New MHRA guidance on regulation of Ambient Voice Technology (AI Scribes)

The MHRA today released new guidance (AVT Guidance) on Ambient Voice Technology (AVT) products and the circumstances in which these do and do not qualify as medical devices under the UK Medical Devices Regulations 2002 (UK MDR). 

AVT products are AI-powered tools (commonly leveraging the same Large Language Models used in AI chatbots such as OpenAI’s ChatGPT and Anthropic’s Claude) used to automatically capture and convert spoken words into text and/or other outputs. AVT products are increasingly used in healthcare to support clinical documentation and workflows.

The MHRA seeks to clarify a rapidly expanding market sector after uncertainty was introduced by the MHRA in February 2025 as a result of ambiguously written guidance on Digital Mental Health Technologies (DMHT Guidance). This was then compounded by the introduction of dedicated AVT guidance by NHS England, which gave a contentious account of the application of UK MDR to AVT products. In effect, NHS England considered that all AVT products qualified as medical devices. The MHRA has separately updated the DMHT Guidance today to bring it into line with the AVT Guidance. NHS England has also revised its guidance to remove its explanation of how UK MDR applies to AVT products.

Notably, the AVT Guidance only interprets the legislation which is applicable in Great Britain. It does not apply to Northern Ireland, which is subject to the EU Medical Devices Regulation (EU) 2017/745 (EU MDR). This is in contrast to the DMHT Guidance, which presented the MHRA’s undifferentiated view on qualification of certain digital mental health technologies as medical devices under both UK MDR and EU MDR. This may be symptomatic of ongoing uncertainty as to how the EU will interpret EU MDR in relation to AVT products. 

Content of the AVT Guidance

To a great extent, the new guidance simply reiterates existing dogma: 

1. Like all software, an AVT product only qualifies as a medical device if it has a medical intended purpose.  
2. Whether a product has a medical intended purpose is defined by the claims made in its instructions for use, labelling, and the manufacturer’s promotional materials.
3. The product’s functionality is a relevant factor in assessing its intended purpose, but the mere fact that a product incorporates a particular technology (such as AI) does not mean that it has a medical intended purpose.
4. The mere fact that a product is used in healthcare systems does not mean that it has a medical intended purpose.
5. Disclaimers are not an effective way of limiting the intended purpose of a product if they contradict claims made or implied elsewhere in product labelling or marketing.

Most of the substance of the AVT Guidance lies in the illustrative examples of different types of AVT product and how UK MDR applies to them, which we explain further below.

However, there are also some noteworthy passages indicating how the MHRA thinks about intended purpose management as an aspect of risk management, even for products which do not have a medical intended purpose. 

First, the MHRA expects manufacturers to take account of the broad and flexible functionality of Large Language Models and the potential for foreseeable misuse of AVT products which incorporate them, and to introduce design measures to reduce the likelihood of misuse outside the scope of the AVT product’s intended purpose. 

Second, the MHRA treats general disclaimers (such as “not for diagnosis”) as a form of safety warning intended to reduce the risk of misuse, emphasising that these are inadequate risk mitigation measures where the risk could be mitigated through design choices or other protective measures.  

None of this is controversial to manufacturers of medical devices, who are required to manage foreseeable misuse of their medical device as part of their documented risk management plan. However, it is not clear exactly what the consequences of this guidance are for AVT products which do not qualify as medical devices, for which the developer may have no regulatory obligation to undertake risk management. While the MHRA is free to state its “expectations” for the performance of proper risk management by manufacturers of AVT products, it does not have any jurisdiction over software which does not qualify as a medical device. 

One possible interpretation is that, where a manufacturer fails to sufficiently limit the functionality of an AVT product to align with its intended purpose, the MHRA may consider this to be an implied claim that the AVT product has a medical intended purpose. On that basis, the AVT product would qualify as a medical device, bringing it within the MHRA’s jurisdiction. 

Another option is that failure to sufficiently limit the functionality of an AVT product to align with its intended purpose would place the manufacturer in non-compliance with its Clinical Risk Management system required by NHS technical standard DCB0129. Such non-compliance could disqualify the manufacturer from supplying its AVT product to NHS organisations. 

Examples of AVT products that do and do not qualify as medical devices 

The AVT Guidance provides examples of AVT products which do and do not qualify as medical devices, and provides relatively detailed reasoning explaining each conclusion. Each example of an AVT product that does not qualify as a medical device has a counterpart example of a similar AVT product that does qualify as a medical device, helping to elucidate common trigger points for an AVT product to qualify as a medical device. 

Examples 2 and 7 (set out in the table below) are particularly pertinent, as they highlight the importance of the claims made by the manufacturer in determining the regulatory status of an AVT product:

It is worth reading each of the examples provided in the guidance in full to see how the MHRA thinks about different types of AVT product. However, a few general principles can be derived from the examples:

• An AVT product which merely records and transcribes, summarises, formats or organises information from clinical consultations, and presents this information to a clinician for review, edit and approval, does not have a medical intended purpose. It is intended to assist the clinician with an administrative task.
  • This includes suggesting clinical diagnosis codes based on matching terms or information that were expressly mentioned during the consultation (e.g. condition names) to potentially applicable clinical diagnosis codes.
• If the manufacturer claims that the AVT product can help guide diagnosis and treatment planning, then the AVT product will qualify as a medical device even where it merely records and transcribes, summarises, formats or organises information from clinical consultations, and present this information to the clinician for review, edit and approval.
• An AVT product which generates new information that has a medical intended purpose, such as a suggested diagnosis or a treatment option, will qualify as a medical device.
• An AVT product which autonomously determines necessary follow-up tests and places the relevant orders without clinician input or confirmation will qualify as a medical device. 

In addition to the general principles set out above, Example 8 in the AVT Guidance also implies (but does not confirm) that an AVT product would qualify as a medical device where it merely records and transcribes, summarises, formats or organises information from clinical consultations, but it automatically enters information into the patient’s electronic health record directly without clinician review or approval. While the example is not clear, this seems likely to be the correct position. Without a human being in the loop, it is hard to say that such an AVT product is merely assisting with an administrative task. 

Final thoughts

The AVT Guidance is welcome. The DMHT Guidance and subsequent NHS England guidance introduced regulatory uncertainty for AVT product manufacturers, which held up adoption of AI technology in the NHS.

It is also welcome that the MHRA has provided so much reasoning as part of the AVT Guidance. This will make it much easier for manufacturers to apply the AVT Guidance to different permutations of AVT product that differ in various ways from the examples provided. 

The EU has not produced definitive guidance on the regulation of AVT products under EU MDR, despite longstanding rumours of an example under consideration by the Borderline Committee following a referral by the Norwegian competent authority. One hopes that this guidance from the MHRA will prompt the EU to finally reach a conclusion on the matter.