The Basic UDI-DI is the main access key for device-related information in the Eudamed database and it is referenced in relevant documentation [e.g. certificates (including certificate of free sale), EU declaration of conformity, technical documentation and summary of safety and (clinical) performance)].
It is intended to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics.
It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item. Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner.
MDCG 2018-1 v3 guidance provides additional information on Basic UDI-DI.
The Basic-UDI is the high level grouping for devices with:
- same intended purpose
- same manufacturer
- same attributes
- essential characteristics