UK AI Governance Guide (2026)

Yes — FCA Consumer Duty PS22/9 applies to all consumer outcomes including those generated or influenced by AI. FCA expectations for consumer-facing AI: (1) AI must not produce outcomes that are unfair to consumers (e.g., AI that charges higher prices to certain demographics without justification), (2) AI recommendations must be suitable for the customer's circumstances (COBS suitability — AI cannot remove the suitability obligation), (3) consumers must be able to understand AI decisions (Consumer Duty "consumer understanding" outcome), (4) consumers must be able to challenge AI decisions (right to human review — Consumer Duty "consumer support" outcome). ClickMasters Consumer Duty AI checklist: human oversight mechanism, explainability, bias testing, complaint process.

MHRA SaMD classification applies to software (including AI features) that meets the definition of a medical device under the UK MDR 2002: software intended to be used for a medical purpose (diagnosis, prevention, monitoring, treatment of disease). Context matters: (1) general health app with step counter — not SaMD (wellness, not medical purpose), (2) app that recommends a specific medication dose — SaMD Class IIa or IIb (treatment of disease), (3) AI that screens radiology images for cancer — SaMD Class IIa or IIb (diagnosis). FCA FinTech AI: not SaMD unless it has a medical purpose. NHS administrative AI (appointment booking, waiting list management): not SaMD unless it makes clinical decisions. ClickMasters conducts MHRA SaMD classification assessment for all NHS and MedTech AI features.