EUDAMED: 1st four fully functional modules

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The European Commission has officially declared that 4 modules within the European Database on Medical Devices (EUDAMED) are now fully functional and meet all required specifications under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746

This milestone marks a significant step toward enhanced transparency, traceability, and regulatory compliance across the EU medical device sector. The systems now operational include:

Registration of economic operators
UDI database and device registration
Notified bodies and certificates
Market surveillance

With the decision (EU) 2025/2371 published in the Official Journal on 27 November 2025, the transition periods for mandatory use of these systems have officially begun.

The mandatory implementation date for EUDAMED for these first four modules is set for May 28, 2026.

While waiting for May 28, 2026, it is recommended to prepare for the use of the EUDAMED database by familiarizing yourself with its interface and checking the quality of the data to be entered.

This achievement reinforces the EU’s commitment to patient safety and streamlined regulatory processes.

DOWNLOAD THE IMPLEMENTING DECISION (EU) 2025/2371