Join the RAPS Ohio Local Networking Group for a networking event featuring insightful discussion on EU Medical Device Regulation (MDR). This is a free event.
Presentation Title: EU Medical Device Regulation (MDR)
- After almost a decade of development and negotiation, new regulations will help advances in medical device technology and include:
- Reclassification of some technologies and the inclusion of others that were previously exempted from regulation, as well as classification of software
- Increase in the oversight of the medical device industry through enhanced authority of the Notified Bodies (NB) and independent review by the competent authorities of NB certification of certain high-risk devices
- Elevated clinical requirements for higher risk devices
- Imposition of more extensive post-market surveillance for many devices
- Higher focus on control of a manufacturer’s supply chain and the inclusion of other entities, such as importers and distributors, under the regulation
Case Western Reserve University
Biomedical Engineering Department
Nord Hall Room 400, 309 Wickenden Building
10900 Euclid Avenue
Cleveland, OH 44106
Click here to learn more and register.