Commission updates EUDAMED implementation time estimations

Further information has emerged from the Commission regarding the timelines for mandatory use of the six EUDAMED modules, shifting the estimations from the July 2025 timeline chart, which now includes an “Under review” note.

Further to the implementation of Regulation (EU) 2024/1860 regarding the gradual roll-out of the six EUDAMED modules and the November 2024 publication of a Q&A document, the current estimation is that the OJEU notice for the first four modules (Actor, UDI/Devices, NBs/Certificates, and Market Surveillance) will be appearing within the month of November 2025, meaning that mandatory use will commence in May 2026.

The next module to appear in the OJEU will be for Vigilance, which is now anticipated for Q1/Q2 2026 and thus mandatory from Q3/Q4 2026. The timescale for the final module, Clinical Investigation & Performance Studies, is still unclear, but OJEU publication not anticipated until 2027.

The Commission maintains comprehensive EUUDAMED information on its website.