Medical device and IVD companies have a firm date to work towards. Following Commission Decision (EU) 2025/2371, the first four modules of EUDAMED become mandatory from 28 May 2026 under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
What’s changing
The four modules are Actor registration, UDI and device registration, Notified Bodies and Certificates, and Market Surveillance. Every economic operator must complete Actor registration and obtain a Single Registration Number (SRN) before 28 May 2026. New devices placed on the EU market from that date must be registered in the UDI and Device module before they are placed, while devices already on the market (legacy devices) have until 28 November 2026 to be fully registered.
What to do now
Actor registration, gathering UDI data and preparing device records all take time, and the work tends to surface questions that are easier to resolve well before a deadline than on top of one. Treat 28 May 2026 as the finish line, not the starting point, and begin your registration now.
How MPCA can help
We support clients with medical device registration and the wider requirements of MDR and IVDR. We can help you register as an actor, organise your device data and plan the route to full EUDAMED compliance. See our regulatory affairs service page, and the FAMHP’s overview of the obligations from 28 May 2026.
This article is for general information and reflects the situation at the time of writing. Always consult the official EU and FAMHP publications for binding requirements.