Do Specialized Medical LLMs Demand a Radically New Approach Under the EU’s Medical Device Regulation?

We examine the arguments made by Onitiu and colleagues concerning the need to adopt a "backward-walking logic" to manage the risks arising from the use of Large Language Models (LLMs) adapted for a medical purpose. We examine what lessons can be learned from existing multi-use technologies and applied to specialized LLMs, notwithstanding their novelty, and explore the appropriate respective roles of device providers and regulators within the ecosystem of technological oversight.