28.11.2025
To the attention of all interested parties
The European Commission published in the Official Journal of the European Union Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices (EUDAMED):
https://eur-lex.europa.eu/legal-content/RO/TXT/PDF/?uri=OJ:L_202502371
This confirms that the following electronic systems included in the EUDAMED are functional and meet the functional specifications mentioned in Article 34(2) of Regulation (EU) 2017/745:
• the electronic system for the registration of economic operators (Actor registration) – referred to in Article 30 of Regulation (EU) 2017/745(MDR) and in Article 27 of Regulation (EU) 2017/746(IVDR);
• the UDI database and the electronic system for device registration (UDI/Device registration) – referred to in Articles 28 and 29 of Regulation (EU) 2017/745(MDR) and in Articles 25 and 26 of Regulation (EU) 2017/746(IVDR);
• the electronic system for notified bodies and certificates (Notified Bodies and Certificates module) – referred to in Article 57 of Regulation (EU) 2017/745(MDR) and in Article 52 of Regulation (EU) 2017/746(IVDR);
• the electronic market surveillance system (Market Surveillance) – referred to in Article 100 of Regulation (EU) 2017/745(MDR) and in Article 95 of Regulation (EU) 2017/746(IVDR).
The obligations and requirements related to the Eudamed apply from the date corresponding to a 6-month period from the date of the aforementioned publication (according to Article 123 of the MDR, Article 113 of the IVDR), namely from 28 May 2026.