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Devices & Diagnostics Letter
Oct. 1, 2012 | Vol. 39 No. 39
EU Device Regulation Revision Includes Premarket Scrutiny Mechanism, UDI
As widely anticipated in the wake of the PIP breast implant and metal-on-metal hip scandals, the European Commission is proposing that certain high-risk medical devices undergo more rigorous premarket scrutiny akin to that required by the FDA.
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