Medical Devices - EUDAMED

Overview

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EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.

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:

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 Notified Bodies and Certificates (third module) are available since October 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.

Functional specifications

Eudamed functional specifications version 4.1. These functional specifications are currently under revision and the timing priority is obsolete.

Data exchange

Machine-to-machine (M2M) data exchange documentation for economic operators

Public site

The official web address of the EUDAMED public website is "ec.europa.eu/tools/eudamed".

Disclaimer:
The documentation in this page is subject to changes and updates whenever new information becomes available.