AI Airlock: the regulatory sandbox for AIaMD
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
About the AI Airlock
The MHRA AI Airlock was launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products. The project will enhance our understanding and accelerate solutions to novel regulatory challenges for AIaMD.
Using real-world products, the AI Airlock will bring together expertise from within the MHRA and key partners including the UK Approved Bodies, the NHS and other regulators. The outputs will inform subsequent AI Airlock phases in the short term, and future MHRA guidance and policy in the longer term, while exploring any limitations of existing approaches to demonstrating regulatory compliance.
This webpage contains information about the project, the key partners, pilot cohort candidates and some examples of potential issues we expect to address in the project. You can also find a recording of our public webinar held in July.
AI Airlock pilot cohort
The application window for the 2024 pilot cohort is now closed and applications have been sifted and prioritised against the eligibility criteria. Five candidates have been selected for the pilot project and each will address and specific regulatory challenge as part of the pilot. Read more about the pilot cohort.
The pilot project will run until April 2025 and initially focus on a small number of products, across a range of medical device regulatory issues, within different sections of healthcare or clinical disciplines and levels of product regulatory maturity.
Why we are setting up AI Airlock
As the medical device regulator for UK health and social care, the Medicines and Healthcare products Regulatory Agency (MHRA) holds a central role in patient safety. We are currently reforming the medical device regulations and supporting regulatory guidance, including for Software as a Medical Device (SaMD) which includes Artificial Intelligence as a Medical Device (AIaMD) products. These reforms build on a well-established regulatory system of legislation, guidance and standards to address known challenges and align with other regulatory jurisdictions around the world.
Along with this regulatory system update, we have seen a marked increase in innovative devices entering the UK market, particularly AIaMD and digital technologies using AI, which may be on the borderline of the scope of medical device regulations. Such products have the potential to revolutionise the healthcare landscape, maintain the UK as a home of cutting-edge research and provide improved ways to address patient and public needs. This potential brings novel challenges, shifts in known risks and safety concerns. The MHRA is seeking to balance appropriate oversight to protect patient safety with the agility needed to respond to the particular challenges presented by these products to ensure regulation does not present undue barriers to innovation.
Many of the known risks of SaMD/AIaMD products are identified and mitigated through existing regulatory requirements and processes such as Clinical Investigations and Post Market Surveillance. Our existing publications and further planned guidance documents outlined in the Software and AI as a Medical Device Change Programme provide further assistance to manufacturers. The pace of innovation is accelerating and the balance of rules-based versus principles-based regulation of AI is an ongoing topic across all sectors of society and around the world. To regulate AIaMD effectively and efficiently, increased collaboration and more proactive and agile ways of working are required, to help us find solutions to many unanswered questions.
Collaborating with partners
Team AB: launched in February 2024, Team AB brings together expertise from Approved Bodies to increase consistency of interpretation of UK medical device regulatory requirements. We are delighted to collaborate with Team AB on the AI Airlock project to uncover and navigate medical device regulatory challenges for AIaMD. We will use our collective regulatory knowledge to inform and standardise policy positions in this rapidly evolving area.
The NHS: the AI Airlock project will work closely with the Department of Health and Social Care (DHSC), and the NHS AI Lab, to provide connections and expertise with our healthcare system. Many AIaMD products are deployed via NHS infrastructure making NHS England and the health services in the devolved nations crucial to regulatory discussions such as deployment and post market surveillance.
Project outputs
The objective of AI Airlock is to identify regulatory challenges to AIaMD and work collaboratively to understand and potentially mitigate any risks that are uncovered. Relevant stakeholders and the product providers will be able to use the AI Airlock product reports to share knowledge and findings to assist with further funding or assessment activities. Whilst guarantee of regulatory conformity is not the objective of this project, involvement in this project will benefit manufacturers on their regulatory journey. The MHRA also intends to engage academic expertise to assess the multi-partner approach to the use of regulatory sandboxes and its impact on the innovation landscape. Finally, extension and additional funding, potential changes to medical device regulations and additional guidance documents will be considered for further sandboxes looking beyond AIaMD.
Further information:
If you would like to reach out or ask any further questions you can email the team at [email protected].
Project newsletters and press releases
Policy
Ai Airlock Applications
We are currently closed for new applications to AI Airlock.
Updates to this page
Published 9 May 2024Last updated 4 December 2024 + show all updates
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Press Release added 'MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach'.
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Updated to include information about the five technologies selected for the AI Airlock pilot.
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Added AI Airlock application documents to collection
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Link to July webinar video added.
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First published.