On May 28, 2026, the six-month transition period following the European Commission’s declaration of functionality dated November 27, 2025, ended.
As of that date, the first four EUDAMED modules are mandatory for all market participants.
These modules are
- Actor registration
- UDI and product registration (UDI/Devices registration),
- Notified Bodies and Certificates
- Market Surveillance.
Anyone who previously used parallel national reporting channels or voluntary EUDAMED entries had to process the corresponding registrations and mandatory information via EUDAMED from this date. The Vigilance and Clinical Trials/Performance Studies modules are not yet mandatory ; their application will follow a separate functional explanation.
The European Commission provides the following information: The first four EUDAMED modules will be mandatory as of May 28, 2026 – Public Health