지침,참고문헌 | MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

MDCG 2019-1_budi_rules_ie_en.pdf (214.8K) [28]

In order to ensure, to the maximum possible extent, the quality of the code value entered in Eudamed, the Basic UDI-DI requirements on format should be as close as possible to the ones for the UDI-DI. 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. This algorithm shall be provided by the issuing entities to the Commission and to the manufacturers.