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.Registrácia unikátnej identifikácie pomôcok (UDI)Nariadením (EÚ) 2017/745 o zdravotníckych pomôckach a nariadením (EÚ) 2017/746 o diagnostických zdravotníckych pomôckach in vitro sa zavádza identifikácia pomôcok EÚ...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. marca 2023The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification systemNews announcement16. decembra 2022Functional specifications for the European Database on Medical Devices (EUDAMED)News announcement2. augusta 2022Version 2.8 of Technical documentation - UDI/Devices registrationNews announcement11. apríla 2022The EUDAMED UDI/Devices module updated technical documentation is availableZobraziť všetky 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…
Registrácia unikátnej identifikácie pomôcok (UDI)Nariadením (EÚ) 2017/745 o zdravotníckych pomôckach a nariadením (EÚ) 2017/746 o diagnostických zdravotníckych pomôckach in vitro sa zavádza identifikácia pomôcok EÚ...
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. marca 2023The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification system
News announcement16. decembra 2022Functional specifications for the European Database on Medical Devices (EUDAMED)
News announcement11. apríla 2022The EUDAMED UDI/Devices module updated technical documentation is available
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system
