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Scrip Regulatory Affairs
European device classification guidance "skips contentious issues"
02 July 2010
Vibha Sharma

The European Commission's latest revision of its guidance on the classification of medical devices fails to address some controversial issues, according to medtech industry association Eucomed and standards body BSI1-3.

Eucomed says that it "regrets" that some contentious issues, such as the classification of haemostatic sealants and other products, "have been left open" in the revised guideline, MEDDEV 2...

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