Software’s role in healthcare is becoming increasingly critical, as a diverse array of products serves various medical and administrative functions across clinical and private settings. A subset of software that is used in healthcare is regulated as a medical device globally by regulatory authorities.
In 2013, the International Medical Devices Regulators Forum (IMDRF) introduced the concept of Software as a Medical Device (SaMD) and subsequently proposed a possible risk categorization framework (IMDRF/SaMD WG/N12 FINAL:2014). Building on the collective experience of its members, the IMDRF SaMD Working Group (WG) now has an opportunity to add to those initial concepts by providing guidance related to device characterization and risk characterization, for a broadened scope of medical device software. In the context of this document, risk characterization is meant to help identify potential harms associated with a medical device software and is based on a careful review of device characterization.
Risk characterization can help to develop a robust understanding of the overall risk of the device and can be helpful as an input to risk assessment and management activities or as an input to risk categorization and device classification.
This new document is intended to focus on characterization and can supplement categorization/classification frameworks (e.g., N12 and other legally defined classification schemes across jurisdictions) by providing additional considerations on medical device software and related risk characterization.
Although this document is focused primarily on characterizing risk to serve as an input for categorization, benefits should be considered as part of premarket authorization.
The term “SaMD” has evolved to include a more diverse landscape of software and varied interpretations across jurisdictions. The concepts presented in this document are not exclusive to any specific interpretation of the term SaMD. Rather the concepts can be helpful to consider more broadly for any software that meets the definition of a medical device or is part of a medical device.