AI Airlock Background
Published 23 June 2025
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1. Why we set 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 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 continues to accelerate 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.
2. 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 team, 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.
3. 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 the AI Airlock project, involvement in this project will benefit manufacturers on their regulatory journey. The MHRA also engages 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.
4. Webinar
Watch our webinar in July 2024 for more detail on the pilot programme launch.
Watch our webinar in July 2024 for more detail on the pilot programme launch.