EC Publications
Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices; 16 December 2025 <link>
Commission Decision (EU) 2025/2371 of 26 November 2025 - Publication of the notice of functionality of the first four EUDAMED modules, triggering their mandatory use as of 28 May 2026 <link>
EC Press Releases
Questions and answers on simpler and more effective rules for medical devices; 16 December 2025 <link>
Factsheet: Better rules for medical devices, better outcomes for EU patients; 16 December 2025 <link>
Questions and answers on the European Biotech Act; 16 December 2025 <link>
Questions and answers on the EU Safe Hearts Plan; 16 December 2025 <link>
Implementing Act adopted by the EC - December 2025
Designating EU Reference Laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs) 16 December 2025 <link>
EC Published Initiatives
Medical devices - uniform application of the requirements for notified bodies; Deadline for public feedback: 23 January 2026 <link>
Medical Device Coordination Group (MDCG) endorsed guidance documents
MDCG documents present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the EU legislation <link>