Background
The introduction of the Unique Device Identification (UDI) system referred to in Article 27 of Regulation (EU) 2017/745 on medical devices (‘the MDR’) aims to ensure an adequate level of identification and traceability of medical devices. Basic UDI-DIs, UDI-DIs and UDI-PIs shall be assigned (in compliance with the rules of the designated issuing entities) by manufacturers to all devices, other than custom-made devices, prior to their placement on the market. To further strengthen and enhance traceability and recording of UDIs, manufacturers shall register Basic UDI-DIs and UDI-DIs in UDI/Device registration module of the European Database on Medical Devices (Eudamed).
MDCG 2025-7 - Position Paper: Timelines of implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectac
MDCG 2025-7 - Position Paper: Timelines of implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles
health.ec.europa.eu
