New EU Medical Device Regulations – What’s the Impact?
OVERVIEW Partially as a result of the Poly Implant Prothèse breast implant scandal, where a French manufacturer substituted approved medical-grade silicone with industrial-grade silicone that ruptured causing a variety of serious medical implants up to and including death, the European Commission began developing changes to their Medical Device Directives to prevent this type of an issue from happening again. The changes resulted in the drafting of a totally new Medical Device Regulation that was fully released this past February. The new EMDR is the most extensive medical device regulation Europe has seen since the 1990’s. Industry experts are concerned that regulations will increase costs and eliminate early access to device innovations that patients in Europe currently experience. Understanding the contents of this regulation and its implications is crucial to the effective design, development, marketing, and utilization of medical devices in the EU. European Medic...