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).

The new EUDAMED database is expected to be available in 2020. EUDAMED content will be partly available to the public.

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.

These documents might still be subject to adjustments and fine-tuning.

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