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Unique Device Identification System (UDI)

To track medical devices from the manufacturer to the user, the EU has imposed a registration obligation, which is stored in a UDI system. The intention behind this is a faster response capability in the event of anomalies or urgent incidents. Medical devices can be identified easily and unambiguously, the specific location can be determined and illegally circulated products can be traced more easily. The UDI system works by assigning UDI identification numbers to specific organizations, which must then be affixed to the device and its packaging by the medical device manufacturer.  All UDIs are stored in an EU database that specifies the minimum requirements per medical device, and access to it is public. Producers are required to store the basic UDI data such as name, version and classification of the product in the database and keep it up to date.   

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