EU - First Eudamed modules declared functional

The EU has published Commission Decision (EU) 2025/2371 in the EU Official Journal that declares the first for modules of Eudamed as functional. This triggers the start of a 6 month transition period for manufacturers until the mandatory use of the modules that starts on 2026-05-28.

The EU also published an updated Roadmap that shows that the vigilance module will again be delayed compared to previous versions of the document.