
shall, if necessary, advise the manufacturer to restrict the in tended
purpose of the device to certain groups of patients or certain
medical indications and/or to impose a limit on the duration of
validity of the certificate, to undertake specific PMCF studies , to
adapt the instructions for use or the summary of safety and
performance, or to impose other restrictions in its conformity
assessment report, as appropriate. The notified body shall prov ide a
full justification where it has not followed the advice of the expert
panel in its conformity assessment report and the Commission sh all
without prejudice to Article 109 make both the scientific opini on of
the expert panel and the written justification provided by the notified
body publicly available via Eudamed.
(h) The Commission, after consultation with the Member States a nd
relevant scientific experts shall provide guidance for expert p anels
for consistent interpretation of the criteria in point (c) befo re
►M1 26 May 2021 ◄. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 203
(iii) a significantly increased rate of serious incidents repor ted in
accordance with Article 87 in respect of a specific category or
group of devices,
whether to provide a scientific opinion on the clinical evaluat ion
assessment report of the n...
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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 — 204
5.2. Procedure in the case of devices incorporating a medicinal substance
(a) Where a device incorporates, as an integral part, a substan ce which, if
used separately, may be considered to be a medicinal product wi thin the
meaning of point 2 of Article 1 of Directive 2001/83/EC, includ ing a
medicinal product derived from human blood or human plasma and that
has an action ancillary to that of the device, the quality, saf ety and
usefulness of the substance shall be verified by analogy with t he
methods specified in Annex I to Directive 2001/83/EC.
(b) Before issuing an EU technical documentation assessment cer tificate,
the notified body shall, having verified the usefulness of the substance
as part of the device and taking account of the intended purpos e of the
device, seek a scientific opinion from one of the competent aut horities
designated by the Member States in accordance with
Directive 2001/83/EC or from the EMA, either of which to be
referred to in this Section as ‘the medicinal products authorit y
consulted’ depending on which has been consulted under this poi nt,
on the quality and safety of the substance including the benefi t or risk
of the incorporation of the substance into the device. Where th e device
incorporates a human blood or plasma derivative or a substance that, if
used separately, may be considered to be a medicinal product fa lling
exclusively within the scope of the Annex to Regu
lation (EC) No 726/2004, the notified body shall seek the opini on
of the EMA.
(c) When issuing its opinion, the medicinal products authority consulted
shall take into account the manufacturing process and the data relating
to the usefulness of incorporation of the substance into the de vice as
determined by the notified body.
(d) The medicinal products authority consulted shall provide it s opinion to
the notified body within 210 days of receipt of all the necessa ry
documentation.
(e) The scientific opinion of the medicinal products authority consulted,
and any possible update of that opinion, shall be included in t he
documentation of the notified body concerning the device. The
notified body shall give due consideration to the views express ed in
the scientific opinion when making its decision. The notified b ody
shall not deliver the certificate if the scientific opinion is unfavourable
and shall convey its final decision to the medicinal products a uthority
consulted.
(f) Before any change is made with respect to an ancillary subs tance
incorporated in a device, in particular related to its manufact uring
process, the manufacturer shall inform the notified body of the
changes. That notified body shall seek the opinion of the medic inal
products authority consulted, in order to confirm that the qual ity and
safety of the ancillary substance remain unchanged. The medicin al
products authority consulted shall take into account the data r elating
to the usefulness of incorporation of the substance into the de vice as
determined by the notified body, in order to ensure that the ch anges
have no negative impact on the risk or benefit previously estab lished
concerning the incorporation of the substance into the device. The
medicinal products authority consulted shall provide its opinio n
within 60 days after receipt of all the necessary documentation
regarding the changes. The notified body shall not deliver the
supplement to the EU technical documentation assessment certifi cate
if the scientific opinion provided by the medicinal products au thority
consulted is unfavourable. The notified body shall convey its f inal
decision to the medicinal products authority consulted. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 204
5.2. Procedure in the case of devices incorporating a medicinal substance
(a) Where a device incorporates, as an integral part, a substan ce which, if
used separately, may be considered to be a medicinal product wi thin the
meaning of point 2 of Ar...
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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 — 205
(g) Where the medicinal products authority consulted obtains in formation
on the ancillary substance, which could have an impact on the r isk or
benefit previously established concerning the incorporation of the
substance into the device, it shall advise the notified body as to
whether this information has an impact on the risk or benefit
previously established concerning the incorporation of the subs tance
into the device. The notified body shall take that advice into account
in reconsidering its assessment of the conformity assessment
procedure.
5.3. Procedure in the case of devices manufactured utilising, o r incorporating,
tissues or cells of human or animal origin, or their derivative s, that are
non-viable or rendered non-viable
5.3.1. Tissues or cells of human origin or their derivatives
(a) For devices manufactured utilising derivatives of tissues o r cells of
human origin that are covered by this Regulation in accordance with
point (g) of Article 1(6) and for devices that incorporate, as an integral
part, tissues or cells of human origin, or their derivatives, c overed by
Directive 2004/23/EC, that have an action ancillary to that of the
device, the notified body shall, prior to issuing an EU technic al docu
mentation assessment certificate, seek a scientific opinion fro m one of
the competent authorities designated by the Member States in
accordance with Directive 2004/23/EC (‘human tissues and cells
competent authority’) on the aspects relating to the donation,
procurement and testing of tissues or cells of human origin or their
derivatives. The notified body shall submit a summary of the
preliminary conformity assessment which provides, among other
things, information about the non-viability of the human tissue s or
cells in question, their donation, procurement and testing and the
risk or benefit of the incorporation of the tissues or cells of human
origin or their derivatives into the device.
(b) Within 120 days of receipt of all the necessary documentati on, the
human tissues and cells competent authority shall provide to th e
notified body its opinion.
(c) The scientific opinion of the human tissues and cells compe tent
authority, and any possible update, shall be included in the do cumen
tation of the notified body concerning the device. The notified body
shall give due consideration to the views expressed in the scie ntific
opinion of the human tissues and cells competent authority when
making its decision. The notified body shall not deliver the ce rtificate
if that scientific opinion is unfavourable. It shall convey its final
decision to the human tissues and cells competent authority con cerned.
(d) Before any change is made with respect to non-viable tissue s or cells
of human origin or their derivatives incorporated in a device, in
particular relating to their donation, testing or procurement, the manu
facturer shall inform the notified body of the intended changes . The
notified body shall consult the authority that was involved in the
initial consultation, in order to confirm that the quality and safety of
the tissues or cells of human origin or their derivatives incor porated in
the device are maintained. The human tissues and cells competen t
authority concerned shall take into account the data relating t o the
usefulness of incorporation of the tissues or cells of human or igin or ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 205
(g) Where the medicinal products authority consulted obtains in formation
on the ancillary substance, which could have an impact on the r isk or
benefit previously established concerning the incorporation of the
substance into the device, it shall ad...
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02017R0745 — EN — 10.01.2025 — 005.001 — 206
their derivatives into the device as determined by the notified body, in
order to ensure that the changes have no negative impact on the
established benefit-risk ratio of the addition of the tissues o r cells of
human origin or their derivatives in the device. It shall provi de its
opinion within 60 days of receipt of all the necessary document ation
regarding the intended changes. The notified body shall not del iver a
supplement to the EU technical documentation assessment certifi cate
if the scientific opinion is unfavourable and shall convey its final
decision to the human tissues and cells competent authority con cerned.
5.3.2. Tissues or cells of animal origin or their derivatives
In the case of devices manufactured utilising animal tissue whi ch is
rendered non-viable or utilising non-viable products derived fr om animal
tissue, as referred to in Regulation (EU) No 722/2012, the noti fied body
shall apply the relevant requirements laid down in that Regulat ion.
5.4. Procedure in the case of devices that are composed of subs tances or of
combinations of substances that are absorbed by or locally disp ersed in the
human body
(a) The quality and safety of devices that are composed of subs tances or
of combinations of substances that are intended to be introduce d into
the human body via a body orifice or applied to the skin and th at are
absorbed by, or locally dispersed in, the human body, shall be verified
where applicable and only in respect of the requirements not co vered
by this Regulation, in accordance with the relevant requirement s laid
down in Annex I to Directive 2001/83/EC for the evaluation of
absorption, distribution, metabolism, excretion, local toleranc e,
toxicity, interaction with other devices, medicinal products or other
substances and potential for adverse reactions.
