28th August 2025
When does a large language model (LLM) become a medical device?That critical question shaped a series of insightful discussions at our recent expert workshop, part of the Qualification and Risk Classification of LLMs project led by the AI & Digital Health Group at the University of Birmingham.
Funded by The Health Foundation and supported by CERSI-AI, we brought together regulatory experts from the Medicines and Healthcare products Regulatory Agency, notified bodies, and AI verification specialists to explore one of digital health’s most urgent challenges.
Together, we analysed real-world LLM use cases across healthcare, mapped regulatory pathways, and assessed device classifications and risk levels under existing frameworks. The conversations highlighted both the practical hurdles and exciting opportunities facing innovators and regulators alike. A huge thank you to everyone who attended and contributed to the discussions, and to our brilliant team for helping to shape such a thought-provoking and productive day.
This work reflects our commitment to enabling smarter, more adaptive regulation that supports safe and effective innovation in digital health – a commitment we’ll continue advancing through our ongoing collaborative workshops.
