EU Regulatory Roundup, July 2023: Weighing Up The Impact Of The MDR Amending Regulation

July was a busy month for industry as the repercussions of the publication and enforcement on 20 March of the EU’s amending regulation to the Medical Device Regulation start to be really understood. 

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Now, just over four months after the publication of the amending regulation to the MDR, which brought extended compliance timelines for legacy products, the real benefits and outstanding issues are really beginning to be understood.

Notably, during July, the European Commission published a survey showing the number of certificates granted by and applications made to EU notified bodies designated under the MDR and IVDR. It...

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