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
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- 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.