EUDAMED 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 is integral part of the implementation of the two Medical Devices Regulations.
Disclaimer: Currently only the Actor, the UDI/Device and the Notified Bodies and Certificates modules are available. In the future, when all modules will be released and mandatory to use all functionalities shown in the videos will be available.
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 use of EUDAMED is not yet mandatory nor required.
Some modules are already available and can be used voluntarily. In particular:
- The module on Actor registration is available since December 2020
- The module on UDI/device registration is available since October 2021
- The module on Notified Bodies and Certificates is available since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities.
The remaining modules (Vigilance, Clinical Investigation & Performance Studies and Market Surveillance) are under development and will be released when they are declared functional and become mandatory to use.
In accordance with the transitional provisions set out in Regulation (EU) 2024/1860 amending the medical devices regulations, the mandatory use of each module will start 6 months after it is declared functional following an independent audit, and the publication of a Commission notice to that effect in the Official Journal of the European Union.
Functional specifications
Data exchange
- The documentation is available in the EUDAMED Information Centre
