In the UK, Class I SaMD and AIaMD products are self-certified, which means no UK Approved Body (or EU Notified Body), no ISO 13485 certification, and no third-party conformity assessment. In the US, 510(k) exempt devices also have no regulatory scrutiny from the FDA. Find out more about proportionate mini-QMS for these lower risk devices.

ISO 14971 has been central to medical device risk management for over two decades. It provides a structured and defensible methodology: identify hazards, analyse hazardous situations, estimate and evaluate risk, implement controls, and determine whether residual risk is acceptable in light of clinical benefit.

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.