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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

Merger and Acquisitions, partnership or work together
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 devices, among other far-reaching changes.

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