The Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) introduce the European Database on Medical Devices (EUDAMED) by Art. 33 MDR and Art. 30 IVDR. This database aims to enhance transparency, for example by improving access to information for the public and healthcare professionals. EUDAMED is composed of six modules as well as a public website.

1. Actor Registration
2. UDI/Device Registration
3. Notified Bodies and Certificates
4. Market Surveillance
5. Vigilance and Post-Market Surveillance
6. Clinical Investigations and Performance Studies

Starting from May 28, 2026, the use of the first four modules is mandatory for economic operators (manufacturers, authorised representatives, importers, system/procedure pack producers), notified bodies and competent authorities. The remaining two modules (Vigilance and Post-Market Surveillance, and Clinical Investigations and Performance Studies) are still under development.

Further information on the actor registration in EUDAMED can be found here.

EUDAMED can be accessed via the following links:

• Access for registered users who are subject to the registration/reporting obligations under the MDR/IVDR: https://webgate.ec.europa.eu/eudamed
• Public website: https://ec.europa.eu/tools/eudamed
• Questions and Answers on the gradual implementation of EUDAMED: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_eudamed-qa_en.pdf
• Documentation & training materials: https://webgate.ec.europa.eu/eudamed-help/en/welcome-to-the-eudamed-information-centre.html
• UDI Helpdesk: https://webgate.ec.europa.eu/udi-helpdesk/en/welcome-to-eu-udi-helpdesk.html

For support regarding EUDAMED, the following e‑mail address is available: SANTE-EUDAMED-SUPPORT@ec.europa.eu