UDI for software products

Stand-alone software

Any software that is commercially available and thus represents a stand-alone medical device is subject to UDI requirements. The software version serves as a relevant identification element, which is displayed in the UDI-PI.

A new UDI-DI is required whenever there is a change in the software that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, a new UDI-DI is required whenever the following elements are changed:

  • Name or trade name
  • Version or model of the product
  • Labelling as a disposable product
  • Marking as sterile packed
  • Need for sterilization before use
  • Quantity of products provided in one package
  • Critical warnings or contraindications
  • CMR/Hormones
  • Performance and effectiveness
  • Security
  • Intended Purpose
  • Interpretation of the data

 

Examples of technically significant changes in a software as a medical device are changes in: 

  • Algorithms
  • Structure of the database
  • Operating system
  • Architecture
  • User interface
  • Interoperability

 

A new UDI-PI is assigned in case of minor changes:

  • Bug fixes
  • Security patches
  • User interface (if the changes only affect usability and not security)

 

As a manufacturer one could say that all changes to the third digit of the software version number only lead to a new UDI-PI; all other changes lead to a new UDI-DI.

 

Software as a component of another medical device 

A software that is not commercially available on its own and does not constitute a medical device itself, is not subject to UDI requirements (i.e. software as a component of another (hardware) medical device that is necessary to use the actual medical device). 

 

Medical device software (MDSW) UDI-DI obligation 
Yes No 
  Stand-alone software  X  
  • Stand-alone software with significant changes 
 X  
  • Stand-alone software with minor changes 
   X
  Software as a component     X

 

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