Medical Devices       
Medical Devices Coordination Group Document   MDCG  2018 -5   
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MDCG  2018 -5 
UDI Assignment to Medical Device Software  
  
 
            
 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 regar ded 
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 -5   
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Specific consideration on UDI rules for software  
UDI Assignment to Medical Device Software  
 
- Scope of UDI requirements for software  
In accordance with Annex VI, Part C of the Medical Device Regulation (EU) 2017/745 
(MDR) and the In -Vitro Diagnostic Medical Device Regulation (EU)  2017/746 (IVDR), 
only software which is commercially available on its own as well as software which 
constitutes a device in itself shall be subject to UDI requirements.   
 
- Basic UDI -DI 
In line with the general Guidance on Basic UDI -DI and changes to UDI -DI1, the Basic 
UDI-DI connects software with same intended purpose, risk class and essential 
design and manufacturing characteristics.  
 
- Changes to UDI -DI 
in accordance with Annex VI Part C, Section 6.5 of the MDR and Section 6.2 of the 
IVDR, a new UDI -DI is required whenever there is a modification that changes the 
original performance, the safety of the software or the interpretation of data . Such 
modifications include new or modified algorithms, database structures, operating 
platforms, architecture, user i nterfaces and new channels for interoperability . Such 
changes would be considered “significant.”  
The Guidance on Basic UDI -DI and changes to UDI -DI2, defines standard rules on 
triggers that entail the creation of a new UDI -DI. It lays down that a new UDI —DI 
shall be required whenever there is a change that could lead to misidentification of a 
device and/or ambiguity in its traceability. In particular, a new UDI -DI shall be 
required in the case of any change of the following device related elements: name or 
trade name, device version or model, labelled as single use, packaged sterile, need 
for sterilization before use, quantity of devices provided in a package, critical 
warnings or contra -indications (e.g. containing latex or DEHP3), CMR4/Endocrine 
disruptors , colour, language. Not all those data elements are however applicable to 
software.  
                                                            
1 The Guidance is available at https://ec.europa.eu/docsroom/documents/28667   
2 The Guidance is available at https://ec.europa.eu/docsroom/documents/28667   
3 DEHP stands for Bis(2 -ethylhexyl) phthalate  
4 CMR stands for carcinogenic, mutagenic, or toxic for reproduction  Medical Devices       
Medical Devices Coordination Group Document   MDCG  2018 -5   
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It can therefore be concluded that, in the specific case of software,  
- Any change of the Basic UDI -DI5 
- Any changes which impact the original performance, safety, or the 
interpretation of data6 
- A change to the name or trade name, version or model number, critical 
warnings or contra -indications, user interface language  
would require a new UDI -DI.   
This is to guarantee the traceability and correct identification of the med ical device 
software.  
 
- Minor software revisions  
In accordance with Annex VI, Part C, point 6.5.4 of the MDR and Annex VI, Part C, 
point 6.2.4 of the IVDR, minor software revisions require a new UDI -PI and not a new 
UDI-DI. Minor software revisions are generally associated with bug fixes, usability 
enhancements that are not for safety purposes, security patches or operating 
efficiency. Minor software revisions shall be identified by a defined manufacturer -
specific form of identification.  
- Evaluation of ch anges to software by the manufacturers  
As part of their maintenance and post -market surveillance activities, manufacturers 
should evaluate the possible impact of any changes to the function of software on the 
software’s qualification as medical device soft ware, its classification, its intended 
purpose and essential design and manufacturing characteristics, as that could trigger 
a new Basic UDI -DI.   
Likewise, any changes shall be assessed in defining the need of a new UDI -DI. 
UDI Placement Criteria  
UDI plac ement criteria for software are laid down in Annex VI, Part C, point 6.5.4 of 
the MDR and Annex VI, Part C, point 6.2.4 of the IVDR.  Additional considerations on 
this aspect will be provided in future guidance.  
                                                            
5 This is a general rule. As indicated in the Guidance on Basic UDI -DI and changes to UDI -DI (available at 
https://ec.europa.eu/docsroom/documents/28667 ), "a UDI-DI shall be associated with one an d only one Basic 
UDI-DI”.  
  
6 Annex VI, Part C, point 6.5.2 of the MDR and Annex VI, Part C, point 6 .2.2 of the IVDR