Home » EU Device Regulation Includes Premarket Scrutiny Mechanism, Industry Vows Pushback
EU Device Regulation Includes Premarket Scrutiny Mechanism, Industry Vows Pushback
October 2, 2012
As widely anticipated in the wake of the PIP breast implant and metal-on-metal hip scandals, the European Commission is proposing that high-risk medical devices undergo more rigorous premarket scrutiny, but not on the level required by the U.S. Food and Drug Administration (FDA). Includes the full text of Q&A on Proposed EU Medical Device, IVD Regulations.
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