SNITEM (French medical device industry association) wants France to modify high-risk proposals
This article was originally published in Clinica
The French medical device industry association, SNITEM, has asked AFSSAPS, the French Agency for Healthcare Product Safety, to modify its draft proposals for regulating high-risk medical devices. It is concerned that as the proposals stand, the agency is moving towards the introduction of a second CE-marking procedure and unnecessarily duplicating work already done by notified bodies.
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