Global group releases software as a medical device framework

Laura Pedulli | | Health Exec | Policy & Regulations

The International Medical Device Regulators Forum's Software as a Medical Device (SaMD) Working Group, which represents a voluntary group of regulators from 10 countries, has released a proposed framework to harmonize international medical device regulations as they relate to SaMD.

The 25-page report sets out to develop a common approach and understanding of SaMD risks and expected controls that promote safety and public health. This document provides an approach to:

  • Create a framework that categorizes types of SaMD based on their risk profiles.
  • Identify controls that assure safety and effectiveness required to address risks associated with different types of SaMD.
  • Identify essential information for describing the SaMD in terms of the medical purpose, context of use and core functionality
  • Characterize types of SaMDs, based on the essential information, similarity in risk profile and hazards associated with SaMD.
  • Identify measures considered appropriate for assuring reasonable safety and effectiveness.

Regulators can utilize this document as a reference when considering their regulatory requirements, according to the report.  

Comments are invited on the framework by May 31. Read the report here.

Laura Pedulli

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