(b) In addition, for devices, or their products of metabolism, that are
systemically absorbed by the human body in order to achieve the ir
intended purpose, the notified body shall seek a scientific opi nion
from one of the competent authorities designated by the Member States
in accordance with Directive 2001/83/EC or from the EMA, either of
which to be referred to in this Section as ‘the medicinal produ cts
authority consulted’ depending on which has been consulted unde r
this point, on the compliance of the device with the relevant
requirements laid down in Annex I to Directive 2001/83/EC.
(c) The opinion of the medicinal products authority consulted s hall be
drawn up within 150 days of receipt of all the necessary
documentation.
(d) The scientific opinion of the medicinal products authority consulted,
and any possible update, shall be included in the documentation of the
notified body concerning the device. The notified body shall gi ve due
consideration to the views expressed in the scientific opinion when
making its decision and shall convey its final decision to the medicinal
products authority consulted.
6. Batch verification in the case of devices incorporating, as an integral part,
a medicinal substance which, if used separately, would be consi dered to be
a medicinal product derived from human blood or human plasma as
referred to in Article 1(8)
Upon completing the manufacture of each batch of devices that i ncor
porate, as an integral part, a medicinal substance which, if us ed separately,
would be considered to be a medicinal product derived from huma n blood
or human plasma as referred to in the first subparagraph of Art icle 1(8),
the manufacturer shall inform the notified body of the release of the batch
of devices and send it the official certificate concerning the release of the
batch of human blood or plasma derivative used in the device, i ssued by
a Member State laboratory or a laboratory designated for that p urpose by
a Member State in accordance with Article 114(2) of Directive
2001/83/EC. ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 206
their derivatives into the device as determined by the notified body, in
order to ensure that the changes have no negative impact on the
established benefit-risk ratio of the addition of the tissues o r cells of
human origin or their derivatives in...
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Provide a summary and key takeaways from the given text.
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02017R0745 — EN — 10.01.2025 — 005.001 — 207
CHAPTER III
ADMINISTRATIVE PROVISIONS
7. The manufacturer or, where the manufacturer does not have a registered
place of business in a Member State, its authorised representat ive shall, for
a period ending no sooner than 10 years, and in the case of imp lantable
devices no sooner than 15 years, after the last device has been placed on
the market, keep at the disposal of the competent authorities:
— the EU declaration of conformity,
— the documentation referred to in the fifth indent of Section 2.1 and in
particular the data and records arising from the procedures ref erred to
in point (c) of the second paragraph of Section 2.2,
— information on the changes referred to in Section 2.4,
— the documentation referred to in Section 4.2, and
— the decisions and reports from the notified body as referred to in this
Annex.
8. Each Member State shall require that the documentation refer red to in
Section 7 is kept at the disposal of competent authorities for the period
indicated in that Section in case a manufacturer, or its author ised repre
sentative, established within its territory goes bankrupt or ce ases its
business activity prior to the end of that period. ▼B
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CHAPTER III
ADMINISTRATIVE PROVISIONS
7. The manufacturer or, where the manufacturer does not have a registered
place of business in a Member State, its authorised representat ive shall, for
a period ending no sooner than 10 years, and in the case...
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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 — 208
ANNEX X
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
1. EU type-examination is the procedure whereby a notified body ascertains
and certifies that a device, including its technical documentat ion and
relevant life cycle processes and a corresponding representativ e sample of
the device production envisaged, fulfils the relevant provision s of this Regu
lation.
2. Application
The manufacturer shall lodge an application for assessment with a notified
body. The application shall include:
— the name of the manufacturer and address of the registered pl ace of
business of the manufacturer and, if the application is lodged by the
authorised representative, the name of the authorised represent ative and
the address of its registered place of business,
— the technical documentation referred to in Annexes II and III . The
applicant shall make a representative sample of the device prod uction
envisaged (‘type’) available to the notified body. The notified body may
request other samples as necessary, and
— a written declaration that no application has been lodged wit h any other
notified body for the same type, or information about any previ ous
application for the same type that was refused by another notif ied
body or was withdrawn by the manufacturer or its authorised rep resen
tative before that other notified body made its final assessmen t.
3. Assessment
The notified body shall:
(a) examine the application by using staff with proven knowledg e and
experience regarding the technology concerned and its clinical appli
cation. The notified body may require the application to be com pleted
by having further tests carried out or requesting further evide nce to be
provided to allow assessment of conformity with the relevant
requirements of this Regulation. The notified body shall carry out
adequate physical or laboratory tests in relation to the device or
request the manufacturer to carry out such tests;
(b) examine and assess the technical documentation for conformi ty with the
requirements of this Regulation that are applicable to the devi ce and
verify that the type has been manufactured in conformity with t hat
documentation; it shall also record the items designed in confo rmity
with the applicable standards referred to in Article 8 or with applicable
CS, and record the items not designed on the basis of the relev ant
standards referred to in Article 8 or of the relevant CS;
(c) review the clinical evidence presented by the manufacturer in the
clinical evaluation report in accordance with Section 4 of Anne x XIV.
The notified body shall employ device reviewers with sufficient clinical
expertise and, if necessary, use external clinical experts with direct and
current experience relating to the device in question or to the clinical
condition in which it is utilised, for the purposes of that rev iew; ▼B
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ANNEX X
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
1. EU type-examination is the procedure whereby a notified body ascertains
and certifies that a device, including its technical documentat ion and
relevant life cycle processes and a corresp...
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02017R0745 — EN — 10.01.2025 — 005.001 — 209
(d) in circumstances in which the clinical evidence is based pa rtly or totally
on data from devices which are claimed to be similar or equival ent to
the device under assessment, assess the suitability of using su ch data,
taking into account factors such as new indications and innovat ion. The
notified body shall clearly document its conclusions on the cla imed
equivalence, and on the relevance and adequacy of the data for demon
strating conformity;
(e) clearly document the outcome of its assessment in a pre-cli nical and
clinical evaluation assessment report as part of the EU type ex amination
report referred to in point (i);
(f) carry out or arrange for the appropriate assessments and th e physical or
laboratory tests necessary to verify whether the solutions adop ted by the
manufacturer meet the general safety and performance requiremen ts laid
down in this Regulation, in the event that the standards referr ed to in
Article 8 or the CS have not been applied. Where the device has to be
connected to another device or devices in order to operate as i ntended,
proof shall be provided that it conforms to the general safety and
performance requirements when connected to any such device or
devices having the characteristics specified by the manufacture r;
(g) carry out or arrange for the appropriate assessments and th e physical or
laboratory tests necessary to verify whether, in the event that the manu
facturer has chosen to apply the relevant harmonised standards, those
standards have actually been applied;
(h) agree with the applicant on the place where the necessary a ssessments
and tests are to be carried out; and
(i) draw up an EU type-examination report on the results of the
assessments and tests carried out under points (a) to (g).
4. Certificate
If the type conforms to this Regulation, the notified body shal l issue an
EU type-examination certificate. The certificate shall contain the name and
address of the manufacturer, the conclusions of the type examin ation
assessment, the conditions of the certificate's validity and th e data needed
for identification of the type approved. The certificate shall be drawn up in
accordance with Annex XII. The relevant parts of the documentat ion shall
be annexed to the certificate and a copy kept by the notified b ody.
5. Changes to the type
5.1. The applicant shall inform the notified body which issued the EU
type-examination certificate of any planned change to the appro ved type
or of its intended purpose and conditions of use.
5.2. Changes to the approved device including limitations of it s intended purpose
and conditions of use shall require approval from the notified body which
issued the EU type-examination certificate where such changes m ay affect
conformity with the general safety and performance requirements or with the
conditions prescribed for use of the product. The notified body shall
examine the planned changes, notify the manufacturer of its dec ision and
provide him with a supplement to the EU type-examination report . The
approval of any change to the approved type shall take the form of a
supplement to the EU type-examination certificate. ▼B
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(d) in circumstances in which the clinical evidence is based pa rtly or totally
on data from devices which are claimed to be similar or equival ent to
the device under assessment, assess the suitability of using su ch data,
taking into account factor...
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02017R0745 — EN — 10.01.2025 — 005.001 — 210
5.3. Changes to the intended purpose and conditions of use of t he approved
device, with the exception of limitations of the intended purpo se and
conditions of use, shall necessitate a new application for a co nformity
assessment.
6. Specific additional procedures
Section 5 of Annex IX shall apply with the proviso that any ref erence to an
EU technical documentation assessment certificate shall be unde rstood as a
reference to an EU type-examination certificate.
