Medical Devices       
Medical Devices Coordination Group Document   MDCG  2018 -4   
Page 1 of 3 
  
 
 
 
 
MDCG  2018 -4 
Annex: UDI database  
Definitions/Descriptions and formats  
 of the UDI core elements for systems  
 or procedure packs  
               
 October  2018  
 
 
  
 
 
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 Commission 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  2018 -4   
Page 2 of 3 
  
In accordance with Article 29(2) and Annex VI, Part B of the MDR, in the case of 
systems and procedure packs, the system or procedure pack producer shall 
provide to the UDI database the UDI -DI and all of the following information1: 
 
1. quantity per package configuration (meaning the quantity of systems or 
procedure packs in a package, whenever applicable)  
2. the Basic UDI -DI as referred to in Article 29 (MDR) and any additional UDI -
DIs, 
2a. Indication of s pecific medical purpose of the system or procedure pack  
3. the manner in which the system or procedure pack is controlled (expiry date 
or manufacturing date, lot number, serial number),  
5. name and address of the system or procedure pack producer (as indic ated 
on the label),  
6. the SRN of the system or procedure pack producer  
8. The medical device nomenclature code as provided for in Article 26 (MDR)2 
9. risk class (to be intended as the highest risk class of the device components 
of the system or procedure  pack),  
10. if applicable, name or trade name,  
11.A. name or, if applicable, system or procedure pack model associated with 
the BASIC UDI -DI in the statement drawn in accordance with Article 22.1 of 
the MDR  
11.B. reference or catalogue number, or product n umber found on the system 
or procedure pack label or accompanying packaging to identify a system or 
procedure pack  
13. additional product description,  
14. if applicable, storage and/or handling conditions of the system or 
procedure pack (as indicated on th e label or in the instructions for use),  
15. if applicable, additional trade names of the system/procedure pack,  
18. labelled sterile (y/n) (meaning that the system or procedure pack in its 
entirety is labelled as sterile),  
19. need  for sterilisation before use (y/n)  
22. URL for additional information, such as electronic instructions for use 
(optional),  
23. if applicable, critical warnings or contra -indications  
 
                                                            
1 Please note that format and definition of all UDI data elements are  provided at 
https://ec.europa.eu/docsroom/documents/28669   
2 Applicability of this data element to systems and procedure packs is to be determined at the time of 
designation of the future EU nomenclature for medical devices (foreseen end of 2018/beginning 2019).  Medical Devices       
Medical Devices Coordination Group Document   MDCG  2018 -4   
Page 3 of 3 
  
24. status of the system or procedure pack (on the market, no longer placed 
on the market, recalled, field safety corrective action initiated).  
 
Whenever a label is referred to, the label of the entire system/procedure pack shall 
be meant, in accordance with Article 22(5) of Regulation 745/2017.  
 
 
,