Regulatory updates

News and guidance on EU and UK regulations for medical devices, IVDs and general products. The newest posts are shown first.

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Posts tagged EUDAMED

EUDAMED becomes mandatory on 28 May 2026: what manufacturers need to do now

EUDAMED's first four modules become mandatory on 28 May 2026. What manufacturers, authorised representatives and importers must do now.

EUDAMEDJonathan PhillipsMay 5, 2026UDAMED, EU MDR, IVDR, medical devices, regulatory compliance, Northern Ireland, Windsor Framework, Authorised Representative, PRRC, UK Responsible Person, EUDAMEDComment