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 Commission, in agreement with the Medical Device Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are functional
- The module on Actor registration will be the first module made available. Deployment of the module takes place at the latest by March 2021
- The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021. Afterwards, the remaining modules will be displayed as soon as they are functional
The Eudamed functional specifications (v4.1) have been public since 7 February 2019. These functional specifications might be subject to possible changes as some issues are still under discussion.
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.
Machine-to-machine (M2M) data exchange documentation for economic operators
- M2M data exchange services and entity models introduction (v1 29 May 2019)
- M2M data exchange services definition (v1 29 May 2019)
- Service entity model XSD
- Service entity model UML diagrams
- xml samples
The official web address of the EUDAMED public website will be "ec.europa.eu/tools/eudamed".
It will be available once it’s in production and not before.
The documentation in this page is subject to adjustments and fine-tuning. It will be updated as new information becomes available.