Eudamed

  1. Introduction
  2. Actor module registration
  3. UDI/device module registration
  4. Module Vigilance
  5. Module notified bodies and certificates

1. Introduction

Eudamed is structured around 6 interconnected modules:

  • Actors: identification of economic operators. These actors will have to identify themselves before placing their medical devices on the market.
  • UDI/Devices: registration of medical devices. Unique Device Identifier (UDI) will also be integrated into this module.
  • Notified bodies and certificates: registration of notified bodies and certificates they issue.
  • Clinical investigations and performance studies: registration of clinical trials and performance evaluations.
  • Vigilance and post-market surveillance : all post-market surveillance and vigilance reports.
  • Market surveillance: coordination of market surveillance activities between competent authorities.

Link to the EUDAMED database

Most of the information in the “Actors”, “UDI/Devices” and “Notified bodies and certificates” modules is accessible to the public. Information in the other modules will have a limited public access (“Clinical Studies”, “Vigilance” and “Market Surveillance”).

The MDR and IVDR regulations have been amended by regulation (EU) 2024/1860 to allow a gradual roll out of Eudamed. When one or more Eudamed modules is developed, additional steps will be carried out such as the verification of the functionality by an independent audit and the consultation with the Medical Device Coordination Group (MDCG).
Once these steps have been successfully completed, an announcement is published in the Official Journal of the EU stating that the module(s) is/are operational. The use of each module will become mandatory six months after publication. The first four modules (Actors, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance) were declared functional on November 27, 2025. This means they must be used mandatorily from May 28, 2026. There are a few exceptions, which will be explained below.
You can also find more information about Eudamed on the European Commission website.
 

2. Actor module registration

On May 28, 2026, the following parties must be registered in Eudamed:

  • Manufacturers
  • Authorized representatives
  • System or procedure pack producer
  • Importer

You can find more information about this actor module via the Questions and Answers page.
 

3. UDI/device module registration

Some definitions of the terms used in the table:

  • MDR / IVDR devices: Devices that have undergone a conformity assessment procedure in accordance with Article 52 of Regulation 2017/745 (MDR) and Article 48 of Regulation 2017/746 (IVDR).
  • Legacy devices: Medical devices and in vitro diagnostic medical devices which, according to the transitional provisions of Regulation 2017/745 (MDR) and Regulation 2017/746 (IVDR), are placed on the market after the application dates of the MDR and IVDR (i.e., 05/26/2021 and 05/26/2022 respectively) if certain conditions are met.
  • Old devices: Medical devices placed on the market or put into service before 05/26/2021 (under MDD or AIMDD) or in vitro diagnostic medical devices placed on the market or put into service before 05/26/2022 (under IVDD).
  • Equivalent devices: Means that the device placed on the market under the regulation and the legacy device have the same identification, such as the UDI-Di, and/or the same catalog/reference number and/or the same trade name, which results from common characteristics.

The actors associated with the device have to be registered in Eudamed before the device registration.  


 

4. Module Vigilance

The vigilance module is still under development. Once this module is declared operational, the obligations and requirements related to it will become applicable.

The following provisions are concerned:

  • Reporting of serious incidents (including periodic summary reports) 
  • Reporting of field safety corrective actions with associated field safety notices
  • Submission of periodic safety update reports and evaluations by the notified bodies for certain devices
  • Reporting of trends
  • Informing the manufacturer that a coordinated evaluation procedure has been started and identifying the coordinating competent authority.
  • The field safety notices will be made publicly available. 

5. Module notified bodies and certificates

From 28 May 2026, notified bodies must register all new certificates and the associated decisions. For devices placed on the market under the MDR/IVDR before 28 May 2026, notified bodies have an additional twelve months after this date to register the certificates (latest version if multiple versions exist) and the associated decisions.

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