| Theme | Basic UDI and UDI-DI |
| Target audience | Manufacturers |
| Products concerned | MD, IVD |
| Regulatory references | MDR (EU) 2017/745
Chapter III Annex VI IVDR (EU) 2017/746 Chapter III Annex VI |
| Documents mentioned | UDIWG 2018-1
European Commission : Q/A about UDI |
The purpose of this document is to clarify the concept of a basic UDI-DI and its relationship to certificates and declarations of conformity.
In addition, this guide specifies when a new UDI-DI is required in the event of changes to the system, together with examples.