Recently, we hosted an exclusive webinar featuring Dr Vera Roedel (CEO) and Professor Heinz Wiendl (Co-Founder) from Prof.Valmed®. They have achieved the significant milestone of securing the world's first regulatory clearance for a large language model (LLM) as a medical device.

Do AI medical devices need clinical data for CE mark? Many teams building AI that predicts, measures, prioritizes, or triages ask whether prospective clinical data is required under the EU MDR. Dr Ankeet Tanna outlines when clinical investigations are essential, when indirect clinical benefit and non‑clinical evidence can be enough.

From scribes and image analysis to triage, diagnosis, and treatment planning, the technical capability emerging from startups is already there. What’s less clear is a credible plan for how these tools will enter regulated clinical markets - and remain there.