Unique Device Identification (UDI) requirements have been introduced under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which become applicable from 26 May 2021 and 26 May 2022 respectively.
The UDI system enhances the identification of medical devices and makes it easier to trace them when necessary. It also increases the effectiveness of post-market safety-related activities for devices, improves incident reporting, enhances targeting of field safety corrective actions, reduces medical errors and helps the fight against counterfeit devices.
On 17 May 2021, the European Commission launched a new Helpdesk to support economic operators in implementing the obligations and requirements introduced by the new UDI system.
The helpdesk provides support on UDI assignment, labelling and registration of devices. It also provides support on the use of the European Medical Devices Nomenclature (EMDN), which the European Commission has made available to manufacturers and others required by the MDR and IVDR to use it.