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:
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.