EUDAMED’s rollout has a boundary medtech teams cannot afford to blur

EUDAMED is now a mandatory part of several European medical-device processes, but its rollout is not complete. The European Commission’s overview says four modules became mandatory on 28 May 2026. It separately lists vigilance and post-market surveillance, and clinical investigations and performance studies, as unfinished modules.

The four mandatory modules concern actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. The last of these serves competent authorities and the Commission. It should not be confused with a manufacturer’s post-market surveillance process simply because the names sound similar.

This boundary is particularly relevant during the 6-8 October European PMS and Vigilance conference in Amsterdam. The meeting brings monitoring and vigilance specialists together; it does not change the legal status of EUDAMED modules. We checked the Commission’s implementation overview on 4 October.

A platform milestone is not the whole lifecycle

A manufacturer needs to connect information about a device with experience after it reaches users. Registration establishes identifiable records; monitoring asks what subsequent evidence says about performance and safety. Treating the former as a substitute for the latter would leave a basic information gap.

MSSG.news’s organisational reading is that regulatory, quality and technical teams need one consistent device identity and a shared escalation process. A change in database obligations can expose weaknesses in ownership and data quality that were already present internally.