MDCG (Medical Device Coordination Group) stated in the newly published guiding principles for issuing entities rules that the Basic UDI-DI requirements on format should be as close as possible to the ones for the UDI-DI. This is to ensure the quality of the code value entered in Eudamed.
”In particular, the Basic UDI-DI code value shall have maximum 25 characters, so that it does not differ too significantly from the maximum length of the UDI-DI as established by the issuing entities;
a check digit/character must be part of the Basic UDI-DI, based on an algorithm defined by the issuing entity.
rithm shall be provided by the issuing entities to the Commission and to the manufacturers.”
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