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European Commission Issues New Medical Device Guidelines

Thursday, September 27, 2012  
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The European Commission issued proposed measures recently that called for moving towards a centralized pre-market authorization system similar to the United States.

The measures are currently being examined, but many stakeholders have already raised concerns that they would delay patient access to medical technologies and unnecessarily thwart innovation in Europe.

"The existing regulatory framework has demonstrated its merits but it has been in place for 20 years and like any regulatory regime dealing with innovative products, needs revision," according to the Commission's proposal. "Moreover, it has recently come under harsh criticism in the media and the political arena."

Special attention was paid to a proposed measure known as "scrutiny procedure," where a central panel of advisors would monitor the various assessment agencies that currently oversee medical device control in the European Union.

MDMA continues to work with FDA and our partners to address concerns with regulatory bodies as they examine their processes to ensure they are reasonable.