Jul 9, 2013

The International Medical Device Regulators Forum (IMDRF), the successor organization to the Global Harmonization Task Force (GHTF), is seeking comment through August 2013 on proposed definitions of standalone medical device software. The IMDRF sees these definitions as a first step toward establishing an international framework for more uniform regulatory approaches to medical software.

Key definitions in the IMDRF proposal include:

  • Standalone medical device software: software intended for use for medical purposes without having to be embedded within a larger device
  • Medical purpose for software: purposes such as diagnosis or monitoring of disease or injury, life support or conception control
  • Software changes: any changes to software for corrective, adaptive or functionality change purposes
  • Standalone medical device software manufacturer: any person or entity designing and/or manufacturing a standalone medical device software with the intention of making the product available for use under that person or entity’s name
  • Intended use/intended purpose: manufacturer’s objective intent in terms of how a product should be used

Although many medical device market regulators do have requirements in place to address standalone medical device software, the IMDRF notes that little coordination currently exists among these approaches. Furthermore, many existing regulations cover software used in conventional devices, but do not adequately address standalone medical device software. 

Stewart Eisenhart


  • Stewart Eisenhart