MHRA SaMD & AI

UK Medicines and Healthcare products Regulatory Agency Software-as-a-Medical-Device regime. KYE™ binding: per-decision risk-tier evidence + Annex IV equivalent documentation bound to KYE™ artefacts.

KYE™ Minute explains this term in an episode dated 9 April 2027, once podcast audio is switched on.

SourceThe KYE Protocol™ glossary, as published. Not legal advice.