European medical device makers seek a compromise in new legislation

January 31, 2013 by MassDevice staff

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.


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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