Reason about UK MHRA expectations for AI as a Medical Device (AIaMD) and Software as a Medical Device (SaMD): what the AI Airlock regulatory sandbox found about AI-specific risks (synthetic data, hallucination/non-determinism, explainability-vs-performance, model drift, automation bias), and how software/ AI is classified and regulated under the UK Medical Devices Regulations 2002. Use for UK-facing AIaMD/SaMD questions, AI risk-mitigation design (e.g. RAG), or post-market surveillance planning. Guidance only — not legal or regulatory advice.
