Theme UDI – MD software
Target audience Manufacturers
Products concerned MD, IVD
Regulatory references MDR (EU) 2017/745

Annex VI Part C

IVDR (EU) 2017/746

Annex VI Part C

Documents mentioned MDCG 2018-1


This guide provides additional information on the application of the UDI rules for software which constitutes a device in itself. In particular, it specifies in which cases a new UDI-DI is required in the event of changes to the software.

The UDI placement criteria will be the subject of a future guide.