EU UDI Helpdesk
Welcome to the UDI Helpdesk!
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) and 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 two Regulations will become applicable respectively as from 26 May 2021 and 26 May 2022.
This helpdesk aims to provide support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, which include UDI assignment, labelling and registration of devices. This helpdesk will also provide support as regards the use of the European Medical Devices Nomenclature (EMDN), which the European Commission has made available to the manufacturers and other natural or legal persons required by the MDR and IVDR to use it.