In response to a government white paper published in 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its strategic approach to artificial intelligence (AI) in healthcare. This initiative includes a pivotal pilot project aimed at identifying and addressing the regulatory challenges associated with standalone AI medical devices (AIaMD). Initially, the MHRA will support 4-6 virtual or real-world projects through simulation, testing a range of regulatory issues for AIaMDs used for direct clinical purposes within the NHS.

The pilot project employs the regulatory sandbox model, a recognized mechanism for tackling novel regulatory challenges across various sectors. The AI Airlock, a world-leading version of this model in healthcare, is designed to facilitate the safe development and deployment of AIaMDs. By following this robust process, manufacturers can meet the necessary requirements to ensure the real-world viability of these devices.

The MHRA’s regulatory AI Airlock leverages evidence-based work from other bodies with similar focuses and involves collaborative efforts with the NHS AI Lab and the Department of Health and Social Care (DHSC). Given that AIaMD products are deployed via NHS infrastructure, the Devolved Nations play a crucial role in regulatory discussions regarding deployment and post-market surveillance.

This partnership between government, regulators, and industry aims to inform future AI Airlock projects and influence both UK and international AIaMD guidance. This includes collaboration with UK Approved Bodies on UKCA marking and with trusted regulatory partners for the international recognition of medical devices.

Dr. Paul Campbell, MHRA Head of Software and AI, emphasized the significance of the initiative: “We are currently seeing a marked increase in innovative AIaMD products entering the UK market that have the potential to revolutionize the healthcare landscape and provide improved ways to address patient and public needs.

"As a regulator, we must balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure we continue to be an enabler for innovation.

"The launch of the AI Airlock will enhance our collective understanding and accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients."

This fact-finding approach is crucial for safeguarding patients as the potential of AI technology is explored. The AI Airlock aims to enhance the relationship between developers, manufacturers, and the MHRA as a regulatory body, potentially bolstering patient engagement and the safe use of AIaMD products.

The MHRA’s regulatory sandbox is expanding in the healthcare technology space, with ongoing investment in innovative solutions positioning the NHS as an industry leader by 2030.