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Proposal for a Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

Origin/Publisher:

EU Kommission

Content:
This Regulation establishes lays down rules to be complied with by medical devices and accessories to medical devices that are placed concerning the placing on the market, making available on the market or putting into service of medical devices and accessories to medical devices for human use in the Union for human use. This regulation also applies to clinical investigations on medical devices conducted in the Union.

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