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European medical device makers seek a compromise in new legislation

Thu, 01/31/2013 - 2:31pm
Mass Device

European medical device lobby Eucomed cedes that European medical device review needs an overhaul, but warns that a newly proposed "scrutiny panel" system without proper checks will hamper innovation without enhancing patient safety.

Eucomed

European medical device makers continue to fight back against proposed healthcare regulations that would add a new layer of pre-market review to the medtech approval pathway.

Device lobby Eucomed issued a handful of recommendations in response to the European Commission's "scrutiny panel" model, which would designate a central FDA-like body to review medical devices after they had already gone through the existing certification process.

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