The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new pilot scheme, AI Airlock, to explore how artificial intelligence (AI) can be regulated within medical devices.
This initiative is part of the agency’s ongoing efforts to accelerate access to AI-powered healthcare innovations while ensuring that they meet safety and efficacy standards.
The AI Airlock pilot scheme will test five AI technologies designed to improve diagnosis and treatment for conditions like cancer, chronic respiratory diseases, and radiology. The UK Government said technologies could significantly enhance patient care by providing more accurate and efficient diagnoses and treatments.
Regulatory Challenges of AI in Medical Devices
The UK Government said a major challenge in regulating AI-powered medical devices is that these technologies can evolve as they learn from new data. Traditional regulatory processes, which typically rely on static data, struggle to assess these dynamic systems. The AI Airlock programme addresses this issue by creating a regulatory sandbox where manufacturers can test their AI technologies in simulated or virtual settings. This approach will help both the MHRA and device manufacturers understand the specific regulatory challenges posed by AI, and develop a framework that balances innovation with safety.
MedTech Regulatory Reform Lead and Chief Officer at the MHRA, Laura Squire, 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,” added Squire.
Pilot Projects Underway
Following a recent call for applications, the MHRA has selected five AI technologies for inclusion in the pilot. These technologies include:
- Lenus Stratify® – an AI device that predicts serious outcomes for patients with Chronic Obstructive Pulmonary Disease (COPD), potentially reducing hospital admissions and enhancing patient care.
- Philips AI Radiology Reporting – an AI tool designed to improve the efficiency and accuracy of radiology reports by automating the summarisation of key diagnostic information.
- FAMOS (Federated AI Monitoring Service) – an AI platform that enables hospitals to monitor and address performance issues in real-time, improving the reliability of AI-powered medical devices.
- OncoFlow – an AI solution that helps healthcare providers create personalised treatment plans for cancer patients, potentially reducing waiting times and improving survival rates.
- SmartGuideline – an AI-powered medical device that assists clinicians in making informed decisions by providing easy access to national guidelines.
A Step Toward Faster NHS Access
Although participation in the AI Airlock does not equate to regulatory approval, the findings from the pilot will inform future AI Airlock projects and contribute to the development of UK AI medical device regulations. The results of the pilot, expected in 2025, will help shape the future regulatory landscape, improving pathways to market for AI-powered medical devices and ultimately facilitating faster access to transformative technologies for patients.
This initiative is part of the MHRA’s broader overhaul of medical device regulations, which includes responding to recommendations from Lord Darzi’s recent report on the future of the NHS. The AI Airlock will contribute to the creation of a regulatory framework that encourages innovation while safeguarding patient safety.