OverviewEUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746…Actors registrationThe Actor registration is the first of the six EUDAMED modules.UDI/Devices registrationRegulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification…Notified Bodies and CertificatesRegulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified… Latest updatesNews announcement6 Feabhra 2025Coordinated assessment for clinical investigations: a call for expression of interestAm léitheoireachta: 1 nóiméadNews announcement21 Samhain 2024Gradual roll out of EUDAMED - Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 (November 2024)Am léitheoireachta: 1 nóiméadNews announcement10 Iúil 2024Updated Timeline - Current planning for gradual roll out and modules’ functionality viewAm léitheoireachta: 1 nóiméadNews announcement14 Márta 2023The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification systemAm léitheoireachta: 1 nóiméadFéach na HighlightsThe EUDAMED Information Centre is the central point of support for EUDAMED users, presenting action steps and process logic from a wide range of documentationThe UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI systemFactsheet on MDR requirements for Transparency and Public Information DocumentsPublications
OverviewEUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746…
UDI/Devices registrationRegulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification…
Notified Bodies and CertificatesRegulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified…
News announcement6 Feabhra 2025Coordinated assessment for clinical investigations: a call for expression of interestAm léitheoireachta: 1 nóiméad
News announcement21 Samhain 2024Gradual roll out of EUDAMED - Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 (November 2024)Am léitheoireachta: 1 nóiméad
News announcement10 Iúil 2024Updated Timeline - Current planning for gradual roll out and modules’ functionality viewAm léitheoireachta: 1 nóiméad
News announcement14 Márta 2023The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification systemAm léitheoireachta: 1 nóiméad
The EUDAMED Information Centre is the central point of support for EUDAMED users, presenting action steps and process logic from a wide range of documentation
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system
