Module 17 2024

05/12/2024

Chapter 10: Software as a Medical Device

Classification: risk categorization The regulations will amend the classification rules to include the IMDRF SaMD classification rules (I, II, III, IV) for general medical devices (not IVDs) with supporting definitions and implementing rules, adding classification implementation rules and definitions of the following terms: a) critical b) serious c) non-serious d) treat or diagnose e) drive clinical management, and f) inform clinical management. The MHRA wants to ensure the scrutiny applied to SaMD is more commensurate with their level of risk and therefore better protect public health. A move to follow this IMDRF categorization framework is considered a logical, clear, proportionate method for SaMD classification which allows for international alignment.

The Organisation for Professionals in Regulatory Affairs

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Chapter 10: Software as a Medical Device

Therefore, the regulations will adopt the risk categorization in the IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations for classifying SaMDs as general medical devices, with consequential implementing rules and definitions and clear guidance. Classification: airlock classification rule Introducing an ‘airlock classification rule’ is a provision that would allow for a temporary classification to be applied to some SaMDs (which is likely to involve monitoring and restricting the SaMD as if it were a high-risk device) where the risk profile is unclear. This could allow early access to the market for novel and innovative SaMDs while ensuring the safety of users and patients until the risks of the device are properly understood.

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