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.
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:
- Actors registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
- EUDAMED public
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 module (Vigilance, Clinical Investigation & Performance Studies and Market Surveillance) are under development and will be released when EUDAMED is declared fully functional.
In accordance with the transitional provisions set out in the medical devices regulations, the mandatory use of the system will start 6 months after the entire EUDAMED system (including all 6 modules) has been declared fully functional following an independent audit, and the publication of a Commission notice in the Official Journal of the European Union.
- Eudamed functional specifications version 7.2