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/priemonių registracijaReglamentu (ES) 2017/745 dėl medicinos priemonių ir Reglamentu (ES) 2017/746 dėl in vitro diagnostikos medicinos priemonių nustatomas ES priemonės identifikatorius...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 m. kovo 14 d.The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification systemNews announcement2022 m. gruodžio 16 d.Functional specifications for the European Database on Medical Devices (EUDAMED)News announcement2022 m. rugpjūčio 2 d.Version 2.8 of Technical documentation - UDI/Devices registrationNews announcement2022 m. balandžio 11 d.The EUDAMED UDI/Devices module updated technical documentation is availableŽiūrėkite visus 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…
UDI/priemonių registracijaReglamentu (ES) 2017/745 dėl medicinos priemonių ir Reglamentu (ES) 2017/746 dėl in vitro diagnostikos medicinos priemonių nustatomas ES priemonės identifikatorius...
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 m. kovo 14 d.The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification system
News announcement2022 m. gruodžio 16 d.Functional specifications for the European Database on Medical Devices (EUDAMED)
News announcement2022 m. rugpjūčio 2 d.Version 2.8 of Technical documentation - UDI/Devices registration
News announcement2022 m. balandžio 11 d.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