Internal Market, Industry, Entrepreneurship and SMEs

European database on medical devices (EUDAMED)

European database on medical devices (EUDAMED)

The new regulations on medical devices (MDR) and on in vitro diagnostic medical devices (IVDR) establish a much wider EUDAMED database than the existing one under the current directives (Eudamed2).

Currently, the EC database on medical devices, Eudamed2, is a secure web-based portal. It is a central repository for information on market surveillance exchanged between national competent authorities and the Commission. Its use is restricted to national competent authorities, it is not open for consultation and is not publicly accessible.

However, the new medical devices regulations contain important improvements including a much larger EUDAMED database. The new EUDAMED will be multipurpose. It will function as a registration system, a collaborative system, a notification system, a dissemination system (open to the public), and will be interoperable.

What is the state of play of the implementation of EUDAMED?

  • The Commission is working on the implementation of the new EUDAMED database, which will improve transparency and coordination of information regarding medical devices available on the EU market.
  • It will contain different modules on actors, UDI & devices, notified bodies & certificates, vigilance, clinical investigations and performance studies and market surveillance.
  • The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.
  • The date of application of the MDR remains May 2020.

We update the documents below under 'functional specifications', 'MDR/IVDR UDI and device', and 'data exchange' as new information becomes available. Please check back regularly for the latest versions as they are subject to adjustments and fine-tuning.

Functional specifications

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

Overview of the MDR UDI and device data sets and IVDR UDI and device data sets to provide for their registration in EUDAMED.

EUDAMED UDI device data dictionary. This document clarifies the data that you should provide to EUDAMED for the UDI device registration module.

Data exchange

Data exchange guidelines

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

Public site

The official web address of the EUDAMED public site will be: https://ec.europa.eu/tools/eudamed
The public site will be available when the EUDAMED is in production, not before.