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 registrationOn 1 December 2020 the European Commission has made available the Actor registration module.It is the first of six EUDAMED modules.EUDAMED…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 announcement2 August 2022Version 2.8 of Technical documentation - UDI/Devices registrationNews announcement11 April 2022The EUDAMED UDI/Devices module updated technical documentation is availableNews announcement11 April 2022The EUDAMED NBs & Certificates module updated technical documentation is availableNews announcement15 November 2021EUDAMED Notified Bodies and Certificates module - Relevant documents and informationSee all HighlightsThe 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…
Actors registrationOn 1 December 2020 the European Commission has made available the Actor registration module.It is the first of six EUDAMED modules.EUDAMED…
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 announcement11 April 2022The EUDAMED UDI/Devices module updated technical documentation is available
News announcement11 April 2022The EUDAMED NBs & Certificates module updated technical documentation is available
News announcement15 November 2021EUDAMED Notified Bodies and Certificates module - Relevant documents and information
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system
