Medical Devices       
Medical Devices Coordination Group Document   MDCG  2018 -6   
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MDCG  2018 -6 
Clarifications of UDI related responsibilities in 
 relation to Article 16 of the Medical Device 
 Regulation (EU) 2017/745 and the  
 In-Vitro Diagnostic Medical Device  
 Regulation (EU) 2017/746  
            
 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 -6   
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Relevant obligations arising from Article 16(1)  
Any distributor, importer or other natural or legal person that assumes the obligations 
incumbent on manufacturers in accordance with Article 16(1), assumes all the 
relevant responsibilities related to UDI, including UDI labelling.  
This means that those e conomic operators must also apply for registration as 
Manufacturers, receive a Single Registration Number (SRN), apply for the 
appropriate conformity assessment procedure and feed and provide UDI -product 
registration.  
However, in accordance with the provis ion of Article 16(1)a, when a distributor or 
importer enters into an agreement with a manufacturer whereby the manufacturer is 
identified as such on the label, the manufacturer is responsible for meeting the 
requirements placed on manufacturers in this Reg ulation, including the relevant UDI 
obligations.  
 
Relevant obligations arising from Article 16(2) to 16(4)  
The distributor or importer carrying out the operations in Article 16(2) shall ensure 
that: 
-  the activities mentioned in points  (a) and  (b) of par agraph  2 are performed by 
means and under conditions that in no way compromise the readability of the UDI 
carrier and its information identifying the actual device.  
- the specific procedures are part of the distributor's or importer’s quality 
management sy stem.