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27th September 2021

UK looking to amend AI & software-enabled medical device regulations

The MHRA is working to update the national software and AI rules as a medical device, as part of its new freedoms in Brexit, without any obligation for adopting the EU Member States’ regulatory methods

“These measures demonstrate the U.K.’s commitment, following our exit from the European Union, to drive innovation in healthcare and improve patient outcomes,” states MHRA’s announcement. “Regulatory measures will be updated to further protect patient safety and take account of these technological advances.”
AI and SaMD technologies have the potential to diagnose and treat a wide range of diseases more effectively, but the FDA still has to develop a regulatory framework for machine learning-based software as a medical device. The agency is looking to complete a regulatory framework for adaptive and continuous education algorithms based on the product lifecycle.
Thompson points out that MHRA is “basically a small step earlier” than the FDA’s AI/ML-based SaMD action plan issued in January, which calls for further developing a proposed regulatory framework by issuing draft guidance.
“It’s a step earlier because it’s broader — it covers a wide variety of regulatory issues for all software as a medical device, not just AI,” according to Thompson. “But overall, both governments are trying to do the same thing: outline a path forward for modernizing medical device regulation to address the unique aspects of AI.”
Policy on the various elements mentioned in the MHRA’s SOftware and AI as a Medical Device Change Programme is being worked on by a number of groups within the MHRA.
“The U.K. has said that its work products in each of the different streams will trickle out between fall of 2021 and summer of 2023. It doesn’t appear that FDA is frankly moving any faster,” Thompson said. “The U.K. envisions releasing intermediate documents of course. They will be releasing more detailed timelines of key deliverables and opportunities for public input.”
The MHRA requested members of the public to comment on proposed reforms to the whole medical device regulatory system in the UK, not only AI and SaMD, with the objective of establishing a “world-leading future regime”, prioritising patient safety while promoting innovation.
U.S. authorities published their action plan in January, in the middle of demands for regulatory clarification from AdvaMed and other organisations, on the basis of stakeholder comments on the April 2019 discussion paper on a potential regulative framework for AI / ML-based SaMD.
Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, told the Food & Drug Law Institute conference in May the agency’s January action plan for establishing a regulatory approach to SaMD puts it on schedule for proposed guidance for an AI/ML framework in 2021.
Thompson said that the FDA was planning this year to issue a draught paper, but he claimed that there was no indication of when. The next stage is the public virtual AI-ML transparency workshop, slated for 14th October, which was organised by the FDA in the January action plan, according to Thompson.

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