Further clarification concerning the Basic UDI-DI

MDCG today published another guidance explaining more details on the Basic UDI-DI that will be relevant for the

  • EUDAMED Database
  • Manufacturer's Declaration of Conformity
  • And the Technical Documentation


  • MDCG 2019-1
    • MDCG guiding principles for issuing entities rules on Basic UDI-DI 

The core information included is:

  • The Basic UDI-DI code value shall have maximum 25 characters
  • A check digit/character must be part of the Basic UDI-DI


Further guidance concerning the UDI was already published by MDCG in other guidances.