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Home » EU Device Regulation Revision Includes Premarket Scrutiny Mechanism, UDI
EU Device Regulation Revision Includes Premarket Scrutiny Mechanism, UDI
September 28, 2012
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.