European Commission confirms functionality of EUDAMED first four modules
28 November 2025
On 27 November 2025, the European Commission published Decision (EU) 2025/2371, confirming the functionality of several electronic systems within the European Database for Medical Devices (EUDAMED). This marks the beginning of the transition phase for the new obligations and requirements related to these systems.
On 15 December 2022, the Commission published the updated functional specifications of EUDAMED (Version 7.2). An independent assessment, the results of which were presented on June 18, 2025, confirmed the functionality and compliance with these specifications. According to Decision (EU) 2025/2371, the following electronic systems integrated into the European Database for Medical Devices (EUDAMED) are confirmed to be functional and to meet the specifications as per Article 34(2) MDR:
- Registration of economic operators
- UDI database and product registration
- Notified bodies and certificates
- Market surveillance
The transition periods for the obligations and requirements of these systems will commence on the date of the decision’s release:
- As of 28 May 2026, all new MDR/IVDR products must be registered in EUDAMED prior to being placed on the market.
- New certificates in accordance with MDR/IVDR must also be entered into EUDAMED from this date.
- For “Legacy Devices” and products placed on the market before 28 May 2026, an extended registration period applies until 28 November 2026.
- Certificates issued before 28 May 2026 are to be entered into EUDAMED by 28 May 2027 at the latest.
This decision is a major milestone in enhancing the transparency and oversight of medical devices within the European Union. The implementation and use of the electronic systems of EUDAMED ensure that all relevant information is centrally available and meets the high safety requirements of the MDR and IVDR.
If you have any queries regarding EUDAMED or need assistance with registration, our experts will be happy to assist. Reach out and learn how we can help you!
