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EU Commission Proposes Much Anticipated MDR and IVDR Revision

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The EU Commission has published its 170-page proposal on revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) on 16 December 2025, which can be accessed here. After MDR and IVDR became applicable in 2021/2022, medical device manufacturers and Notified Bodies continued to struggle with the challenges resulting from the new regulatory framework….
By: A&O Shearman

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