With Commission Decision (EU) 2025/2371 of 27 November 2025, the European Commission has initiated a six-month transition period that will make the first four EUDAMED modules mandatory. To ensure full compliance by 28 May 2026, economic operators concerned are already required to begin the necessary registrations within the platform.
EUDAMED is the EU’s central database for medical devices and IVDs, established under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Until now, the platform’s incomplete functionality meant that many registration obligations were fulfilled via national systems.
With this Decision, the Commission confirms the functionality of the following modules:
• Registration of manufacturers, authorised representatives and importers;
• UDI database and device registration;
• Notified Bodies and certificates of conformity;
• Market surveillance.
The start of the transition period makes the use of these modules mandatory from 28 May 2026.
The following modules are still pending confirmation of full functionality:
• Clinical investigations and performance studies;
• Vigilance and post-market surveillance
Until further notice, national requirements will continue to apply for these areas.
PRINEOS will continue to monitor regulatory developments and support companies in aligning their operations with the new European requirements.