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.Registracija UDI-ja/proizvodaUredbom (EU) 2017/745 o medicinskim proizvodima i Uredbom (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima uvodi se sustav identifikacije proizvoda EU-a...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. ožujka 2023.The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification systemNews announcement16. prosinca 2022.Functional specifications for the European Database on Medical Devices (EUDAMED)News announcement2. kolovoza 2022.Version 2.8 of Technical documentation - UDI/Devices registrationNews announcement11. travnja 2022.The EUDAMED UDI/Devices module updated technical documentation is availablePrikaži sve 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…
Registracija UDI-ja/proizvodaUredbom (EU) 2017/745 o medicinskim proizvodima i Uredbom (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima uvodi se sustav identifikacije proizvoda EU-a...
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. ožujka 2023.The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification system
News announcement16. prosinca 2022.Functional specifications for the European Database on Medical Devices (EUDAMED)
News announcement11. travnja 2022.The 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
