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

Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software and Artificial Intelligence (AI) as a Medical Device" that provides detailed information for manufacturers, healthcare organisations and professionals, researchers, and patients & public on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD).

The MHRA is responsible for ensuring the quality, safety, and efficacy of medicines, medical devices, and innovative healthcare technologies. As AI applications in healthcare continue to expand, the MHRA has been proactive in providing guidance on the regulation of AI as a medical device.


The recent update by the MHRA is the addition of the FDA and Health Canada's 5 guiding principles for the use of PCCPs to the AI section.


Software Group is responsible for taking all reasonable steps to assure the safety of SaMD and ensure the UK public has access to technology that meets a clinical need. A program and road map to drive regulatory changes are being announced by the MHRA, including key reforms across the software as a medical device lifecycle, from qualification to classification to post-market requirements.


The MHRA with the U.S. Food and Drug Administration (FDA) and Health Canada have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). The MHRA, FDA, and Health Canada have also jointly identified 5 guiding principles for the use of Predetermined Change Control Plans (PCCPs). These principles will help to ensure that our future guidance on PCCPs aligns internationally with these jurisdictions.


Click this LINK to learn more about the Programme Roadmap, Regulatory Framework for Software as a Medical Device, etc.





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