Five innovative technologies have been selected by the Medicines and Healthcare products Regulatory Agency (MHRA) for the AI Airlock.
The pilot scheme aims to better understand how we can regulate AI-powered medical devices in a way that that enables getting these types of products to the NHS and patients who need them as quickly and safely as possible.
These novel medical devices have the potential to significantly improve the diagnosis and care of patients.
Those selected for the pilot include medical devices for cancer and chronic respiratory disease patients as well as those requiring radiology diagnostic services.
Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, said: “New AI medical devices have the potential to increase the accuracy of healthcare decisions, save time and improve efficiency, leading to better outcomes for the NHS and patients across all healthcare settings.
“But we need to be confident that AI-powered medical devices introduced into the NHS are safe, and stay safe and perform as intended through their lifetime of use.
“By examining the technologies announced today in a safe setting, in partnership with technology specialists, developers and the NHS, we can test and improve the rules for AI-powered medical devices, helping get products like these to the hospitals and patients who need them sooner.”
Before any medical product can reach patients, there must be evidence to show that it is safe and that it works when used for its intended purpose outside of a study setting.
New AI technology makes it challenging to generate this evidence for a number of reasons, including the fact that the medical device changes as it learns.
AI Airlock is a regulatory “sandbox”, a type of study where manufacturers can explore how best to collect evidence that could later be used to support the approval of their product.
This is done under MHRA supervision in a virtual or simulated setting.
Doing so will help the manufacturer and the MHRA better understand the challenges of regulating AI in medical devices, leading to a more bespoke and enabling regulatory framework, a clearer route to market for industry and paving the way for quicker NHS and patient access to potentially transformative AI technologies.
Science Minister, Lord Vallance, said: “AI Airlock is a great example of government working with businesses to enable them to turn ideas into products that improve lives.
“This shows how good regulation can facilitate emerging technologies for the benefit of the UK and our economy.”
Karin Smyth, Minister of State for Health (Secondary Care), added: “As part of our 10 Year Health Plan, we’re shifting NHS care from analogue to digital and this project will help bring the most promising technology to patients.
“AI has the power to revolutionise care by supporting doctors to diagnose diseases, automating time-consuming admin tasks and reducing hospital admissions by predicting future ill health allowing targeted, preventative action.”
Following an industry-wide call for applications earlier this autumn, eligible candidates were required to demonstrate that their AI-powered medical device has the potential to deliver benefits to patients and therefore the NHS, is a novel or innovative application, and can present a regulatory challenge that is ready to be tested in the Airlock pilot programme.
Being selected for AI Airlock does not constitute a regulatory approval.
The findings from the pilot, due to be announced in 2025, will inform future AI Airlock projects and influence future UK AI Medical Device guidance.
For example, the findings are likely to influence how we work with UK Approved Bodies on UKCA marking and improve the framework of support for manufacturers developing these types of products.
The MHRA’s announcement follows a recent report by Lord Darzi that highlights the critical state of the health service in England and the transformational impact that the AI revolution could have on the long-term future of the NHS.
The MHRA’s AI Airlock addresses the Darzi report’s call for regulatory frameworks that enable the development and implementation of innovative AI medical devices to ensure they are safe and perform as intended.
It forms part of the UK regulator’s overhaul of the medical device regulations.
