The Medicines and Healthcare products Regulatory Agency (MHRA) is updating regulations applying to software and artificial intelligence (AI) as a medical device.
It has developed a work programme to inform the changes, including reforms of how software should be qualified and classified, and to requirements that apply pre- and post-market.
This is aimed ensuring patients are protected and that manufacturers will have clear guidance to interpret requirements and tools to demonstrate their compliance.
The programme document says the work is aimed at providing a high degree of assurance that the devices are safe and function as intended, that the requirements are clear, and that they take friction out of the market.
The programme includes 11 work packages across two workstreams. Eight are within the stream involves reforms across the software as a medical device (SaMD) lifecycle, and three involve considering further challenges that AI can pose towards device regulation.
MHRA is aiming to run both workstreams between now and summer 2023, and will be working with partners including NHSX, the National Institute for Health and Care Excellence, the Multi Agency Advisory Service and the devolved administrations.
It anticipates that much of the reform will come in the form of clarificatory guidance, standards or processes rather than secondary legislation.
Search for innovation
Minister for Innovation Lord Bethell said: “While the UK remains a leading destination for cutting edge healthcare, we are always searching for new and innovative ways we can improve the health and care system for NHS patients.
“Software and artificial intelligence in medical devices offer the potential to transform people’s lives and these updated regulations will make a significant difference in the diagnosis and treatment of a variety of conditions.
“I look forward to seeing the tangible impact these changes will have on improving patient safety and care for years to come.”
MHRA has also launched a consultation on the future regulation of medical devices and received a grant of £194,000 from the Department for Business, Energy and Industrial Strategy’s Regulatory Pioneers Fund to support its work in the field.
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