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.Registrering af UDI/udstyrForordning (EU) 2017/745 om medicinsk udstyr og forordning (EU) 2017/746 om medicinsk udstyr til in vitro-diagnostik indfører en EU-udstyrsidentifikation...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 announcement14. marts 2023The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification systemNews announcement16. december 2022Functional specifications for the European Database on Medical Devices (EUDAMED)News announcement2. august 2022Version 2.8 of Technical documentation - UDI/Devices registrationNews announcement11. april 2022The EUDAMED UDI/Devices module updated technical documentation is availableSe alle 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…
Registrering af UDI/udstyrForordning (EU) 2017/745 om medicinsk udstyr og forordning (EU) 2017/746 om medicinsk udstyr til in vitro-diagnostik indfører en EU-udstyrsidentifikation...
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 announcement14. marts 2023The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification system
News announcement16. december 2022Functional specifications for the European Database on Medical Devices (EUDAMED)
News announcement11. april 2022The EUDAMED UDI/Devices module updated technical documentation is available
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
