The crosswalk

One device. Seven regulators. One read.

A side-by-side view of how the major regulators are positioning on AI in Software as a Medical Device. Bookmark it · permalink: /crosswalk.

The crosswalk · preview

One device. Seven regulators. One read.

A condensed view of how the major regulators are positioning on AI in SaMD. Use it to scope your global submission strategy before the divergence multiplies your timeline.

FDA

United States · FDA

Leading

PCCP final guidance, AI/ML Action Plan, draft guidance on AI-enabled device software functions.

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European Union · AI Act + MDR

Statutory

AI Act classifies medical AI as high-risk; full obligations apply Aug 2026 alongside MDR.

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MHRA

United Kingdom · MHRA

Advanced

Software & AI as a Medical Device Change Programme, AI Airlock sandbox underway.

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Canada · Health Canada

Advanced

Pre-market guidance for ML-enabled medical devices; aligned with FDA/MHRA principles.

IDATEN + Confirmation of Change Plans expanded to AI/program medical devices (Sept 2025).

Reformed software rules + AI evidence guidance; AI regulation page refreshed Feb 2026.

Technical review guidelines for AI medical devices; algorithm filing required.

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