The new Regulations contain important improvements including a much larger EUDAMED database than the one that currently exists under the Medical Devices Directives (Eudamed2).
EUDAMED will improve transparency and coordination of information regarding medical devices available on the EU market.
The system will be multipurpose. It will function as a registration system, a collaborative system, a notification system and a dissemination system (open to the public) and will be interoperable.
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 development and implementation of EUDAMED is a high priority for the Commission
- The module on Actor registration is available since December 2020
- The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available in September 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities. Afterwards, the remaining modules as well as the mechanism for scrutiny and the CECP will be released when EUDAMED is fully functional.
Eudamed functional specifications version 4.1. These functional specifications are currently under revision and the timing priority is obsolete.
MDR/IVDR UDI and device
EUDAMED UDI device data dictionary. This document clarifies the data that you should provide to EUDAMED for the UDI device registration module.
- Management of Legacy devices in EUDAMED - Updated version (1.2) - February 2021
Machine-to-machine (M2M) data exchange documentation for economic operators
- M2M data exchange services and entity models introduction
- M2M data exchange services definition
- Service entity model XSD
- Service entity model UML diagrams
- xml samples
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.