Impact of New Medical Device Regulation in European Union

Sridhar S, Venkatesh MP

Abstract

The European Union (EU) is responsible for the proposing and implementation of new regulations in EU, the european commission put first medical device directive (MDD) into the place in June 1993 under the council directive 93/42/EC, which is the first attempt to harmonize the medical device regulation which is marketed across EU member states, the medical device manufacturers were attracted to the EU device market because of faster approvals, less strict and more innovation friendly than US and the shorter time to market for medical device, but the recent medical device controversy like PIP breast implant and MoM hip implant devices created controversy within the public because of its adverse effects and there should be need for the formalized regulation to stringent the requirements for approval of the medical device i.e., for class 3 devices biocompatibility testing requirements which is in the new medical device regulation 2017/745/EC is amended from directive to regulation in European Parliment.