Sounding a Call to Action for Ambient Voice Technology

In high-pressure but often understaffed environments such as healthcare, technologies that automate repetitive basic tasks, such as note-taking, can play a key role in easing the burden on nursing staff and clinicians as well as improving productivity. Ambient voice technology (AVT) is a type of technology that leverages natural language processing to not only transcribe but also summarize and interpret spoken dialogue between clinicians and patients.

This summarization capability is a powerful improvement on conventional speech-to-text software and enables the generation of clinical notes. Some AVT solutions can also integrate directly into electronic patient record (EPR) systems, so updates are added seamlessly, reducing time spent on manual documentation for clinicians and avoiding duplicate efforts.

Given a lack of clarity concerning the classification and regulation of AVTs in the UK Medical Devices Regulations 2002 (UK MDR 2002), on April 27, 2025, NHS England issued new guidance developed in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA). This was followed by a Priority Notification by the National Chief Clinical Information Officer requiring the immediate cessation of any AVT product that failed to meet compliance standards.

The new guidance is of concern to all AVT providers that are currently in or planning to enter the UK market. It clearly states that AVT tools that provide anything more than basic transcription and, for example, include summarization capabilities, should be classified as Software as a Medical Device (SaMD) and comply with all relevant requirements. As such, AVTs must be UKCA or CE marked, maintain a technical file, and perform clinical safety assessments. Specifically, AVT tool requirements include:

• MHRA Class I medical device registration for summarization-capable tools
• Completion of DCB0129 (clinical safety) and DPIA (data protection impact) assessments
• Platform assurance via DTAC, DSPT, and Cyber Essentials Plus
• Approval through local Integrated Care Board (ICB) or Trust governance structures

The risk of continued use of non-compliant tools is high, as regulations could render both organizations and individual clinicians personally liable for any resulting risk or harm. To remain on the market, AVT vendors are rushing to register their products as Class I medical devices via the MHRA’s Public Access Registration Database (PARD) with the objective of compiling all documentation in short order. Self-certification, however, needs to be carried out rapidly and effectively as vendors are required to maintain a detailed technical file demonstrating conformity with UK Medical Device Regulations. The latter can be requested by the MHRA at any time, with failure to comply potentially resulting in fines or even exclusion from NHS procurement. As many AVT vendors are early-stage startups, preparing and maintaining the documentation required for compliance can be a heavy burden for which they also lack the required expertise.

In addition to this, the UK’s Medical Technologies Regulatory Reform Roadmap (December 2024) outlines a roadmap for delivering clearer, more robust guidance on areas such as AI development and deployment, and cybersecurity, confirming the intention to develop a more structured regulatory framework for digital medical device regulation and SaMD. The new UK Medical Device Regulations, expected to come into force in 2026, will replace the outdated UK MDR 2002 and provide clearer rules for categorizing and regulating SaMD as well as guidance for AI development and deployment.

As regulators focus on developing regulations for innovative technologies, the landscape can prove complex and changeable. AVT developers and SaMD providers with a footprint in the UK market will need to invest in expertise or external support to ensure that they are always ahead of this changing environment and prevent any potential reputational damage or product withdrawal through lack of regulatory preparedness.

Benjamin Austin is IMed Consultancy’s newest senior QA/RA consultant, bringing eight years of specialized experience in Software as a Medical Device (SaMD) and AI-driven healthcare solutions. He has worked extensively with startups on innovative projects, including AI tools for Alzheimer’s detection and drug dose optimization. With a strong background in quality assurance, regulatory affairs, clinical investigations, and data protection, Austin plays a key role in guiding digital health innovators through the complex regulatory landscape.