Device qualification and classification of ambient voice technology-enabled products that are medical devices intended to be placed on the market, or put into service, in Great Britain.
This guidance is intended to provide clarity on the qualification and classification of ambient voice technology-enabled products (AVT products) that are medical devices intended to be placed on the market or put into service in Great Britain (GB is England, Wales, and Scotland).
Excerpt from the official page. The original is authoritative.