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/eszközök regisztrációjaAz orvostechnikai eszközökről szóló (EU) 2017/745 rendelet és az in vitro diagnosztikai orvostechnikai eszközökről szóló (EU) 2017/746 rendelet uniós eszközazonosító rendszert hoz létre...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 announcement2023. március 14.The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification systemNews announcement2022. december 16.Functional specifications for the European Database on Medical Devices (EUDAMED)News announcement2022. augusztus 2.Version 2.8 of Technical documentation - UDI/Devices registrationNews announcement2022. április 11.The EUDAMED UDI/Devices module updated technical documentation is availableÖsszes megtekintése 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/eszközök regisztrációjaAz orvostechnikai eszközökről szóló (EU) 2017/745 rendelet és az in vitro diagnosztikai orvostechnikai eszközökről szóló (EU) 2017/746 rendelet uniós eszközazonosító rendszert hoz létre...
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 announcement2023. március 14.The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification system
News announcement2022. december 16.Functional specifications for the European Database on Medical Devices (EUDAMED)
News announcement2022. április 11.The 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
