Applications will shortly open for participants to take part in the Medicines and Healthcare products Regulatory Agency's ("MHRA") first ever regulatory sandbox – the "AI Airlock". During a webinar on Tuesday 23 July, representatives from the MHRA discussed what the aims and eligibility criteria of the sandbox are, with this initial pilot phase open to between 4 and 6 participants.
The MHRA is proactively evaluating AI as a medical device ("AIaMD") from three different angles: (a) the MHRA itself as a user of AI, and how it can use AI to improve its own efficiencies; (b) understanding how customers use AI and how the regulator can help them; and (c) as a regulator of AI medical device products. It is the third of these angles which this new regulatory sandbox fits into.
The MHRA acknowledges that AIaMD 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. However, there are of course significant risks and challenges which need to be looked at and addressed, in order to ensure that patient safety remains paramount.
The sandbox is described as a safe space to test innovative activities (in this context, medical device products powered by AI), where the product owners will have direct access to the regulator. The aim is for the AI Airlock sandbox to allow product owners and the MHRA to come together to gain a better understanding of the targeted challenges and regulatory consequences relating to the current medical device regulatory pathway, using real world products and prototypes of innovative AI medical devices.
Process
Participants will report to the AI Airlock supervisory committee, whom itself will be overseen by the AI Airlock Governance Board. The committee will advise on the testing methodology and risk management on a bespoke, product-by-product basis. The MHRA indicated that the expected workflow will be as follows:
- Applications will open on the MHRA website (see here) at the end of the summer / early autumn (exact dates still TBC);
- Applications will be reviewed and sifted before the final set of participants are selected;
- A bespoke testing design and plan, objectives, success measures and risk mitigation plans will be agreed for each participant / product with the supervisory committee;
- Test implementation phase – with regular checkpoint meetings to be held with the committee;
- Each participant will produce a final report on the outcomes, exit plan and future regulatory activities required and lessons learned. This report will be made public.
The MHRA is clear that the sandbox is not a direct route to market. Standard routes to market will still need to be complied with by the participants – though they will have a much clearer understanding of the hurdles and risks which they need to mitigate against having gone through the sandbox testing.
From an IP perspective, the MHRA clarified on the 23 July Webinar that each participant will enter into a binding memorandum of understanding with the MHRA, which will include confidentiality obligations which should provide sufficient comfort to participants in respect of their IP. However, if any applicants have specific areas of concern around protection of IP, this is to be communicated to the MHRA during the application stage, and further discussions can take place if required.
Eligibility Criteria
The pilot phase is looking for AI products that:
- Have the potential to deliver benefits for patients as a medical device;
- Are genuinely innovative;
- Face a current regulatory barrier; and
- Are conceptually or developmentally robust and ready to be trialled.
Successful applicants to the AI Airlock will be required to work collaboratively and transparently with the project team. Afterwards, all parties will produce reports from their perspectives, summarising the achievements and lessons learnt to inform future regulatory policy and guidance.
Comment
The hope is that the sandbox can assist the MHRA (and the wider medical devices sector) to better understand the complexities of AIaMD and the appropriate use cases which can ultimately improve the health and wellbeing of patients. Whilst the AI Airlock is not a direct route to market, it is being described as a unique opportunity for product manufacturers to gain invaluable insight through working directly with the regulator and will go some way to de-risking innovation.
Further information about the AI Airlock regulatory sandbox can be found here.
Brodies have extensive experience advising clients involved in the medical devices sector. Please get in touch with Grant Strachan or Ally Burr if you would like to discuss the AI Airlock or any other life sciences related issues.
Contributors
Partner
Associate