7. Administrative provisions
The manufacturer or, where the manufacturer does not have a reg istered
place of business in a Member State, its authorised representat ive shall, for a
period ending no sooner than 10 years, and in the case of impla ntable
devices no sooner than 15 years, after the last device has been placed on
the market, keep at the disposal of the competent authorities:
— the documentation referred to in the second indent of Section 2 ,
— information on the changes referred to in Section 5, and
— copies of EU type-examination certificates, scientific opinio ns and
reports and their additions/supplements.
Section 8 of Annex IX shall apply. ▼B
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5.3. Changes to the intended purpose and conditions of use of t he approved
device, with the exception of limitations of the intended purpo se and
conditions of use, shall necessitate a new application for a co nformity
assessment.
6. Specific addi...
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ANNEX XI
CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY
VERIFICATION
1. The objective of the conformity assessment based on product conformity
verification is to ensure that devices conform to the type for which an EU
type-examination certificate has been issued, and that they mee t the
provisions of this Regulation which apply to them.
2. Where an EU type-examination certificate has been issued in accordance
with Annex X, the manufacturer may either apply the procedure s et out in
Part A (production quality assurance) or the procedure set out in Part B
(product verification) of this Annex.
3. By way of derogation from Sections 1 and 2 above, the proced ures in this
Annex coupled with the drawing up of technical documentation as set out
in Annexes II and III may also be applied by manufacturers of c lass IIa
devices.
PART A
PRODUCTION QUALITY ASSURANCE
4. The manufacturer shall ensure that the quality management sy stem
approved for the manufacture of the devices concerned is implem ented,
shall carry out a final verification, as specified in Section 6 , and shall be
subject to the surveillance referred to in Section 7.
5. When the manufacturer fulfils the obligations laid down in S ection 4, it
shall draw up and keep an EU declaration of conformity in accor dance
with Article 19 and Annex IV for the device covered by the conf ormity
assessment procedure. By issuing an EU declaration of conformit y, the
manufacturer shall be deemed to ensure and to declare that the device
concerned conforms to the type described in the EU type-examina tion
certificate and meets the requirements of this Regulation which apply to
the device.
6. Quality management system
6.1. The manufacturer shall lodge an application for assessment of its quality
management system with a notified body. The application shall i nclude:
— all elements listed in Section 2.1 of Annex IX,
— the technical documentation referred to in Annexes II and III for the
types approved, and
— a copy of the EU type-examination certificates referred to in Section 4
of Annex X; if the EU type-examination certificates have been i ssued
by the same notified body with which the application is lodged, a
reference to the technical documentation and its updates and th e
certificates issued shall also be included in the application.
6.2. Implementation of the quality management system shall be s uch as to
ensure that there is compliance with the type described in the EU
type-examination certificate and with the provisions of this Re gulation
which apply to the devices at each stage. All the elements, req uirements
and provisions adopted by the manufacturer for its quality mana gement
system shall be documented in a systematic and orderly manner i n the
form of a quality manual and written policies and procedures, s uch as
quality programmes, quality plans and quality records. ▼B
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ANNEX XI
CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY
VERIFICATION
1. The objective of the conformity assessment based on product conformity
verification is to ensure that devices conform to the type for which an EU
type-examination certific...
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That documentation shall, in particular, include an adequate de scription of
all elements listed in points (a), (b), (d) and (e) of Section 2.2 of
Annex IX.
6.3. The first and second paragraph of Section 2.3 of Annex IX shall apply.
If the quality management system is such that it ensures that t he devices
conform to the type described in the EU type-examination certif icate and
that it conforms to the relevant provisions of this Regulation, the notified
body shall issue an EU quality assurance certificate. The notif ied body
shall notify the manufacturer of its decision to issue the cert ificate. That
decision shall contain the conclusions of the notified body's a udit and a
reasoned assessment.
6.4. Section 2.4 of Annex IX shall apply.
7. Surveillance
Section 3.1, the first, second and fourth indents of Section 3. 2, Sections 3.3,
3.4, 3.6 and 3.7 of Annex IX shall apply.
In the case of class III devices, surveillance shall also inclu de a check that
the quantities of produced or purchased raw material or crucial components
approved for the type and correspond to the quantities of finis hed devices.
8. Batch verification in the case of devices incorporating, as an integral part, a
medicinal substance which, if used separately, would be conside red to be a
medicinal product derived from human blood or human plasma refe rred to
in Article 1(8).
Upon completing the manufacture of each batch of devices that i ncor
porate, as an integral part, a medicinal substance which, if us ed separately,
would be considered to be a medicinal product derived from huma n blood
or human plasma referred to in the first subparagraph of Articl e 1(8), the
manufacturer shall inform the notified body of the release of t he batch of
devices and send it the official certificate concerning the rel ease of the
batch of human blood or plasma derivative used in the device, i ssued by
a Member State laboratory or a laboratory designated for that p urpose by
a Member State in accordance with Article 114(2) of Directive
2001/83/EC.
9. Administrative provisions
The manufacturer or, where the manufacturer does not have a reg istered
place of business in a Member State, its authorised representat ive shall, for
a period ending no sooner than 10 years, and in the case of imp lantable
devices no sooner than 15 years, after the last device has been placed on
the market, keep at the disposal of the competent authorities:
— the EU declaration of conformity,
— the documentation referred to in the fifth indent of Section 2.1 of
Annex IX,
— the documentation referred to in the eighth indent of Section 2.1 of
Annex IX, including the EU type-examination certificate referre d to in
Annex X,
— information on the changes referred to in Section 2.4 of Anne x IX, and ▼B
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That documentation shall, in particular, include an adequate de scription of
all elements listed in points (a), (b), (d) and (e) of Section 2.2 of
Annex IX.
6.3. The first and second paragraph of Section 2.3 of Annex IX shall apply.
If the quality...
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— the decisions and reports from the notified body as referred to in
Sections 2.3, 3.3 and 3.4 of Annex IX.
Section 8 of Annex IX shall apply.
10. Application to class IIa devices
10.1. By way of derogation from Section 5, by virtue of the EU declaration of
conformity the manufacturer shall be deemed to ensure and to de clare that
the class IIa devices in question are manufactured in conformit y with the
technical documentation referred to in Annexes II and III and m eet the
requirements of this Regulation which apply to them.
10.2. For class IIa devices the notified body shall assess, as part of the
assessment referred to in Section 6.3, whether the technical do cumentation
as referred to in Annexes II and III for the devices selected o n a represen
tative basis is compliant with this Regulation.
In choosing a representative sample or samples of devices, the notified
body shall take into account the novelty of the technology, sim ilarities in
design, technology, manufacturing and sterilisation methods, th e intended
use and the results of any previous relevant assessments (e.g. with regard
to physical, chemical, biological or clinical properties) that have been
carried out in accordance with this Regulation. The notified bo dy shall
document its rationale for the sample or samples of devices tak en.
10.3. Where the assessment under Section 10.2. confirms that th e class IIa
devices in question conform to the technical documentation refe rred to
in Annexes II and III and meet the requirements of this Regulat ion
which apply to them, the notified body shall issue a certificat e pursuant
to this Part of this Annex.
10.4. Samples additional to those taken for the initial conform ity assessment of
devices shall be assessed by the notified body as part of the s urveillance
assessment referred to in Section 7.
10.5. By way of derogation from Section 6, the manufacturer or its authorised
representative shall, for a period ending no sooner than 10 yea rs after the
last device has been placed on the market, keep at the disposal of the
competent authorities:
— the EU declaration of conformity,
— the technical documentation referred to in Annexes II and III , and
— the certificate referred to in Section 10.3.
Section 8 of Annex IX shall apply.
PART B
PRODUCT VERIFICATION
11. Product verification shall be understood to be the procedur e whereby after
examination of every manufactured device, the manufacturer, by issuing an
EU declaration of conformity in accordance with Article 19 and Annex IV,
shall be deemed to ensure and to declare that the devices which have been
subject to the procedure set out in Sections 14 and 15 conform to the type
described in the EU type-examination certificate and meet the r equirements
of this Regulation which apply to them. ▼B
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— the decisions and reports from the notified body as referred to in
Sections 2.3, 3.3 and 3.4 of Annex IX.
Section 8 of Annex IX shall apply.
