Eudamed

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 diagnostic medical devices.

Eudamed will include 6 interconnected modules:

  • Actor registration, including SRN

  • UDI/device registration

  • Notified bodies and certificates

  • Clinical investigations and performance studies

  • Vigilance and post-market surveillance

  • Market surveillance

On 30 October 2019, the Commission published a notice where they outlined that the full functionality of Eudamed required the availability and full operation of all six modules in accordance with the technical specifications and confirmed by an audit as referred to in Article 34.  The notice foresaw the launch of a fully functional Eudamed in May 2022. However, at its meeting of 12 March 2020, the MDCG agreed that the Commission will make the different modules of Eudamed available on a gradual basis as soon as they are functional.

Timeline for the availability of the different Modules of Eudamed

  • Actor registration (December 2020)

  • UDI/device registration (September 2021)

  • Notified bodies and certificates (September 2021)

  • Clinical investigations and performance studies (May 2022)

  • Vigilance and post-market surveillance (May 2022)

  • Market surveillance (May 2022)

It is envisaged that all of the modules Eudamed and the audit of the system will be completed before May 2022.

Actor Registration Module

In line with the MDCG decision referred to above, the Commission has confirmed its readiness to deploy the actor registration module as of the 1 December 2020.  Actors that register on Eudamed will be able to obtain a SRN. Further details regarding the actor registration module can be found on the EU Commission website.  

Each economic operator will require validation by their national competent authority.  The HPRA will endeavour to review all economic operators on Eudamed within two working days.

The Eudamed actor module can be found at the following location:https://webgate.ec.europa.eu/eudamed/landing-page#/

Interim Procedures for Modules that are not available by May 2021

As some of the modules of the Eudamed system will not be ready for the date of application of the MDR in May 2021, the Commission is currently preparing a document that will outline the interim processes that will need to be followed in the absence of Eudamed.

Preparing Your Organisation's Systems for Eudamed

Eudamed will provide actors with a user interface where they will be able to access the different modules as they become available. A user interface will facilitate the manual input data using a keyboard and also for some information, e.g. manufacturer incident reports the system will facilitate machine to machine uploads. It is therefore very important for actors to keep a close eye on the European Commission website to obtain the relevant details as they become available. This will ensure that actor can prepare their own local systems to ensure that they are compatible with Eudamed. In advance of each module going live, the Commission website will be updated with the relevant technical specifications and documentation to assist with this process.

Commission Guidance:

  • Draft paper outlining how processes can be managed in the absence of Eudamed. Stakeholder consultation is required.

  • Guidance on Actor Registration & SRNs (published 18th August)

  • Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional (MDCG 2021-1).