EUDAMED, the European Database on Medical Devices is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
EUDAMED provides a living picture of the lifecycle of medical devices available in the European Union. It integrates different electronic systems to collate and process information about medical devices. EUDAMED aims to enhance overall transparency, including better access to information for public and healthcare professionals and to enhance coordination between the different Member States in the EU.
The Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 lays down the detailed arrangements necessary for the setting up and maintenance of EUDAMED.
EUDAMED is structured around 6 interconnected modules and a public website:
- Actor registration
- UDI/Device registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
What is the state of play of the implementation of EUDAMED?
The 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 declaring the functionality of the first four modules has been published in the OJEU of 27 November 2025.
In accordance with the transitional provisions set out in Regulation (EU) 2024/1860, this publication triggers a transition period of 6 months;
Therefore, as from 28 May 2026 the first four modules are mandatory to use:
- Actor registration (available voluntarily since December 2020)
- UDI/device registration (available voluntarily since October 2021)
- Notified Bodies and Certificates (available voluntarily since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities)
- Market Surveillance.
The two remaining modules; Post-Market surveillance and Vigilance, and Clinical Investigation & Performance Studies are under development and will be released when they are mandatory to use. There will be no time for voluntary use for these two modules before they become mandatory
- EUDAMED Timeline
- Gradual roll out of EUDAMED - Q&A on practical aspects related to the implementation of the gradual roll-out of EUDAMED pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860
Transitional period
Timelines summarising the tansitional periods for the devices and certificates.
- 6 Months transitional period – Regulation devices
- Devices & certificates registration
- Legacy and Regulation devices placed on the market before the mandatory use
- Certificates registration
Functional specifications
Videos
Disclaimer: In the future, when all modules will be released and mandatory to use all functionalities shown in the videos will be available.
