The UK’s AI/ML Medical Device Plan

by | Sep 21, 2021 | Compliance, Consulting Group, FDA, ISO, Medical Devices, Quality, Quality Systems, Regulatory, Software


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The FDA has begun tackling AI/ML software as a medical device (SaMD) this year, but there was a noticeable silence on the topic from other international regulatory authorities. Since Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has been given more freedom to establish plans without the burden of incorporating EU MDR policies.

Similar to the FDA’s AI/ML Action Plan that was released earlier this year, the MHRA’s Software and AI as a Medical Device Change Programme aims to provide a regulatory framework for these groundbreaking devices.[1] This guidance walks manufacturers through what the MHRA proposes for every step of the medical device lifecycle, which includes post-market requirements. The MHRA has also instituted various working groups to help develop and drive policies surrounding AI/ML SaMD’s, which they hope to finalize by the summer of 2023.

AI/ML can be a powerful tool in a medical device with the power to better diagnose and treat a broad range of diseases. Additionally, since the software is rooted in the ability to learn and develop itself without the direct influence of human programmers, it is essentially continuously improving. This, as suspected, is a nightmare for regulators though. One of the main quality fundamentals for medical device manufacturers is that change control must be strictly adhered to. There should be no changes to a device, even a SaMD, without thorough analysis, testing, and validation. The aim for the FDA, and now the MHRA, is how to overcome traditional regulatory problems in a very non-traditional device.

Regulations for AI/ML are developing and changing every day, and likely will for quite some time. The various regulatory bodies have been continuously calling on the industry to join the conversation on developing these policies, to ensure there is no undue burden on manufacturers. EMMA International has the expertise to assist with ensuring that your SaMD is compliant, even if it incorporates AI/ML. Call us at 248-987-4497 or email info@emmainternational.com to get connected with our team of experts today!  


[1] MHRA (Sep 2021) Software and AI as a Medical Device Change Programme retrieved on 09/20/2021 from: https://www.gov.uk/government/publications/software-and-ai-as-a-medical-device-change-programme/software-and-ai-as-a-medical-device-change-programme

Madison Wheeler

Madison Wheeler

Manager of Technical Operations - Ms. Wheeler serves as EMMA International’s Manager of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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