Euro device makers cry 'nay' on FDA-like proposal for medtech review

September 26, 2012 by MassDevice staff

Medical device makers warn against new guidelines that would establish a central FDA-like body to oversee pre-market medtech review for the European Union.

European Commission flag

Medical device groups were quick to criticize the European Commission's newly released medical device regulatory guidelines, saying certain updates stall innovation rather than bolster safety.

European medical device lobbying group welcomed most of the proposed measures, but took exception to the so-called "scrutiny procedure," through with a central panel of advisors would monitor the various assessment agencies that currently oversee medical device control in the European Union.

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