10. Application to class IIa devices
10.1. By way of derogation from Section 5, by virtue of the EU dec...
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12. The manufacturer shall take all the measures necessary to e nsure that the
manufacturing process produces devices which conform to the typ e
described in the EU type-examination certificate and to the req uirements
of the Regulation which apply to them. Prior to the start of ma nufacture,
the manufacturer shall prepare documents defining the manufactu ring
process, in particular as regards sterilisation where necessary , together
with all routine, pre-established procedures to be implemented to ensure
homogeneous production and, where appropriate, conformity of th e devices
with the type described in the EU type-examination certificate and with the
requirements of this Regulation which apply to them.
In addition, for devices placed on the market in a sterile cond ition, and
only for those aspects of the manufacturing process designed to secure and
maintain sterility, the manufacturer shall apply the provisions of Sections 6
and 7.
13. The manufacturer shall undertake to institute and keep up t o date a post-
market surveillance plan, including a PMCF plan, and the proced ures
ensuring compliance with the obligations of the manufacturer re sulting
from the provisions on vigilance and post-market surveillance s ystem set
out in Chapter VII.
14. The notified body shall carry out the appropriate examinati ons and tests in
order to verify the conformity of the device with the requireme nts of the
Regulation by examining and testing every product as specified in
Section 15.
The examinations and tests referred to in the first paragraph o f this
Section shall not apply to aspects of the manufacturing process designed
to secure sterility.
15. Verification by examination and testing of every product
15.1. Every device shall be examined individually and the appro priate physical
or laboratory tests as defined in the relevant standard or stan dards referred
to in Article 8, or equivalent tests and assessments, shall be carried out in
order to verify, where appropriate, the conformity of the devic es with the
type described in the EU type-examination certificate and with the
requirements of this Regulation which apply to them.
15.2. The notified body shall affix, or have affixed, its ident ification number to
each approved device and shall draw up an EU product verificati on cer
tificate relating to the tests and assessments carried out.
16. Batch verification in the case of devices incorporating, as an integral part, a
medicinal substance which, if used separately, would be conside red to be a
medicinal product derived from human blood or human plasma refe rred to
in Article 1(8).
Upon completing the manufacture of each batch of devices that i ncor
porate, as an integral part, a medicinal substance which, if us ed separately,
would be considered to be a medicinal product derived from huma n blood
or human plasma referred to in the first subparagraph of Articl e 1(8), the
manufacturer shall inform the notified body of the release of t he batch of
devices and send it the official certificate concerning the rel ease of the
batch of human blood or plasma derivative used in the device, i ssued by
a Member State laboratory or a laboratory designated for that p urpose by
a Member State in accordance with Article 114(2) of Directive 2 001/83/EC. ▼B
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12. The manufacturer shall take all the measures necessary to e nsure that the
manufacturing process produces devices which conform to the typ e
described in the EU type-examination certificate and to the req uirements
of the Regulation which apply t...
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17. Administrative provisions
The manufacturer or its authorised representative shall, for a period ending
no sooner than 10 years, and in the case of implantable devices no sooner
than 15 years, after the last device has been placed on the mar ket, keep at
the disposal of the competent authorities:
— the EU declaration of conformity,
— the documentation referred to in Section 12,
— the certificate referred to in Section 15.2, and
— the EU type-examination certificate referred to in Annex X.
Section 8 of Annex IX shall apply.
18. Application to class IIa devices
18.1. By way of derogation from Section 11, by virtue of the EU declaration of
conformity the manufacturer shall be deemed to ensure and to de clare that
the class IIa devices in question are manufactured in conformit y with the
technical documentation referred to in Annexes II and III and m eet the
requirements of this Regulation which apply to them.
18.2. The verification conducted by the notified body in accord ance with
Section 14 is intended to confirm the conformity of the class I Ia devices
in question with the technical documentation referred to in Ann exes II and
III and with the requirements of this Regulation which apply to them.
18.3. If the verification referred to in Section 18.2 confirms that the class IIa
devices in question conform to the technical documentation refe rred to in
Annexes II and III and meet the requirements of this Regulation which
apply to them, the notified body shall issue a certificate purs uant to this
Part of this Annex.
18.4. By way of derogation from Section 17, the manufacturer or its authorised
representative shall, for a period ending no sooner than 10 yea rs after the
last device has been placed on the market, keep at the disposal of the
competent authorities:
— the EU declaration of conformity,
— the technical documentation referred to in Annexes II and III , and
— the certificate referred to in Section 18.3.
Section 8 of Annex IX shall apply. ▼B
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17. Administrative provisions
The manufacturer or its authorised representative shall, for a period ending
no sooner than 10 years, and in the case of implantable devices no sooner
than 15 years, after the last device has been placed on the mar ket...
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ANNEX XII
CERTIFICATES ISSUED BY A NOTIFIED BODY
CHAPTER I
GENERAL REQUIREMENTS
1. Certificates shall be drawn up in one of the official langua ges of the Union.
2. Each certificate shall refer to only one conformity assessme nt procedure.
3. Certificates shall only be issued to one manufacturer. The n ame and address
of the manufacturer included in the certificate shall be the sa me as that
registered in the electronic system referred to in Article 30.
4. The scope of the certificates shall unambiguously identify t he device or
devices covered:
(a) EU technical documentation assessment certificates, EU type -examination
certificates and EU product verification certificates shall inc lude a clear
identification, including the name, model and type, of the devi ce or
devices, the intended purpose, as included by the manufacturer in the
instructions for use and in relation to which the device has be en
assessed in the conformity assessment procedure, risk classific ation and
the Basic UDI-DI as referred to in Article 27(6);
(b) EU quality management system certificates and EU quality as surance
certificates shall include the identification of the devices or groups of
devices, the risk classification, and, for class IIb devices, t he intended
purpose.
5. The notified body shall be able to demonstrate on request, w hich (individual)
devices are covered by the certificate. The notified body shall set up a system
that enables the determination of the devices, including their classification,
covered by the certificate.
6. Certificates shall contain, if applicable, a note that, for the placing on the
market of the device or devices it covers, another certificate issued in
accordance with this Regulation is required.
7. EU quality management system certificates and EU quality ass urance
certificates for class I devices for which the involvement of a notified body
is required pursuant to Article 52(7) shall include a statement that the audit by
the notified body of the quality management system was limited to the aspects
required under that paragraph.
8. Where a certificate is supplemented, modified or re-issued, the new certificate
shall contain a reference to the preceding certificate and its date of issue with
identification of the changes.
CHAPTER II
MINIMUM CONTENT OF THE CERTIFICATES
1. name, address and identification number of the notified body ;
2. name and address of the manufacturer and, if applicable, of the authorised
representative; ▼B
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ANNEX XII
CERTIFICATES ISSUED BY A NOTIFIED BODY
CHAPTER I
GENERAL REQUIREMENTS
1. Certificates shall be drawn up in one of the official langua ges of the Union.
2. Each certificate shall refer to only one conformity assessme nt procedure.
3...
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3. unique number identifying the certificate;
4. if already issued, the SRN of the manufacturer referred to i n to Article 31(2);
5. date of issue;
6. date of expiry;
7. data needed for the unambiguous identification of the device or devices
where applicable as specified in Section 4 of Part I;
8. if applicable, reference to any previous certificate as spec ified in Section 8 of
Chapter I;
9. reference to this Regulation and the relevant Annex in accor dance with
which the conformity assessment has been carried out;
10. examinations and tests performed, e.g. reference to relevan t CS, harmonised
standards, test reports and audit report(s);
11. if applicable, reference to the relevant parts of the techn ical documentation or
other certificates required for the placing on the market of th e device or
devices covered;
12. if applicable, information about the surveillance by the no tified body;
13. conclusions of the notified body's conformity assessment wi th regard to the
relevant Annex;
14. conditions for or limitations to the validity of the certif icate;
15. legally binding signature of the notified body in accordanc e with the
applicable national law. ▼B
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3. unique number identifying the certificate;
4. if already issued, the SRN of the manufacturer referred to i n to Article 31(2);
5. date of issue;
6. date of expiry;
7. data needed for the unambiguous identification of the device or devices
w...
