MHRA Launches AI Airlock to Fast-Track Medical AI Technologies A new pilot programme explores innovative ways to regulate artificial intelligence (AI) -driven medical devices, aiming to fast-track their safe integration into healthcare systems.

The Medicines and Healthcare products Regulatory Agency (MHRA) has selected five cutting-edge AI-powered medical devices for its new AI Airlock pilot scheme. This initiative aims to streamline the regulation of AI-based medical technologies, ensuring quicker and safer access for National Health Service (NHS) patients.

Among the chosen technologies are devices designed to improve diagnostics in cancer, chronic respiratory disease, and radiology. These innovations, which adapt and learn over time, present unique challenges in proving their safety and efficacy.

The AI Airlock functions as a regulatory "sandbox," allowing manufacturers to test evidence collection strategies under MHRA guidance in a controlled virtual environment. The program is expected to inform a more adaptive regulatory framework, accelerating the approval process while maintaining rigorous safety standards.

Entrepreneurs in medical AI stand to benefit from a clearer path to market and opportunities to revolutionise patient care with transformative technologies.

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."

Karin Smyth, Minister of State for Health (Secondary Care)said:

"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."

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."

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.