Overview EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746… Actors registration On 1 December 2020 the European Commission has made available the Actor registration module.It is the first of six EUDAMED modules.EUDAMED… UDI/Devices registration Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification… Notified Bodies and Certificates Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified… Latest updatesNews announcement | 11 április 2022The EUDAMED NBs & Certificates module updated technical documentation is availableNews announcement | 11 április 2022The EUDAMED UDI/Devices module updated technical documentation is availableNews announcement | 15 november 2021EUDAMED Notified Bodies and Certificates module - Relevant documents and informationNews announcement | 8 november 2021EUDAMED UDI/Devices registration module - Relevant documents and informationÖsszes megtekintése 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
News announcement | 11 április 2022The EUDAMED NBs & Certificates module updated technical documentation is available
News announcement | 11 április 2022The EUDAMED UDI/Devices module updated technical documentation is available
News announcement | 15 november 2021EUDAMED Notified Bodies and Certificates module - Relevant documents and information
News announcement | 8 november 2021EUDAMED UDI/Devices registration module - Relevant documents and information
The UDI Helpdesk is live. It helps the economic operators in the implementation of the requirements introduced by the new UDI system
