In our blog post on 22 February 2024 we reported on the Medicines and Healthcare products Regulatory Agency (MHRA) announcement that it intended to launch a regulatory sandbox for software and AI medical devices called the "AI-Airlock". The pilot project went live on 9 May 2024, and government sources are citing it as a key component of the MHRA's strategic approach to AI, published on 30 April 2024 (discussed in a separate post).
What is the AI Airlock?
The aim of the AI Airlock is to identify the regulatory challenges posed by standalone artificial intelligence medical devices (AIaMD). The MHRA has created a platform through which regulators, manufacturers and other relevant stakeholders can bring their expertise and work collaboratively to understand and mitigate novel risks associated with these products. A small number of real-world AIaMD products will be assessed by project participants to identify possible regulatory issues that could arise when AIaMD products are used for direct clinical purposes within the NHS.
The AI Airlock has been set up to follow the regulatory sandbox model. However, it is described as being different from other regulatory sandboxes due to the collaboration between the MHRA, DHSC, NHS AI Lab, NHS England and UK Approved Bodies.
Why is the MHRA launching the AI Airlock?
The MHRA has observed an influx of cutting edge and innovative devices to the UK market. Many of these devices incorporate AIaMD and other digital technologies using AI. While such products have the potential to revolutionise the healthcare landscape by improving the ways in which the needs of patients' and the public are met, their potentially disruptive nature may also pose significant safety risks and novel regulatory challenges.
In line with the government flexible "pro innovation" approach to AI, the MHRA aims to strike the right balance between the level of regulatory oversight required to ensure patient safety and the adaptability required to address particular risks and concerns in a way that does not hamper innovation.
Some of the risks associated with AIaMD, as well as Software as a Medical Device (SaMD) products, are identified and mitigated via existing regulatory frameworks and processes, which are currently subject to ongoing reform. The MHRA refers, in particular, to its existing publications and further planned guidance documents outlined in the Software and AI as a Medical Device Change Programme. However, the pace of innovation in this space means that increased collaboration and more proactive and agile ways of working are needed.
What are the outputs of the project?
- Participants will have access to AI Airlock product reports, with the aim of sharing knowledge and findings to assist with further funding or assessment activities.
- The MHRA intends to engage academic expertise to assess the multi-partner approach to the use of regulatory sandboxes and its impact on the innovation landscape.
The outputs will also inform subsequent phases of the project in the short term, and future MHRA guidance and policy in the longer term. They will also be used to explore any limitations to existing approaches for demonstrating regulatory compliance.
Who are the project partners?
- Team AB: Team AB consolidates the expertise of UK Approved Bodies (equivalent to Notified Bodies in the EU) with a view to increasing the consistency with which UK medical device regulatory requirements are interpreted.
- The NHS: the AI Airlock project will collaborate with the Department of Health and Social Care (DHSC) and the NHS AI Lab, to link the regulatory challenges identified by the project with the realities of the UK healthcare system.
How can you get involved in AI Airlock?
The MHRA will publish a call for applications after the project webinar on 5 June 2024. Once received, applications will be reviewed and four to six will be selected for the pilot project, with the aim of covering a range of regulatory issues across different sections of healthcare or clinical disciplines and different levels of product regulatory maturity.
Each product airlock will be set up to take account of product specific characteristics and innovation needs. This tailored approach is geared towards making the airlocks sufficiently flexible to address any issues that may come up during the project and to maximise opportunities to explore concerns within acceptable risk levels. A product may be removed altogether based on safety concerns. The aim is for the process to be dynamic and for products to be able to move between project categories as their assessment progresses.
Although regulatory conformity is not an objective of the project, the MHRA notes that participants "will benefit manufacturers on their regulatory journey".
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