AI scribes used to take notes are not medical devices, MHRA says

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By Daniel Pye

The Medicines and Healthcare products Regulatory Agency concluded that the tools fall outside its regulatory framework yet stressed that doctors must review all AI-generated summaries.

AI products used solely for transcription and drafting letters are not considered medical devices, the regulatory body said.

The new guidance supports the government’s ambition for the NHS “to become the most AI-enabled health system in the world,” the agency said.

Yet while many in the health tech industry welcomed the MHRA issuing guidelines, there were concerns about certain use cases – most notably, whether summarising patient notes is predominately an administrative task, as the guidelines seem to indicate, or whether it has a more explicit medical purpose.

Ambient voice technology (AVT) products, often referred to as AI scribes, are increasingly used across the NHS to record and summarise conversations between doctors and patients as a way to help reduce administrative burden.

If these products are used solely for transcription, summarising of clinical conversations, drafting letters or suggesting clinical codes for a doctor to review – they are not considered medical devices under the MHRA’s current framework.