The Unique Device Identification (UDI) System has been introduced under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) which apply respectively as from 26 May 2021 and 26 May 2022.

The UDI-system allows the identification of medical devices, facilitates the appropriate traceability of medical devices, increases the effectiveness of the post-market safety-related activities for devices, improves incident reporting, enhances targeting field safety corrective actions, reduces medical errors and helps the fight against falsified devices.

The European Commission launched a new helpdesk to support economic operators in implementing the obligations and requirements introduced by the new UDI system (UDI assignment, labelling and registration of devices) and provide support as regards the use of the European Medical Devices Nomenclature (EMDN).


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