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ANNEX XIII
PROCEDURE FOR CUSTOM-MADE DEVICES
1. For custom-made devices, the manufacturer or its authorised representative
shall draw up a statement containing all of the following infor mation:
— the name and address of the manufacturer, and of all manufact uring sites,
— if applicable, the name and address of the authorised represe ntative,
— data allowing identification of the device in question,
— a statement that the device is intended for exclusive use by a particular
patient or user, identified by name, an acronym or a numerical code,
— the name of the person who made out the prescription and who is auth
orised by national law by virtue of their professional qualific ations to do
so, and, where applicable, the name of the health institution c oncerned,
— the specific characteristics of the product as indicated by t he prescription,
— a statement that the device in question conforms to the gener al safety and
performance requirements set out in Annex I and, where applicab le, indi
cating which general safety and performance requirements have n ot been
fully met, together with the grounds,
— where applicable, an indication that the device contains or i ncorporates a
medicinal substance, including a human blood or plasma derivati ve, or
tissues or cells of human origin, or of animal origin as referr ed to in
Regulation (EU) No 722/2012.
2. The manufacturer shall undertake to keep available for the c ompetent national
authorities documentation that indicates its manufacturing site or sites and
allows an understanding to be formed of the design, manufacture and
performance of the device, including the expected performance, so as to
allow assessment of conformity with the requirements of this Re gulation.
3. The manufacturer shall take all the measures necessary to en sure that the
manufacturing process produces devices which are manufactured i n
accordance with the documentation referred to in Section 2.
4. The statement referred to in the introductory part of Sectio n 1 shall be kept for
a period of at least 10 years after the device has been placed on the market. In
the case of implantable devices, the period shall be at least 1 5 years.
Section 8 of Annex IX shall apply.
5. The manufacturer shall review and document experience gained in the
post-production phase, including from PMCF as referred to in Pa rt B of
Annex XIV, and implement appropriate means to apply any necessa ry
corrective action, In that context, it shall report in accordan ce with
Article 87(1) to the competent authorities any serious incident s or field
safety corrective actions or both as soon as it learns of them. ▼B
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ANNEX XIII
PROCEDURE FOR CUSTOM-MADE DEVICES
1. For custom-made devices, the manufacturer or its authorised representative
shall draw up a statement containing all of the following infor mation:
— the name and address of the manufacturer, and of ...
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ANNEX XIV
CLINICAL EVALUATION AND POST-MARKET CLINICAL
FOLLOW-UP
PART A
CLINICAL EVALUATION
1. To plan, continuously conduct and document a clinical evalua tion, manu
facturers shall:
(a) establish and update a clinical evaluation plan, which shal l include at
least:
— an identification of the general safety and performance requi rements
that require support from relevant clinical data;
— a specification of the intended purpose of the device;
— a clear specification of intended target groups with clear in dications
and contra-indications;
— a detailed description of intended clinical benefits to patie nts with
relevant and specified clinical outcome parameters;
— a specification of methods to be used for examination of qual itative
and quantitative aspects of clinical safety with clear referenc e to the
determination of residual risks and side-effects;
— an indicative list and specification of parameters to be used to
determine, based on the state of the art in medicine, the accep tability
of the benefit-risk ratio for the various indications and for t he
intended purpose or purposes of the device;
— an indication how benefit-risk issues relating to specific co mponents
such as use of pharmaceutical, non-viable animal or human tissu es,
are to be addressed; and
— a clinical development plan indicating progression from explo ratory
investigations, such as first-in-man studies, feasibility and p ilot
studies, to confirmatory investigations, such as pivotal clinic al inves
tigations, and a PMCF as referred to in Part B of this Annex wi th an
indication of milestones and a description of potential accepta nce
criteria;
(b) identify available clinical data relevant to the device and its intended
purpose and any gaps in clinical evidence through a systematic scientific
literature review;
(c) appraise all relevant clinical data by evaluating their sui tability for
establishing the safety and performance of the device;
(d) generate, through properly designed clinical investigations in accordance
with the clinical development plan, any new or additional clini cal data
necessary to address outstanding issues; and
(e) analyse all relevant clinical data in order to reach conclu sions about the
safety and clinical performance of the device including its cli nical
benefits. ▼B
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ANNEX XIV
CLINICAL EVALUATION AND POST-MARKET CLINICAL
FOLLOW-UP
PART A
CLINICAL EVALUATION
1. To plan, continuously conduct and document a clinical evalua tion, manu
facturers shall:
(a) establish and update a clinical evaluation plan, whic...
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2. The clinical evaluation shall be thorough and objective, and take into
account both favourable and unfavourable data. Its depth and ex tent shall
be proportionate and appropriate to the nature, classification, intended
purpose and risks of the device in question, as well as to the manufacturer's
claims in respect of the device.
3. A clinical evaluation may be based on clinical data relating to a device for
which equivalence to the device in question can be demonstrated . The
following technical, biological and clinical characteristics sh all be taken
into consideration for the demonstration of equivalence:
— Technical: the device is of similar design; is used under sim ilar
conditions of use; has similar specifications and properties in cluding
physicochemical properties such as intensity of energy, tensile
strength, viscosity, surface characteristics, wavelength and so ftware
algorithms; uses similar deployment methods, where relevant; ha s
similar principles of operation and critical performance requir ements;
— Biological: the device uses the same materials or substances in contact
with the same human tissues or body fluids for a similar kind a nd
duration of contact and similar release characteristics of subs tances,
including degradation products and leachables;
— Clinical: the device is used for the same clinical condition or purpose,
including similar severity and stage of disease, at the same si te in the
body, in a similar population, including as regards age, anatom y and
physiology; has the same kind of user; has similar relevant cri tical
performance in view of the expected clinical effect for a speci fic
intended purpose.
The characteristics listed in the first paragraph shall be simi lar to the extent
that there would be no clinically significant difference in the safety and
clinical performance of the device. Considerations of equivalen ce shall be
based on proper scientific justification. It shall be clearly d emonstrated that
manufacturers have sufficient levels of access to the data rela ting to devices
with which they are claiming equivalence in order to justify th eir claims of
equivalence.
4. The results of the clinical evaluation and the clinical evid ence on which it is
based shall be documented in a clinical evaluation report which shall
support the assessment of the conformity of the device.
The clinical evidence together with non-clinical data generated from
non-clinical testing methods and other relevant documentation s hall allow
the manufacturer to demonstrate conformity with the general saf ety and
performance requirements and shall be part of the technical doc umentation
for the device in question.
Both favourable and unfavourable data considered in the clinica l evaluation
shall be included in the technical documentation.
PART B
POST-MARKET CLINICAL FOLLOW-UP
5. PMCF shall be understood to be a continuous process that upd ates the
clinical evaluation referred to in Article 61 and Part A of thi s Annex and
shall be addressed in the manufacturer's post-market surveillan ce plan.
When conducting PMCF, the manufacturer shall proactively collec t and
evaluate clinical data from the use in or on humans of a device which
bears the CE marking and is placed on the market or put into se rvice
within its intended purpose as referred to in the relevant conf ormity
assessment procedure, with the aim of confirming the safety and
performance throughout the expected lifetime of the device, of ensuring
the continued acceptability of identified risks and of detectin g emerging
risks on the basis of factual evidence. ▼B
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2. The clinical evaluation shall be thorough and objective, and take into
account both favourable and unfavourable data. Its depth and ex tent shall
be proportionate and appropriate to the nature, classification, intended
purpose and risks of the d...
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6. PMCF shall be performed pursuant to a documented method laid down in a
PMCF plan.
6.1. The PMCF plan shall specify the methods and procedures for proactively
collecting and evaluating clinical data with the aim of:
(a) confirming the safety and performance of the device through out its
expected lifetime,
(b) identifying previously unknown side-effects and monitoring the
identified side-effects and contraindications,
(c) identifying and analysing emergent risks on the basis of fa ctual
evidence,
(d) ensuring the continued acceptability of the benefit-risk ra tio referred to
in Sections 1 and 9 of Annex I, and
(e) identifying possible systematic misuse or off-label use of the device,
with a view to verifying that the intended purpose is correct.
6.2. The PMCF plan shall include at least:
(a) the general methods and procedures of the PMCF to be applie d, such as
gathering of clinical experience gained, feedback from users, s creening
of scientific literature and of other sources of clinical data;
(b) the specific methods and procedures of PMCF to be applied, such as
evaluation of suitable registers or PMCF studies;
(c) a rationale for the appropriateness of the methods and proc edures
referred to in points (a) and (b);
(d) a reference to the relevant parts of the clinical evaluatio n report referred
to in Section 4 and to the risk management referred to in Secti on 3 of
Annex I;
(e) the specific objectives to be addressed by the PMCF;
(f) an evaluation of the clinical data relating to equivalent o r similar
devices;
(g) reference to any relevant CS, harmonised standards when use d by the
manufacturer, and relevant guidance on PMCF; and
(h) a detailed and adequately justified time schedule for PMCF activities
(e.g. analysis of PMCF data and reporting) to be undertaken by the
manufacturer.
