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 and developed by the European Commission. 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 improves transparency and coordination of information regarding medical devices available on the EU market.
The system is multipurpose. It is a collaborative and interoperable platform, that will functions as a registration system, a collaborative and a dissemination system (partially open to the public).
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
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. However, their use cannot be imposed. In particular:
- The module on Actor registration is available for voluntary use since December 2020
- The module on UDI/device registration is available for voluntary use since October 2021
- The module on Notified Bodies and Certificates is available for voluntary use 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 the entire EUDAMED system (including all six modules) is declared fully functional.
The mandatory use of the system will start when the entire EUDAMED system (including all 6 modules) has been declared fully functional following an independent audit and a Commission notice to be published in the Official Journal and in accordance with the transitional provisions set out in the medical devices regulations.
Eudamed functional specifications version 4.1. These functional specifications are currently under revision and the timing priority is obsolete.
Machine-to-machine (M2M) data exchange documentation for economic operators
- M2M data exchange services and entity models introduction
- M2M data exchange services definition v2.0
- Service entity model XSD v.2.0.1
- xml samples v2.0
The official web address of the EUDAMED public website is "ec.europa.eu/tools/eudamed".
The documentation in this page is subject to changes and updates whenever new information becomes available.