What the MHRA's AI scribe guidance means for medico-legal reports

What the MHRA said

On 29 July 2026 the Medicines and Healthcare products Regulatory Agency (MHRA) published guidance, developed with NHS England, on how existing medical device law applies to ambient voice technology (AVT) in health and care settings in Great Britain. AVT products are often called AI scribes. The MHRA states that the guidance clarifies current rules and does not change the law.¹

Which tools are medical devices

The line the MHRA draws is about what the product is intended to do.

• Not medical devices: products intended solely to transcribe, to summarise clinical conversations, to draft letters or to suggest clinical codes for a clinician to review.¹
• Medical devices: products intended to support diagnosis, treatment or prevention, or that take automated action, such as placing orders without clinician review. These must meet the relevant safety and performance requirements.¹

Organisations are also asked to watch for changes in a product’s functionality that could alter its regulatory status.¹

What the guidance does not say

“Not a medical device” does not mean “approved” or “accurate”. It only means the tool is outside medical device regulation. The MHRA says users of these products should still consider what information and practices are needed for safe deployment. It also asks NHS boards to confirm appropriate clinical oversight, local governance, staff training and sound procurement.¹ NHS England has also published its own guidance on using these products in England.²

The guidance is written for the NHS. It does not address medico-legal reports, instructions from solicitors or the duties of an expert witness. Those sit elsewhere. Our article on AI in expert reports covers what expert bodies are saying.

The point that matters most for reports

The MHRA is clear that clinicians remain responsible for reviewing and verifying AI-generated transcripts, summaries and other outputs before use.¹ The regulatory position does not move that responsibility. If you sign a report, you are answerable for every sentence in it, whichever tool drafted it.

What to do with this

• Find out what your tool is intended to do. A transcription and summary tool sits in a different category from one that suggests diagnoses or actions.
• Treat regulatory status as one question among several. Data protection, where audio is processed and how drafts are checked still need answers.
• Check the draft against the original audio before you sign, particularly for dates, doses, laterality and negatives such as “no” and “not”.

That last step is what our AI report validation service does. A human listens to the recording and checks the report against it.

Sources

1. MHRA: MHRA clarifies regulatory status of ambient voice technologies used in the NHS, GOV.UK, 29 July 2026
2. NHS England: Guidance on the use of AI-enabled ambient scribing products in health and care settings

Related services

• AI report validation: your report checked against the original audio
• AI report review: read, formatted and proofread
• Medico-legal transcription: your dictation typed by UK-based transcribers