Medical Devices       
Medical Devices Coordination Group Document   MDCG  2019 -1   
Page 1 of 2 
  
 
 
 
 
MDCG  201 9-1    
 MDCG guiding principles for issuing entities 
 rules on Basic UDI -DI 
                
 
 
 January 2019  
 
 
  
 
 
 
 
This document has been endorsed by the Medical Device Coordination Group 
(MDCG) established by Article 103 of Regulation (EU) 2017/745.  The MDCG is 
composed of representatives of all Member States and it is chaired by a 
representative of the European Commission.  
The document is not a European Commissio n document and it cannot be regarded 
as reflecting the official position of the European Commission. Any views expressed 
in this document are not legally binding and only the Court of Justice of the European 
Union can give binding interpretations of Union law. 
 Medical Devices       
Medical Devices Coordination Group Document   MDCG  2019 -1   
Page 2 of 2 
  
 
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 sha ll 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 issuin g entity. This algorithm shall be provided by the 
issuing entities to the Commission and to the manufacturers.