---
title: "MHRA SaMD & AI: definition | KYE Protocol™ glossary"
description: "MHRA SaMD & AI: UK Medicines and Healthcare products Regulatory Agency Software-as-a-Medical-Device regime."
url: https://kyeprotocol.com/glossary/mhra-samd/
lang: en
source: "KYE Protocol"
---

> MHRA SaMD & AI: UK Medicines and Healthcare products Regulatory Agency Software-as-a-Medical-Device regime.

Framework dictionary

# MHRA SaMD & AI

UK Medicines and Healthcare products Regulatory Agency Software-as-a-Medical-Device regime.

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.

**Source** The KYE Protocol™ glossary, [as published](https://kyeprotocol.com/glossary/#mhra-samd). Not legal advice.