7. The manufacturer shall analyse the findings of the PMCF and document the
results in a PMCF evaluation report that shall be part of the c linical
evaluation report and the technical documentation.
8. The conclusions of the PMCF evaluation report shall be taken into account
for the clinical evaluation referred to in Article 61 and Part A of this
Annex and in the risk management referred to in Section 3 of An nex I.
If, through the PMCF, the need for preventive and/or corrective measures
has been identified, the manufacturer shall implement them. ▼B
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6. PMCF shall be performed pursuant to a documented method laid down in a
PMCF plan.
6.1. The PMCF plan shall specify the methods and procedures for proactively
collecting and evaluating clinical data with the aim of:
(a) confirming the safety a...
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ANNEX XV
CLINICAL INVESTIGATIONS
CHAPTER I
GENERAL REQUIREMENTS
1. Ethical principles
Each step in the clinical investigation, from the initial consi deration of the
need for and justification of the study to the publication of t he results,
shall be carried out in accordance with recognised ethical prin ciples.
2. Methods
2.1. Clinical investigations shall be performed on the basis of an appropriate
plan of investigation reflecting the latest scientific and tech nical
knowledge and defined in such a way as to confirm or refute the manu
facturer's claims regarding the safety, performance and aspects relating to
benefit-risk of devices as referred to in Article 62(1); the cl inical investi
gations shall include an adequate number of observations to gua rantee the
scientific validity of the conclusions. The rationale for the d esign and
chosen statistical methodology shall be presented as further de scribed in
Section 3.6 of Chapter II of this Annex.
2.2. The procedures used to perform the clinical investigation shall be appro
priate to the device under investigation.
2.3. The research methodologies used to perform the clinical in vestigation shall
be appropriate to the device under investigation.
2.4. Clinical investigations shall be performed in accordance w ith the clinical
investigation plan by a sufficient number of intended users and in a
clinical environment that is representative of the intended nor mal
conditions of use of the device in the target patient populatio n. Clinical
investigations shall be in line with the clinical evaluation pl an as referred
to in Part A of Annex XIV.
2.5. All the appropriate technical and functional features of t he device, in
particular those involving safety and performance, and their ex pected
clinical outcomes shall be appropriately addressed in the inves tigational
design. A list of the technical and functional features of the device and the
related expected clinical outcomes shall be provided.
2.6. The endpoints of the clinical investigation shall address the intended
purpose, clinical benefits, performance and safety of the devic e. The
endpoints shall be determined and assessed using scientifically valid
methodologies. The primary endpoint shall be appropriate to the device
and clinically relevant.
2.7. Investigators shall have access to the technical and clini cal data regarding
the device. Personnel involved in the conduct of an investigati on shall be
adequately instructed and trained in the proper use of the inve stigational
device, and as regards the clinical investigation plan and good clinical
practice. This training shall be verified and where necessary a rranged by
the sponsor and documented appropriately.
2.8. The clinical investigation report, signed by the investiga tor, shall contain a
critical evaluation of all the data collected during the clinic al investigation,
and shall include any negative findings. ▼B
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ANNEX XV
CLINICAL INVESTIGATIONS
CHAPTER I
GENERAL REQUIREMENTS
1. Ethical principles
Each step in the clinical investigation, from the initial consi deration of the
need for and justification of the study to the publication of t he results, ...
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CHAPTER II
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL
INVESTIGATION
For investigational devices covered by Article 62, the sponsor shall draw up and
submit the application in accordance with Article 70 accompanie d by the
following documents:
1. Application form
The application form shall be duly filled in, containing inform ation
regarding:
1.1. name, address and contact details of the sponsor and, if a pplicable, name,
address and contact details of its contact person or legal repr esentative in
accordance with Article 62(2) established in the Union;
1.2. if different from those in Section 1.1, name, address and contact details of
the manufacturer of the device intended for clinical investigat ion and, if
applicable, of its authorised representative;
1.3. title of the clinical investigation;
1.4. status of the clinical investigation application (i.e. fir st submission, resub
mission, significant amendment);
1.5. details and/or reference to the clinical evaluation plan;
1.6. If the application is a resubmission with regard to a devi ce for which an
application has been already submitted, the date or dates and r eference
number or numbers of the earlier application or in the case of significant
amendment, reference to the original application. The sponsor s hall
identify all of the changes from the previous application toget her with a
rationale for those changes, in particular, whether any changes have been
made to address conclusions of previous competent authority or ethics
committee reviews;
1.7. if the application is submitted in parallel with an applic ation for a clinical
trial in accordance with Regulation (EU) No 536/2014, reference to the
official registration number of the clinical trial;
1.8. identification of the Member States and third countries in which the
clinical investigation is to be conducted as part of a multicen tre or multi
national study at the time of application;
1.9. a brief description of the investigational device, its cla ssification and other
information necessary for the identification of the device and device type;
1.10. information as to whether the device incorporates a medic inal substance,
including a human blood or plasma derivative or whether it is m anu
factured utilising non-viable tissues or cells of human or anim al origin,
or their derivatives;
1.11. summary of the clinical investigation plan including the objective or
objectives of the clinical investigation, the number and gender of
subjects, criteria for subject selection, whether there are sub jects under
18 years of age, design of the investigation such as controlled and/or
randomised studies, planned dates of commencement and of comple tion
of the clinical investigation;
1.12. if applicable, information regarding a comparator device, its classification
and other information necessary for the identification of the c omparator
device; ▼B
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CHAPTER II
DOCUMENTATION REGARDING THE APPLICATION FOR CLINICAL
INVESTIGATION
For investigational devices covered by Article 62, the sponsor shall draw up and
submit the application in accordance with Article 70 accompanie d by the
following docu...
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List and explain the regulatory requirements for medical devices.
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1.13. evidence from the sponsor that the clinical investigator and the investi
gational site are capable of conducting the clinical investigat ion in
accordance with the clinical investigation plan;
1.14. details of the anticipated start date and duration of the investigation;
1.15. details to identify the notified body, if already involve d at the stage of
application for a clinical investigation;
1.16. confirmation that the sponsor is aware that the competent authority may
contact the ethics committee that is assessing or has assessed the appli
cation; and
1.17. the statement referred to in Section 4.1.
2. Investigator's Brochure
The investigator's brochure (IB) shall contain the clinical and non-clinical
information on the investigational device that is relevant for the investi
gation and available at the time of application. Any updates to the IB or
other relevant information that is newly available shall be bro ught to the
attention of the investigators in a timely manner. The IB shall be clearly
identified and contain in particular the following information:
2.1. Identification and description of the device, including in formation on the
intended purpose, the risk classification and applicable classi fication rule
pursuant to Annex VIII, design and manufacturing of the device and
reference to previous and similar generations of the device.
2.2. Manufacturer's instructions for installation, maintenance, maintaining
hygiene standards and for use, including storage and handling
requirements, as well as, to the extent that such information i s available,
information to be placed on the label, and instructions for use to be
provided with the device when placed on the market. In addition ,
information relating to any relevant training required.
2.3. Pre-clinical evaluation based on relevant pre-clinical tes ting and experi
mental data, in particular regarding in-design calculations, in vitro tests, ex
vivo tests, animal tests, mechanical or electrical tests, reliabili ty tests,
sterilisation validation, software verification and validation, performance
tests, evaluation of biocompatibility and biological safety, as applicable.
2.4. Existing clinical data, in particular:
— from relevant scientific literature available relating to the safety,
performance, clinical benefits to patients, design characterist ics and
intended purpose of the device and/or of equivalent or similar devices;
— other relevant clinical data available relating to the safety ,
performance, clinical benefits to patients, design characterist ics and
intended purpose of equivalent or similar devices of the same m anu
facturer, including length of time on the market and a review o f
performance, clinical benefit and safety-related issues and any
corrective actions taken.
▼C1
2.5. Summary of the benefit-risk analysis and the risk manageme nt, including
information regarding known or foreseeable risks, any undesirab le
side-effects, contraindications and warnings. ▼B
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1.13. evidence from the sponsor that the clinical investigator and the investi
gational site are capable of conducting the clinical investigat ion in
accordance with the clinical investigation plan;
1.14. details of the anticipated start date and du...
