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Issuing entities
The issuing entities operate a system for the assignment of UDIs. Following a call for applications launched at the end of 2018, the Commission has designated the following entities:
For more information, please refer to Commission Implementing Decision (EU) 2019/939 of 06 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices.
The MDR does not limit the use of issuing agencies for correct labelling. Therefore the manufacturer can use different issuing agencies for UDI labelling on the different packaging levels. While doing so, the manufacturer can also decide which agency to be used for creating the Basic UDI. The Basic UDI is an identification information for a group of medical devices having the same indented use and same design.
It is also the global access key for EUDAMED, identifying the devices covered by that specific Basic UDI-DI. The EUDAMED links the Basic UDI information to the UDI-DI identified on the first level and the following higher packaging levels, regardless which issuing agency is used by the manufacturer.
According to the latest data dictionary, provided on the websites, the database field FLD-UDI-01 allows the entry of the issuing agency. With the above mentioned, the use of different agencies for UDI and Basic UDI is possible.