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EU Regulatory Roundup, April 2019: Progress Toward Regulation Implementation Steps Up

 
• By Amanda Maxwell

April 2019 was seemingly a bumper month in terms of the amount of progress toward implementation of the EU Medical Device and IVD Regulations. There is now, finally, a sense that the sector is moving towards implementation of the MDR. But with so much left until so late, will enough progress be achieved in the time left?

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One of the most surprising – and positive – pieces of EU regulatory news in April was that fully 47 notified bodies have now applied to the European Commission to be designated under the new Medical Device and IVD Regulations. (Also see "Sharp Rise In EU MDR Notified Body Applicants Is Pleasant Surprise" - Medtech Insight, 24 April, 2019.)

What is more, almost all the applications are to audit products under the full scope of the relevant Regulation.

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