References

This website contains numerous [online] references (mostly official guidelines) dotted around on the various pages. They are collected together here for easy reference. This is in addition to the book and chapter references given on the Publications page. Please let me know if any of the links don't work.

Global

IMDRF documents library

Review paper on global approaches to AIaMD regulation (May 2025)

European Union

Text of the EU MDR

MDCG guidelines

Text of the EU AI Act

United Kingdom

Latest news on the new UK Medical Device Regulations

MHRA guidelines on SaMD/AIaMD

United States

The authority of the FDA to regulate medical devices

FDA guidelines on [medical] devices

AI Action Plan (July 2025)

Other jurisdictions: see Latest News.

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This page was last updated: 26 Sept 2025