EU Device Regulation Includes Premarket Scrutiny Mechanism, Industry Vows Pushback
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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