Wednesday, October 3, 2012

EU Device Regulation Revision Includes Premarket Scrutiny Mechanism, UDI

FDAnews Device Daily Bulletin

Oct. 2, 2012 | Vol. 9 No. 193

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. The proposed regulations, unveiled Wednesday, are already generating industry pushback over concerns they will delay marketing authorization of novel medical technologies.

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