European Medical Device Regulation
The EU Medical Device Regulation (MDR) is far more complex than the Medical Device Directive (93/43/EEC) it replaces and presents new challenges. Strict new requirements for Clinical Data, risk management, postmark surveillance, and supplier management.
The EU MDR isn’t in effect until May 2020. Companies with limited resources and sizeable medical device portfolios often need help planning how and when to transition MDR.
The two-day course on the Medical Device Regulation 2017/745 with a focus on the requirements for Medical Device Manufacturers.
In this course, you will receive a general overview of the Medical Device Regulation, the Implementation Timelines, Paths to CE Mark, and a deep dive into the significant articles that affect medical device manufacturers.
Included in the presentation is a copy of the MDR, a gap analysis template, and a sample of the General Safety and Performance Requirements checklist with highlights of significant differences from the MDD Annex I Essential Requirements Checklist.
- Overview of the Medical Device Regulation
- Implementation timeline
- Paths to CE Mark
- Regulation structure overview
- Review of Significant Articles
- In-Depth Review and Discussion of Articles
- Review of Significant Annexes
- In-Depth Review and Discussion of Annexes
- Strategy for Deployment
- Significant Pitfalls to watch out for
- Unknowns – Still to be determined
- Tools and References