Mandatory Use of EUDAMED First Four Modules as of 28 May 2026
The European Commission has published Commission Decision (EU) 2025/2371 of 26 November 2025 in the Official Journal of the European Union on 27 November 2025. This decision confirms the functionality and compliance of the first four modules of the European Database on Medical Devices (EUDAMED) with the required specifications.
In accordance with the transitional provisions set out in Regulation (EU) 2024/1860, this publication initiates a six-month transition period. Consequently, as of 28 May 2026, the following EUDAMED modules will become mandatory:
- Actor Registration
- UDI/Device Registration
- Notified Bodies & Certificates
- Market Surveillance
Please ensure that your organization is registered as an economic operator in EUDAMED and has obtained a Single Registration Number (SRN). Each economic operator role requires a separate SRN. The roles are: manufacturer, authorised representative, importer and system/procedure pack producer.
Registration can be completed via the official website: MDR-Eudamed – Welcome to EUDAMED.
A user guide is available to assist with the registration process. Once your application is successfully approved, you may begin registering your devices in the EUDAMED device module. Additional user guides are provided for registering both legacy devices and devices under the Regulation.
For further details, please refer to the official European Commission page: Overview – Public Health – European Commission.
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