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Medical Devices - EUDAMED - Latest updates (16)
RSSGradual roll out of EUDAMED - Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 (November 2024)
Updated Timeline - Current planning for gradual roll out and modules’ functionality view
The new UDI Helpdesk is live. It helps the economic operators to implement the requirements introduced by the unique device identification system
Functional specifications for the European Database on Medical Devices (EUDAMED)
Version 2.8 of Technical documentation - UDI/Devices registration
The EUDAMED UDI/Devices module updated technical documentation is available
The EUDAMED NBs & Certificates 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.