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2.6. In the case of devices that incorporate a medicinal substa nce, including a
human blood or plasma derivative or devices manufactured utilis ing
non-viable tissues or cells of human or animal origin, or their derivatives,
detailed information on the medicinal substance or on the tissu es, cells or
their derivatives, and on the compliance with the relevant gene ral safety
and performance requirements and the specific risk management i n
relation to the substance or tissues, cells or their derivative s, as well as
evidence for the added value of incorporation of such constitue nts in
relation to the clinical benefit and/or safety of the device.
2.7. A list detailing the fulfilment of the relevant general sa fety and
performance requirements set out in Annex I, including the stan dards
and CS applied, in full or in part, as well as a description of the
solutions for fulfilling the relevant general safety and perfor mance
requirements, in so far as those standards and CS have not or h ave
only been partly fulfilled or are lacking.
2.8. A detailed description of the clinical procedures and diag nostic tests used
in the course of the clinical investigation and in particular i nformation on
any deviation from normal clinical practice.
3. Clinical Investigation Plan
The clinical investigation plan (CIP) shall set out the rationa le, objectives,
design methodology, monitoring, conduct, record-keeping and the method
of analysis for the clinical investigation. It shall contain in particular the
information as laid down in this Annex. If part of this informa tion is
submitted in a separate document, it shall be referenced in the CIP.
3.1. General
3.1.1. Single identification number of the clinical investigati on, as referred to in
Article 70(1).
3.1.2. Identification of the sponsor — name, address and contac t details of the
sponsor and, where applicable, the name, address and contact de tails of
the sponsor's contact person or legal representative in accorda nce with
Article 62(2) established in the Union.
3.1.3. Information on the principal investigator at each invest igational site, the
coordinating investigator for the investigation, the address de tails for each
investigational site and the emergency contact details for the principal
investigator at each site. The roles, responsibilities and qual ifications of
the various kinds of investigators shall be specified in the CI P.
3.1.4. A brief description of how the clinical investigation is financed and a brief
description of the agreement between the sponsor and the site.
3.1.5. Overall synopsis of the clinical investigation, in an of ficial Union
language determined by the Member State concerned.
3.2. Identification and description of the device, including it s intended purpose,
its manufacturer, its traceability, the target population, mate rials coming
into contact with the human body, the medical or surgical proce dures
involved in its use and the necessary training and experience f or its use,
background literature review, the current state of the art in c linical care in
the relevant field of application and the proposed benefits of the new
device. ▼B
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2.6. In the case of devices that incorporate a medicinal substa nce, including a
human blood or plasma derivative or devices manufactured utilis ing
non-viable tissues or cells of human or animal origin, or their derivatives,
detailed information on...
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Define the key term or concept related to medical device regulation.
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3.3. Risks and clinical benefits of the device to be examined, with justification
of the corresponding expected clinical outcomes in the clinical investi
gation plan.
3.4. Description of the relevance of the clinical investigation in the context of
the state of the art of clinical practice.
3.5. Objectives and hypotheses of the clinical investigation.
3.6. Design of the clinical investigation with evidence of its scientific
robustness and validity.
3.6.1. General information such as type of investigation with r ationale for
choosing it, for its endpoints and for its variables as set out in the
clinical evaluation plan.
3.6.2. Information on the investigational device, on any compar ator and on any
other device or medication to be used in the clinical investiga tion.
3.6.3. Information on subjects, selection criteria, size of inv estigation population,
representativeness of investigation population in relation to t arget popu
lation and, if applicable, information on vulnerable subjects i nvolved such
as children, pregnant women, immuno-compromised or, elderly sub jects.
3.6.4. Details of measures to be taken to minimise bias, such a s randomisation,
and management of potential confounding factors.
3.6.5. Description of the clinical procedures and diagnostic me thods relating to
the clinical investigation and in particular highlighting any d eviation from
normal clinical practice.
3.6.6. Monitoring plan.
3.7. Statistical considerations, with justification, including a power calculation
for the sample size, if applicable.
3.8. Data management.
3.9. Information about any amendments to the CIP.
3.10. Policy regarding follow-up and management of any deviatio ns from the
CIP at the investigational site and clear prohibition of use of waivers from
the CIP.
3.11. Accountability regarding the device, in particular contro l of access to the
device, follow-up in relation to the device used in the clinica l investigation
and the return of unused, expired or malfunctioning devices.
3.12. Statement of compliance with the recognised ethical princ iples for medical
research involving humans, and the principles of good clinical practice in
the field of clinical investigations of devices, as well as wit h the applicable
regulatory requirements.
3.13. Description of the Informed consent process.
3.14. Safety reporting, including definitions of adverse events and serious
adverse events, device deficiencies, procedures and timelines f or reporting. ▼B
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3.3. Risks and clinical benefits of the device to be examined, with justification
of the corresponding expected clinical outcomes in the clinical investi
gation plan.
3.4. Description of the relevance of the clinical investigation in the context o...
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3.15. Criteria and procedures for follow-up of subjects followi ng the end,
temporary halt or early termination of an investigation, for fo llow-up of
subjects who have withdrawn their consent and procedures for su bjects
lost to follow-up. Such procedures shall for implantable device s, cover as
a minimum traceability.
3.16. A description of the arrangements for taking care of the subjects after their
participation in the clinical investigation has ended, where su ch additional
care is necessary because of the subjects' participation in the clinical
investigation and where it differs from that normally expected for the
medical condition in question.
3.17. Policy as regards the establishment of the clinical inves tigation report and
publication of results in accordance with the legal requirement s and the
ethical principles referred to in Section 1 of Chapter I.
3.18. List of the technical and functional features of the devi ce, with specific
mention of those covered by the investigation.
3.19. Bibliography.
4. Other information
4.1. A signed statement by the natural or legal person responsi ble for the
manufacture of the investigational device that the device in qu estion
conforms to the general safety and performance requirements apa rt from
the aspects covered by the clinical investigation and that, wit h regard to
those aspects, every precaution has been taken to protect the h ealth and
safety of the subject.
4.2. Where applicable according to national law, copy of the op inion or
opinions of the ethics committee or committees concerned. Where
according to national law the opinion or opinions of the ethics
committee or committees is not required at the time of the subm ission
of the application, a copy of the opinion or opinions shall be submitted as
soon as available.
4.3. Proof of insurance cover or indemnification of subjects in case of injury,
pursuant to Article 69 and the corresponding national law.
4.4. Documents to be used to obtain informed consent, including the patient
information sheet and the informed consent document.
4.5. Description of the arrangements to comply with the applica ble rules on the
protection and confidentiality of personal data, in particular:
— organisational and technical arrangements that will be implem ented to
avoid unauthorised access, disclosure, dissemination, alteratio n or loss
of information and personal data processed;
— a description of measures that will be implemented to ensure confi
dentiality of records and personal data of subjects; and
— a description of measures that will be implemented in case of a data
security breach in order to mitigate the possible adverse effec ts.
4.6. Full details of the available technical documentation, for example detailed
risk analysis/management documentation or specific test reports , shall,
upon request, be submitted to the competent authority reviewing an
application. ▼B
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3.15. Criteria and procedures for follow-up of subjects followi ng the end,
temporary halt or early termination of an investigation, for fo llow-up of
subjects who have withdrawn their consent and procedures for su bjects
lost to follow-up. Such proc...
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CHAPTER III
OTHER OBLIGATIONS OF THE SPONSOR
1. The sponsor shall undertake to keep available for the compet ent national
authorities any documentation necessary to provide evidence for the docu
mentation referred to in Chapter II of this Annex. If the spons or is not the
natural or legal person responsible for the manufacture of the investi
gational device, that obligation may be fulfilled by that perso n on
behalf of the sponsor.
2. The Sponsor shall have an agreement in place to ensure that any serious
adverse events or any other event as referred to in Article 80( 2) are
reported by the investigator or investigators to the sponsor in a timely
manner.
3. The documentation mentioned in this Annex shall be kept for a period of
at least 10 years after the clinical investigation with the dev ice in question
has ended, or, in the event that the device is subsequently pla ced on the
market, at least 10 years after the last device has been placed on the
market. In the case of implantable devices, the period shall be at least
15 years.
Each Member State shall require that this documentation is kept at the
disposal of the competent authorities for the period referred t o in the first
subparagraph in case the sponsor, or its contact person or lega l represen
tative as referred to in Article 62(2) established within its t erritory, goes
bankrupt or ceases its activity prior to the end of this period .
