Following the relevant decision dated 03/12/2024 Announcement
We inform you that the mandatory use of the four modules of the European Database for Medical Devices (Eudamed) that meet the operating specifications will start on May 28, 2026.
According to Decision (EU) 2025/2371, the following electronic systems included in the European Database on Medical Devices (Eudamed) are operational and meet the operating specifications:
(a) the electronic system for the registration of economic operators, referred to in Article 30 of Regulation (EU) 2017/745 and Article 27 of Regulation (EU) 2017/746;
(b) the UDI Database and the electronic system for the registration of devices referred to in Articles 28 and 29 of Regulation (EU) 2017/745 and Articles 25 and 26 of Regulation (EU) 2017/746;
(c) the electronic system for Notified Bodies and certificates, referred to in Article 57 of Regulation (EU) 2017/745 and Article 52 of Regulation (EU) 2017/746;
d) the electronic system for market surveillance, which is referred to in Article 100 of Regulation (EU) 2017/745 and in Article 95 of Regulation (EU) 2017/746.
Additional information is available on the European Commission website at the following links:
//health.ec.europa.eu/medical-devices-eudamed/overview_en
Product Evaluation Department
Department of Health Equipment Evaluation
