Last month, the International Medical Device Regulators Forum (IMDRF) reached a consensus on a potentially key aspect of the future regulation of medical software in the US, the EU, Brazil, Canada and Japan, that is, a harmonized definition of when stand-alone software will be considered to be a medical device.

This category of software, dubbed “Software as a Medical Device” (SaMD), includes PC, cloud or mobile applications (apps) that are intended to be used for a specific medical purpose, for example, to assist healthcare professionals in making a diagnosis.  SaMD is distinct from embedded medical software, such as the software that runs MRI control panels, which the IMDRF refers to as “software in a medical device.”

The IMDRF is a taskforce composed of US, EU, Brazilian, Canadian and Japanese regulators.  It was launched in 2013 as the successor to the Global Harmonization Task Force (GHTF).  The abandonment of the GHTF was motivated in part by a desire to relegate industry participants to mere observer status; only regulators have voting rights within the IMDRF.
Continue Reading International Consensus on “Software as Medical Device” Definition