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UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device

Last Friday (03 May 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Software and Artificial Intelligence (AI) as a Medical Device" that outlines the Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).

This guidance is crucial for ensuring the safety, effectiveness, and quality of these innovative technologies. The scope of the guidance and the types of software and AI covered, including standalone software, mobile applications, and AI algorithms.

Software as a Medical Device (SaMD): Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

Artificial Intelligence (AI): The simulation of human intelligence processes by machines, including learning, reasoning, and self-correction.

Software Group is responsible for taking all reasonable steps to assure the safety of SaMD and ensure the UK public have access to technology that meets a clinical need. The group works across the MHRA to achieve this aim for SaMD and AIaMD through:

  • assisting with pre-market and post-market enquiries from manufacturers

  • conducting technical file reviews and post-market surveillance activities

  • reviewing of technical and clinical aspects of clinical investigations and exceptional use authorisations

  • ensuring medical device regulation is fit for purpose, meets the needs of software as well as AI, and is supported by robust guidance

  • engaging with stakeholders including industry, healthcare organisations and professionals, as well as patients and public to support the functions noted above.

MHRA has unveiled a comprehensive change program and roadmap aimed at implementing regulatory reforms, particularly concerning software as a medical device (SaMD). These reforms cover various stages of the SaMD lifecycle, from qualification and classification to pre-market and post-market requirements.

The program also addresses the challenges and opportunities presented by AI as a medical device (AIaMD), ensuring these devices are well-supported by evidence. It further tackles issues of AI transparency, including explainability and interpretability, as well as adaptivity, such as retraining AI models.

By following this guidance, manufacturers can ensure compliance with MHRA regulations and standards, thereby ensuring the safety, effectiveness, and quality of software and AI used in healthcare.


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