Medical devices: EU Commission proposes MDR and IVDR revision

The EU Commission 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 December 16, 2025. 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. The transitional periods under the MDR and IVDR have been extended several times due to ongoing capacity... By: A&O Shearman