AI Airlock, CERSIs and a new global AI network for health regulators
Source: gov.uk (2025-06-26)

Med Tech Regs blog, June 2025: A focus on Software and AI.

Marinos Ioannides, Head of Software and AI Medical Devices:

If you’re anything like me, Summer in Britain is a season of transformation and hope. Gone are the frozen, damp morning dog walks in darkness. Coats and jackets are locked away, half-empty half-forgotten tubes of sun cream emerge from deep cupboards, radiators are joyfully turned off.

The same feeling suffuses the Software and AI team here at the MHRA. Our recent AI Airlock webinar and this week’s opening of our new call for applications (https://www.gov.uk/government/news/ai-breakthroughs-drive-expansion-of-airlock-testing-programme-to-support-ai-powered-healthcare-innovation) boldly announces a new year of inspiration, exploration and progress in innovative regulation. Building on the successes of last year’s excellent pilot programme, we’re eager to unlock and expand insights with industry and see first hand how innovative products and teams can help identify regulatory challenges in the Software as Medical Devices space.

The Centres of Excellence for Regulatory Science and Innovation (CERSIs) (https://www.ukri.org/news/developing-regulatory-science-to-advance-healthcare/) are further enhancing MHRA delivery. RADIANT announced their Innovator Support Programme (https://digitalhealth.london/programmes/radiant-cersi), giving companies the opportunity to trial open-source tools, educational materials and workshops to demystify regulations and make sure that regulatory complexity does not stand between patients and life-changing technologies.

For clarity, the two programmes deliver subtly different changes “behind the scenes” here at the MHRA. The direct engagement the MHRA has with members of the AI Airlock allows the findings to inform our foundational thinking for the regulation of Software and AI Medical Devices. The information and detail delivered by RADIANT is downstream of this – augmenting what tools, educational material and guidance is provided to help innovators navigate the broader regulatory landscape.

Not to be outdone, CERSI-AI (https://www.cersi-ai.org/) have also ramped up their productivity, coordinating key meetings between academics, clinicians and the MHRA to unpick the nuances of AI regulation, now and in the future. With a clear path to sustainability and deliverables already being met, both CERSIs continue to improve and inform this rapidly developing space.

This is part of a broader perspective at the MHRA – that innovation and patient safety are not in opposition. Rather, innovation, driven by competition, delivers better products which make patients safer. Demands for patient safety, through clear documentation and proportionate regulation that provides a level playing field and secure, protective framework, create a more transparent market ensuring innovative products excel.

In the spirit of summer, our work alongside Health AI presents a real growth opportunity. This week we were proud to announce that we became the first country in the world to join Health AI’s new global network of health regulators (https://www.gov.uk/government/news/uk-mhra-leads-safe-use-of-ai-in-healthcare-as-first-country-in-new-global-network) focussed on the safe and effective use of AI in healthcare. As a founding pioneer nation, we will work with regulators around the world to share early warnings on safety, monitor how AI tools perform in practice, and shape international standards together – helping make AI in healthcare safer and more effective for patients around the world.

Our work in the Digital Mental Health space continues to bear fruit. As we progress and deliver key, actionable insights through our specific guidance, we continue our engagement with experts to direct and augment our publications. If you’re attending the Royal College of Psychiatrists International Conference in Newport this week, you’ll see MHRA representatives there, eager to hear how we can enhance our work to deliver useful insights in this essential HealthTech space.

Just as no good summer holiday is possible without a translation phrasebook, we will shortly be publishing our Good Machine Learning Practice (GMLP) guidance to ease translation between regulatory frameworks. By transparently outlining our logic, we hope that industry, users and other regulators will be reassured of our alignment with international principles in this emergent space and get insights into our thinking and processes. As we refine this piece of keystone guidance, we also continue to progress our CyberSecurity and AI development and deployment guidance and we look forward to publishing that soon.

Beyond software, the innovative devices team moves from success to success with a clear, tangible deliverable from our accelerated Innovative Devices Access Pathway (IDAP). Revolutionary technologies like HistoSonics’ ultrasound device (https://www.gov.uk/government/news/nhs-red-tape-blitz-delivers-game-changing-new-cancer-treatment), which breaks up tumours without surgery or radiation, is the sort of thing once considered science fiction. Yet, thanks to the excellent work of IDAP partners and MHRA colleagues, patients now have access to a game changing treatment for liver cancer – an example of smart, agile regulation in action.

And, of course, no Summer would be complete without London Tech Week. It’s a genuine pleasure to see the wonders that innovators continue to create. The opportunity to exchange ideas, debate economics and regulations, and get hands-on experiences with new developments is a real privilege. Presenting our regulatory strategy alongside leaders like David Lawson from the Department of Health and Social Care and Richard Phillips from the Association of British HealthTech Industries at Australia House was an opportunity only surpassed by a chance to see the Lord Mayor of the City of London in the flesh - bedecked with full ceremonial chain and garb!

Whether you’re out in a park turning red while trying to get a year’s supply of Vitamin D, or gritting your teeth as your laptop overheats, don’t curse the season of the sun. The MHRA are here learning, innovating and applying international best practices to maximise patient safety today and tomorrow, whatever the weather!