The Royal College of Physicians is uneasy that the MHRA will not classify all automated voice technologies (AVTs) used in healthcare as medical devices.

The Royal College of Physicians (RCP) has expressed concern following the UK government’s announcement that the Medicines and Healthcare products Regulatory Agency (MHRA) will not classify all automated voice technologies (AVTs) used in healthcare as medical devices.

“We are concerned that not including all automated voice technologies in healthcare settings from the medical device framework risks creating gaps in oversight at a time when these tools have the potential to influence decisions about patient care,” said RCP clinical digital health lead Anne Kinderlerer.

“If an AI-generated summary omits clinically relevant information or introduces errors, the consequences can extend far beyond simple notetaking,” she added.

New guidance from the MHRA has clarified that AVTs intended “solely for transcription, summarising clinical conversations, drafting letters or suggesting clinical codes for clinician review” are not regulated as medical devices under the current framework, and that this will not change.

This is a departure from previous NHS guidance, under which suppliers needed to hold MHRA Class I medical device registration to be included on the NHS-approved AVT self-certified supplier registry.

Increasingly used

AVTs are increasingly being used across the NHS to record, transcribe and summarise clinical consultations. However, these tools do not simply provide voice transcription. They use generative AI to identify, interpret and prioritise information, determining what is important enough to include in a summary. In this sense, they function as inference machines, applying automated judgements about relevance, significance and meaning that can influence clinical decision-making.

The RCP has consistently called for smarter regulation that supports innovation and rapid adoption while increasing clinician and patient confidence in these technologies. By not including all AVTs used in healthcare in the medical device regulatory framework, this could weaken oversight of technologies that provide clinical decision support, making it harder to identify and respond to risks.

In addition, where an AVT produces inaccurate documentation, omits relevant information or contributes to patient harm, responsibility will fall more heavily on individual clinicians and trusts, rather than being shared within a regulated device framework.

The new guidance places significant weight on the stated intended purpose of manufacturers when determining whether a product is regulated as a medical device. This could create a scenario where similar technologies may be regulated differently depending on how they are marketed, rather than how they function in clinical practice.