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.Yksilöllinen laitetunniste (UDI-tunniste) ja laitteiden rekisteröintiLääkinnällisistä laitteista annetulla asetuksella (EU) 2017/745 ja in vitro -diagnostiikkaan tarkoitetuista lääkinnällisistä laitteista annetulla asetuksella (EU) 2017/746 otetaan käyttöön EU:n yksilölliseen laitetunnisteeseen...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 maaliskuu 2023The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification systemNews announcement16 joulukuu 2022Functional specifications for the European Database on Medical Devices (EUDAMED)News announcement2 elokuu 2022Version 2.8 of Technical documentation - UDI/Devices registrationNews announcement11 huhtikuu 2022The EUDAMED UDI/Devices module updated technical documentation is availableKatso kaikki 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…
Yksilöllinen laitetunniste (UDI-tunniste) ja laitteiden rekisteröintiLääkinnällisistä laitteista annetulla asetuksella (EU) 2017/745 ja in vitro -diagnostiikkaan tarkoitetuista lääkinnällisistä laitteista annetulla asetuksella (EU) 2017/746 otetaan käyttöön EU:n yksilölliseen laitetunnisteeseen...
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 maaliskuu 2023The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification system
News announcement16 joulukuu 2022Functional specifications for the European Database on Medical Devices (EUDAMED)
News announcement11 huhtikuu 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
