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ViewAttendees 9

Digital Health

MHRA AI Airlock, CERSI AI and RADIANT CERSI: Regulatory Innovation for AI Medical Devices

Thursday, May 7, 2026
10:45 - 11:45 WEST
Location: Auditorium 2
Learning Level: Intermediate
Description: As artificial intelligence transforms healthcare, the UK is leading the charge in reimagining how regulation can keep pace with innovation. This panel explores three pioneering initiatives shaping the future of AI as a medical device (AIaMD): the MHRA’s AI Airlock, the University of Birmingham’s CERSI-AI, and Brunel University’s RADIANT CER

🔹 MHRA AI Airlock Launched in 2024, the AI Airlock is the UK’s first regulatory sandbox for AIaMD. It provides a safe, collaborative environment for testing real-world AI medical products against regulatory challenges, enabling developers, regulators, and NHS partners to co-create solutions that inform future guidance and policy.

🔹 CERSI-AI (University of Birmingham) is the UK’s Centre of Excellence for Regulatory Science in AI and Digital Health. Led by Professor Alastair Denniston and working with our partners, we unite academia, industry, regulators, patients, and the NHS to accelerate safe, trusted innovation. Through research, collaboration, and practical tools, we help health technologies reach patients faster, equitably, and sustainably, positioning the UK as a global leader in responsible AI health innovation.

🔹 RADIANT CERSI (Brunel University of London) RADIANT is a cross-sector consortium tackling regulatory complexity for transformative digital health and AI. Led by Dr Gabriella Spinelli, RADIANT CERSI brings together academia (Brunel, UCL, KCL), NHS (Imperial College Healthcare NHS Trust) and industrial partners (BMJ, Helix data Innovation and Zinc), supporting innovators through evidence-based frameworks and implementation science. Its Innovator Support Programme helps startups navigate regulatory pathways for SaMD and AIaMD, ensuring safe and inclusive adoption.
This session offers a rare opportunity to hear directly from the architects of the UK’s regulatory transformation. Attendees will gain insights into:

• How regulatory sandboxes like AI Airlock are reshaping guidance

• The role of academic-led CERSIs in bridging science and policy
• Methods of practical support available for innovators navigating AI medical device regulation

Learning Objectives:

  • Upon completion, participants will understand the role of regulatory sandboxes in AI medical device development, know how MHRA’s AI Airlock provides a controlled environment for testing AIaMD regulatory framework with industry and understand how sandbox pilots inform future regulatory frameworks and guidance.
  • Upon completion, participants will gain insight into academic-led regulatory science initiatives, discover how CERSI-AI (University of Birmingham) and RADIANT CERSI (Brunel University of London) are shaping evidence-based, inclusive regulatory pathways.and understand the role of academic institutions in bridging innovation and policy.
  • Upon completion, participants will be able to navigate the UK’s evolving AIaMD regulatory landscape, identify key regulatory challenges and opportunities for AI in healthcare, and understand how UK regulators are adapting to the unique risks and benefits of AI technologies.