Basic UDI-DI

The Basic UDI-DI does not appear on any label or package. It links the device to certificates, the declaration of conformity, the technical documentation and EUDAMED, so changes that affect it need careful planning.

The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with 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 covered by that Basic UDI-DI in a unique manner.

MDCG 2018-1 Rev.4, The Basic UDI-DI