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Basic seminar on medical devices You are here: - Workshops and seminars - Basic seminar on medical devices Description Medical device manufacturers operate in a field that is subject to a number of legal regulations. It is important that employees in a variety of roles are confident in their knowledge of the basics of medical device legislation, as this enables them to assess decisions and their consequences accurately. This seminar covers the basics of medical devices that previously fell within the remit of EC Directives 93/42/EEC and 90/385/EEC and now fall under the remit of European Regulation (EU) 2017/745. It is intended to provide an insight into the most important areas within the legal requirements for medical devices in Europe and establish a link to practical work. By providing an informative overview of Europe and beyond, this seminar improves participants' understanding of the varied regulatory approaches in the medical device field. This seminar is suitable as initial training for new employees, as well as further training or a refresher course for employees who have been working in this sector for some time. Contact Person Goals This seminar explains the basics of medical device regulations in Europe and sets out the differences between medical devices and products from other legal areas, such as medicinal products and cosmetics. It explores the most important aspects of classification and conformity assessment in accordance with the applicable EC directives and Regulation (EU) 2017/745 on medical devices. Selected examples of regulatory processes in non-EU countries provide an insight into registration and authorisation procedures around the world. Participants will gain a deeper understanding of the fundamental terms and processes in the field of medical device registration and authorisation. Seminar content - What are medical devices? Differences to other legal areas (cosmetics, medicinal products, combination products) - Regulation (EU) 2017/745 on medical devices with existing transitional regulations relating to Directives 93/42/EEC on medical devices and 90/385/EEC on active implants - German Medical Device Law Implementation Act (MPDG) - Classification and CE marking of medical devices (modules for conformity assessment) - Certification and registration - Post-market surveillance, market surveillance - Responsibilities in Germany and at European level (higher federal authorities, national authorities, notified bodies) - A look at the world outside the EU: Regulatory requirements for medical devices in selected countries Target group / seminar duration and certificate Basic seminar for employees completing training in the field of regulatory affairs for medical devices, as well as employees from other sectors, such as purchasing, quality assurance, development and product management, who require a good understanding of the basic principles of medical device legislation. Prior knowledge is not necessary. The content is presented over the course of a one-day seminar. The participants receive a certificate of attendance and, on request, materials for participants in digital form. Seminar inquiry
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Kako bi se osigurala kontinuirana usklađenost sa direktivom vijeća 93/42/EEC o medicinskim proizvodima, Europska Komisija je 24.09.2013 god stavila novi regulatorni zahtjev pred prijavljena tijela i proizvođače medicinskih proizvoda klase rizika III o provedbi nenajavljenih audita. Slijedom novog regulatornog zahtjeva, dana 22.02.2017 god prijavljeno tijelo SGS UK je izvršilo nenajavljeni audit u Instrumentariji. Prijevaljeno tijelo je utvrdilo kako su svi procesi u skladu sa zahtjevima direktive 93/42/EEC te da je sustav upravljanja u potpunosti u skladu sa regulatornim zahtjevima ISO [...]