Workshop on Regulation (EU) 2017/745 on medical devices
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- Workshop on Regulation (EU) 2017/745 on medical devices
The transition period for Regulation (EU) 2017/745 on medical devices started on 26th May 2017. Its date of application was 26th May 2020, after the transition period had elapsed. In the intervening years, more and more provisions in this new regulation have come into force; authorities, notified bodies and manufacturers have been readying themselves for the next steps.
On a company-specific basis, the workshop considers the company's product range and is primarily designed for businesses that market medical devices under their own name. The additional roles that a company adopts as an actor (e.g. distributor, representative) are also included.
This workshop will explain the basics of the regulation and the most important changes and new aspects compared to Directive 93/42/EEC. This workshop is intended to provide participants with the opportunity to discuss company-specific regulations as a group and to ensure that their knowledge is up to date. It should enable the responsible teams within the company to introduce the next steps for implementing the regulation in a targeted manner.
- Overview of the provisions in the MDR, entirely new provisions and pending legal acts
- Fundamentals of placing products on the market and actors' obligations
- New responsibilities including the "person responsible for regulatory compliance"
- Fundamentals of conformity assessment and of classification, MDR classification regulations
- New and expanded requirements for QM systems, including processes for clinical evaluation and for post-market surveillance (PSUR, SSCP)
- Annex I MDR: General safety and performance requirements
- Technical documentation in accordance with Annex II and Annex III MDR
- Medical device registration, labelling, product identification (UDI, EUDAMED), traceability
- If applicable to the company's products: New processes for consultation and verifying the conformity assessment ("scrutiny")
Target group / seminar duration and certificate
This seminar is designed for employees in regulatory affairs and quality management. It requires thorough knowledge of Directive 93/42/EEC and its implementation. The workshop, in particular, offers an opportunity to discover the new features of the EU regulation compared to existing regulations.
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 physical or digital form.Seminar inquiry