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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). The proposed regulations, unveiled Sept. 26, are already generating industry pushback over concerns they will delay marketing authorization of novel medical technologies.
International Medical Device Regulatory Monitor