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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"We don't see this proposed extra layer as bringing anything significant to the game," Eucomed CEO Serge Bernasconi told during an interview in September. "In particular, when it relates to patient safety, fast access to technology for patients and further development of innovation in Europe, which has been fertile ground for developing innovations."

In response to the new proposal Eucomed today released a detailed position paper calling for checks and standards for existing "Notified Bodies" responsible for postmarket review, strengthening the current medtech review process in lieu of adding another layer.