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 actors . 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 the different competent authorities.

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

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, there will be a declaration in the EU Official Journal that the module(s) is/are functional (planned for Q2 2025 for the first modules). Each module will become mandatory to use six months after the declaration of its functionality is published in the Official Journal of the European Union. There are some exceptions, which will be explained here below.
For a better understanding, in the following we will use T0, T1, T2 to describe the dates of the following steps:

As T0 is currently expected to be in Q2 2025 for the first modules, we could expect that T1 will be in Q4 2025 and T2 in Q2 2026.
The actor, UDI/device and notified bodies/certificates modules are already available from 2021. Since then, actors, devices and certificates could be registered on a voluntary basis.

2. Actor module registration

At T1, the following actors must be registered in Eudamed:

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

3. UDI/device module registration

Some definitions of the terms used in the table:

• MDR / IVDR devices: Devices which have undergone a conformity assessment procedure in accordance with art. 52 MDR and art. 48 IVDR.
• Legacy devices: Medical devices and In Vitro Diagnostics devices which in accordance with the MDR and IVDR’s transitional provisions are place on the market after the MDR and IVDR’s dates of application (i.e. 26/05/21 and 26/5/22) if certain conditions are fulfilled.
• Old devices: MDs placed on the market or put into service before 26/05/2021 (under MDD or AIMDD), IVDs placed on the market or put into service before 26/05/2022 (under IVDD).

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

	Registration on a voluntary basis. However the registration must be done when an action has to be performed in the Vigilance module (when it will be available).
	Mandatory registration.
	Registration only when a post-market surveillance or vigilance action (PMSV action)has to be performed in the Vigilance module (when it will be available). These PMSV actions can be the submission of a periodic safety update report or trend report, reporting of a serious incident or field safety corrective action.

4. Module Vigilance

At T1, the obligations and requirements regarding the Eudamed Vigilance module 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

At T1 Notified Bodies have to register any new certificates and the related decisions.

For the devices placed on the market under the MDR / IVDR before T1, Notified Bodies have an additional twelve months (after T1) to register the certificates (latest version if multiple versions exist) and the related decisions.