| 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.