4. The Sponsor shall appoint a monitor that is independent from the investi
gational site to ensure that the investigation is conducted in accordance
with the CIP, the principles of good clinical practice and this Regulation.
5. The Sponsor shall complete the follow-up of investigation su bjects.
6. The Sponsor shall provide evidence that the investigation is being
conducted in line with good clinical practice, for instance thr ough
internal or external inspection.
7. The Sponsor shall prepare a clinical investigation report wh ich includes at
least the following:
— Cover/introductory page or pages indicating the title of the investi
gation, the investigational device, the single identification n umber,
the CIP number and the details with signatures of the coordinat ing
investigators and the principal investigators from each investi gational
site.
— Details of the author and date of the report.
— A summary of the investigation covering the title, purpose of the
investigation, description of the investigation, investigationa l design
and methods used, the results of the investigation and conclusi on of
the investigation. The completion date of the investigation, an d in
particular details of early termination, temporary halts or sus pensions
of investigations.
— Investigational device description, in particular clearly def ined
intended purpose. ▼B
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CHAPTER III
OTHER OBLIGATIONS OF THE SPONSOR
1. The sponsor shall undertake to keep available for the compet ent national
authorities any documentation necessary to provide evidence for the docu
mentation referred to in Chapter II of this Annex. ...
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Summarize the requirements and procedures for conducting clinical investigations on medical devices.
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— A summary of the clinical investigation plan covering objecti ves,
design, ethical aspects, monitoring and quality measures, selec tion
criteria, target patient populations, sample size, treatment sc hedules,
follow-up duration, concomitant treatments, statistical plan, i ncluding
hypothesis, sample size calculation and analysis methods, as we ll as a
justification.
— Results of the clinical investigation covering, with rational e and justifi
cation, subject demographics, analysis of results related to ch osen
endpoints, details of subgroup analysis, as well as compliance with
the CIP, and covering follow-up of missing data and of patients with
drawing from the clinical investigation, or lost to follow-up.
— Summary of serious adverse events, adverse device effects, de vice
deficiencies and any relevant corrective actions.
— Discussion and overall conclusions covering safety and perfor mance
results, assessment of risks and clinical benefits, discussion of clinical
relevance in accordance with clinical state of the art, any spe cific
precautions for specific patient populations, implications for the inves
tigational device, limitations of the investigation. ▼B
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— A summary of the clinical investigation plan covering objecti ves,
design, ethical aspects, monitoring and quality measures, selec tion
criteria, target patient populations, sample size, treatment sc hedules,
follow-up duration, concomitant treatme...
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Define the key term or concept related to medical device regulation.
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ANNEX XVI
LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED
MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
1. Contact lenses or other items intended to be introduced into or onto the eye.
2. Products intended to be totally or partially introduced into the human body
through surgically invasive means for the purpose of modifying the anatomy
or fixation of body parts with the exception of tattooing produ cts and
piercings.
3. Substances, combinations of substances, or items intended to be used for
facial or other dermal or mucous membrane filling by subcutaneo us,
submucous or intradermal injection or other introduction, exclu ding those
for tattooing.
4. Equipment intended to be used to reduce, remove or destroy a dipose tissue,
such as equipment for liposuction, lipolysis or lipoplasty.
5. High intensity electromagnetic radiation (e.g. infra-red, vi sible light and
ultra-violet) emitting equipment intended for use on the human body,
including coherent and non-coherent sources, monochromatic and broad
spectrum, such as lasers and intense pulsed light equipment, fo r skin resur
facing, tattoo or hair removal or other skin treatment.
6. Equipment intended for brain stimulation that apply electric al currents or
magnetic or electromagnetic fields that penetrate the cranium t o modify
neuronal activity in the brain. ▼B
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ANNEX XVI
LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED
MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
1. Contact lenses or other items intended to be introduced into or onto the eye.
2. Products intended to be totally or partially introduced into...
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ANNEX XVII
CORRELATION TABLE
Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation
Article 1(1) Article 1(1) Article 1(1)
Article 1(2) Article 1(2) Article 2
Article 1(3) Article 1(3) first subparagraph Article 1(9) first subparagraph
— Article 1(3) second subparagraph Article 1(9) second subparagraph
Article 1(4) and (4a) Article 1(4) and (4a) Article 1(8) first subparagraph
Article 1(5) Article 1(7) Article 1(11)
Article 1(6) Article 1(5) Article 1(6)
— Article 1(6) —
— Article 1(8) Article 1(13)
Article 2 Article 2 Article 5(1)
Article 3 first paragraph Article 3 first paragraph Article 5(2)
Article 3 second paragraph Article 3 second paragraph Article 1(12)
Article 4(1) Article 4(1) Article 24
Article 4(2) Article 4(2) Article 21(1) and (2)
Article 4(3) Article 4(3) Article 21(3)
Article 4(4) Article 4(4) Article 10(11)
Article 4(5)(a) Article 4(5) first subparagraph Article 20(6)
Article 4(5)(b) Article 4(5) second subparagraph —
Article 5(1) Article 5(1) Article 8(1)
Article 5(2) Article 5(2) Article 8(2)
Article 6(1) Articles 5(3) and 6 —
Article 6(2) Article 7(1) Article 114
Article 7 Article 8 Articles 94 to 97
— Article 9 Article 51
Article 8(1) Article 10(1) Articles 87(1) and 89 (2)
Article 8(2) Article 10(2) Article 87(10) and Article 87(11) first
subparagraph
Article 8(3) Article 10(3) Article 89(7)
Article 8(4) Article 10(4) Article 91
Article 9(1) Article 11(1) Article 52(3) ▼B
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ANNEX XVII
CORRELATION TABLE
Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation
Article 1(1) Article 1(1) Article 1(1)
Article 1(2) Article 1(2) Article 2
Article 1(3) Article 1(3) first subparagraph Article 1(9) ...
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Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation
— Article 11(2) Article 52(6)
— Article 11(3) Article 52(4) and (5)
— Article 11(4) —
— Article 11(5) Article 52(7)
Article 9(2) Article 11 (6) Article 52(8)
Article 9(3) Article 11(8) Article 11(3)
Article 9(4) Article 11(12) Article 52(12)
Article 9(5) Article 11(7) —
Article 9(6) Article 11(9) Article 53(1)
Article 9(7) Article 11(10) Article 53(4)
Article 9(8) Article 11(11) Article 56(2)
Article 9(9) Article 11(13) Article 59
Article 9(10) Article 11(14) Article 4(5) and Article 122 third
paragraph
— Article 12 Article 22
— Article 12a Article 17
Article 9a(1) first indent Article 13(1)(c) —
Article 9a(1) second indent Article 13(1)(d) Article 4(1)
— Article 13(1)(a) Article 51(3)(a) and Article 51(6)
— Article 13(1)(b) Article 51(3)(b) and Article 51(6)
Article 10 Article 15 Articles 62 to 82
Article 10a(1), second sentence of
Article 10a(2) and Article 10a(3) Article 14(1), second sentence of
Article 14(2) and Article 14(3) Articles 29(4), 30 and 31
Article 10a(2), first sentence Article 14(2) first sentence Article 11(1)
Article 10b Article 14a Articles 33 and 34
Article 10c Article 14b Article 98
Article 11(1) Article 16(1) Articles 42 and 43
Article 11(2) Article 16(2) Article 36
Article 11(3) Article 16(3) Article 46(4)
Article 11(4) Article 16(4) —
Article 11(5) Article 16(5) Article 56(5)
Article 11(6) Article 16(6) Article 56(4)
Article 11(7) Article 16(7) Articles 38(2) and 44(2) ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 232
Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation
— Article 11(2) Article 52(6)
— Article 11(3) Article 52(4) and (5)
— Article 11(4) —
— Article 11(5) Article 52(7)
Article 9(2) Article 11 (6) Article 52(8)
Ar...
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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 — 233
Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation
Article 12 Article 17 Article 20
Article 13 Article 18 Articles 94 to 97
Article 14 Article 19 Article 99
Article 15 Article 20 Article 109
Article 15a Article 20a Article 102
Article 16 Article 22 —
Article 17 Article 23 —
— Article 21 — ▼B
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Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 233
Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation
Article 12 Article 17 Article 20
Article 13 Article 18 Articles 94 to 97
Article 14 Article 19 Article 99
Article 15 Article 20 Article 109
Article 15a Article...
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