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Surprise EU Document Emerges With Proposal For European Medical Device Office

 
• By Amanda Maxwell

Industry will be well acquainted with the proposal's content since it reflects its own work on the much-needed further development of the Medical Device Regulation

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Proposed measures to fix the MDR are swiftly being aligned into a vital proposal that could be taken up by the European Commission • Source: Shutterstock

The European Parliament has drafted a proposal for an amending regulation to the Medical Device Regulation laying out – among other things - how a new European Medical Device Office should be created and what its role should be.

The Parliament has also suggested specific procedures for conformity assessment of orphan and innovative

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