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
Notified bodies and certificates
Clinical investigations and performance studies
Vigilance and post-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 (voluntary module now available )
UDI/device registration (voluntary module now available)
Notified bodies and certificates (voluntary module now available)
Clinical investigations and performance studies (Q4 2022)
Vigilance and post-market surveillance ( Q4 2022)
Market surveillance (Q4 May 2022)
It is envisaged that all of the modules Eudamed and the audit of the system will be completed before Q1 2023.
Actor Registration Module
In line with the MDCG decision referred to above, the Commission deployed the actor registration module on 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 endeavor 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#/
UDI / Device registration module
The UDI / Device registration module were made available on a voluntary basis on the 4th October 2021. Further details this module can be found on the EU Commission website:
The Eudamed UDI / Device registration module can be found at the following location:
Notified Body and Certificate Module
The Notified Body and Certificate module was made available on a voluntary basis on the 4th October 2021. Further details on this module can be found on the EU Commission website:
The Eudamed Notified Body and Certificate module can be found at the following location:
The remaining three modules in the Eudamed system will be rolled out in line with the EU Commission’s EUDAMED development plan. The Commission prepared a document that outlines the interim processes that can to be followed in the absence of a fully functional Eudamed.
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional (MDCG 2021-1).
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 actors 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.