AVT: New guidance arrives as HSSIB launches investigation

Last year, we considered NHS England's growing focus on AI scribes and the question that quickly became central to market access: when does an AI-enabled documentation tool become a regulated medical device? Since then, both NHS England and the MHRA have issued revised guidance, bringing welcome clarification to this important borderline issue.

What are ambient scribing products?

Ambient scribing products are tools that use speech recognition, generative AI and large language models (LLMs) to capture clinical conversations and automatically generate documentation with minimal user intervention. Functions may include:

•    Recording and transcribing consultations;
•    Producing structured clinical notes and summaries;
•    Drafting referral and patient letters;
•    Generating clinical coding suggestions;
•    Populating electronic patient records (EPRs); and
•    Identifying follow-up actions and workflow tasks.

These products can provide significant advantages for clinicians, particularly by reducing administrative burden. Organisations may also benefit from improved quality and consistency of clinical documentation, more complete and timely patient records, enhanced data quality within EPR systems, greater operational efficiency and potential cost savings.

New MHRA guidance

The MHRA’s new guidance on ambient voice technology (AVT) products, provides much-needed clarity on when AI-enabled ambient scribing and documentation tools are regulated as medical devices in Great Britain. (In Northern Ireland, the EU medical devices framework applies.) This document focuses on products that capture and process clinical conversations to produce outputs such as transcripts, consultation summaries, discharge letters and clinical correspondence. 
A key message is that whether an AVT product is a medical device depends on its intended purpose, rather than the technology it uses.

The MHRA recognises that manufacturers may market products for a range of intended purposes. Products that are limited to administrative functions, such as transcribing consultations, generating summaries, formatting information or suggesting clinical codes based solely on explicitly stated information, will generally not be categorised as medical devices.

In contrast, where an AVT product is intended by the manufacturer to support diagnosis, treatment, monitoring or other clinical decision-making functions, it is likely to qualify as a medical device and must comply with the regulatory framework. The guidance also makes clear that intended and actual functionality must be assessed in the context of the wider clinical workflow. The MHRA emphasises that manufacturers cannot avoid regulation through disclaimers if medical claims are made elsewhere in product design, labelling or marketing materials.

While this borderline area can be difficult to navigate, the detailed discussion with examples helps suppliers and manufacturers to think through the positioning of their products. It is also worth noting that the guidance is not a change in approach by the MHRA, it is merely a clarification of how it applies the existing regulatory framework to AVT and is similar to previous exercises around borderline product guidance.

The particular risks associated with generative AI are highlighted, including hallucinations and foreseeable misuse: manufacturers are expected to address these risks through product design and risk management. As AVT products evolve and acquire new functionality, manufacturers should reassess whether changes in intended purpose trigger medical device regulation.

The practical takeaway is that intended purpose remains central: manufacturers need to understand not only what their product does, but how it is presented, configured and used in a clinical setting.

Revised NHS England guidance

In parallel, the NHS England guidance has been updated to align with this clarification (see Version 3 of the Guidance on the use of AI-enabled ambient scribing products in health and care settings). This alignment is important because NHS adoption decisions need to reflect the regulatory analysis used to assess medical device status.

The revised regulatory sections align more closely with recent MHRA guidance on software and AI-enabled medical devices. There is a stronger emphasis on:

• intended purpose;
• medical device qualification;
• ongoing post-market surveillance;
• incident reporting;
• reassessment when product functionality changes; and
• manufacturers' responsibilities following deployment.

For manufacturers, the updated guidance underlines the importance of being clear about intended purpose, product claims and post-deployment responsibilities. For NHS organisations, it provides a more structured framework for assessing whether AVT products can be adopted safely and compliantly.

The NHS England Ambient Voice Technology (AVT) Supplier Registry remains in place and is intended to support NHS providers in identifying and adopting AVT products in a more consistent way. Manufacturers may wish to continue to seek inclusion in this list as it will help evidence compliance with relevant requirements.

HSSIB investigation

Meanwhile, the Health Services Safety Investigations Body (“HSSIB”) announced on 6 August 2026 that it was launching an investigation into the use of AVT in hospitals on the basis that the potential patient safety implications of AVT use in hospitals are not fully understood.

They expect to publish a report in the summer of 2027 with the focus of the investigation being in acute adult secondary care on the following questions:

• how AVT has contributed, or may contribute, to patient harm;
• the patient safety risks associated with AVT; and
•  how accountability for AVT safety is understood locally and nationally.

As the investigation’s focus is on generic AI systems, we expect that this will mean AVT which is not classified as a medical device and subject to the additional post-market surveillance which comes with that regulatory regime. 

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