EUDAMED Registration Is Now Mandatory
Since 28 May 2026, EUDAMED, the European Database on Medical Devices, is mandatory.
For non-EU manufacturers, this is decisive: without a valid EUDAMED registration, devices can no longer be sold on the EU market.
What changed? Appointing an EU Authorised Representative is now compulsory and non-EU manufacturers can only complete EUDAMED regsitration through a verified EU Authorised Representative (AR).
How it works:
- You appoint an EU Authorised Representative.
- Your registration request is routed to that representative, who verifies your mandate.
- Next, the national authority validates your regsitraton and issues your Single Registration Number (SRN).
- Only with a valid SRN can you register devices, which must happen before they reach the market.
Deadlines:
- New devices: must be registered before being placed on the market. No grace period.
- Existing devices still being sold: must be registered within a 12-month transition (by late November 2026).
No SRN means no market access: authorities and distributors must reject non-compliant devices.
GSI-CERT acts as your EU Authorised Representative in Germany and manages the full process: legal representation under Art. 11 MDR/IVDR, EUDAMED actor and device registration, and all communication with the German authorities.