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RAPS Ohio Local Networking Group Event: EU Medical Device Regulation (MDR)

February 22 @ 5:30 pm - 8:00 pm

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

Location:

Case Western Reserve University

Biomedical Engineering Department

Nord Hall Room 410, 309 Wickenden Building

10900 Euclid Avenue

Cleveland, OH 44106

Click here to learn more and register.

Venue

Case Western Reserve University
10900 Euclid Ave
Cleveland, OH 44106 United States
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Phone:
(216) 368-2000
Website:
http://www.case.edu/