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.
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.
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.
EUDAMED UDI device data dictionary. This document clarifies the data that you should provide to EUDAMED for the UDI device registration module.
M2M data exchange services and entity models introduction (v1 29 May 2019)
M2M data exchange services definition (v1 29 May 2019)
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.