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Heading For Crisis: The Upturn In EU Medtech Regulatory Output Is ‘Not Enough’ – MedTech Europe

 
• By Amanda Maxwell

There has been a flurry of EU Regulation implementation documents of late. The European Commission’s Rolling Plan is moving along, and there has been positive news of more notified body designation applications. But MedTech Europe still believes the sector is heading for a crisis  ̶  which member state authorities are aware of but won’t flag up, as Amanda Maxwell discovered in an exclusive interview with MTE’s Oliver Bisazza.

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Industry is pulling out all the stops when it comes to alerting the EU regulatory authorities that the sector is heading for a crisis in medtech product availability, linked to failures and delays in the implementation of the new EU medtech regulations, the MDR (2017/745) and IVDR (2017/746).

But the European Commission is continuing to assert that progress is being made, and is issuing an increasing number of...

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