The U.K. Now Classifies Ambient Voice Technology As SaMD
By Benjamin Austin, senior QA/RA consultant (SaMD/AI), IMed Consultancy
Ambient voice technology (AVT) has the potential to be a transformative force in healthcare, promising a future where administrative burdens are alleviated and clinicians can focus more on patient care than paperwork. By capturing and transcribing clinician-patient interactions, these AI-driven systems can in fact streamline documentation, save time, and enhance clinical workflows.
AVT is part of a broader wave of AI-assisted tools revolutionizing healthcare delivery. Unlike conventional speech-to-text software, modern AVT leverages natural language processing and machine learning to not only transcribe but also summarize and interpret spoken dialogue between clinicians and patients.
This summarization capability is particularly powerful. It allows for the automatic generation of clinical notes, freeing clinicians from the time-consuming task of manual documentation. Some AVT solutions even integrate directly into electronic patient record (EPR) systems, allowing seamless updates and reduced duplication of effort.
The benefits of such innovation are clear: reduced administrative overhead, improved data consistency, and more face-to-face time between clinicians and patients. In a system under strain from staffing shortages and budgetary constraints, these advantages are not trivial.
However, the U.K. Medical Devices Regulations 2002 (U.K. MDR 2002) do not adequately address the specific characteristics and risks associated with modern digital technologies. Software as a medical device (SaMD) and emerging tools like AVTs remain underserved by the current framework, which lacks clear definitions, classification rules, and guidance tailored to these innovations. As a result, there is ongoing uncertainty around regulatory expectations for these technologies.
A Regulatory Wake-Up Call
On April 27, 2025, NHS England issued new guidance developed in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA).1 The core message was unambiguous: AVT tools that go beyond mere transcription to include summarization are to be classified as SaMD.
Under U.K. medical device regulations, any software that has a medical purpose qualifies as a medical device and must undergo appropriate conformity assessment processes (MHRA, 2021). This includes meeting UKCA or CE marking standards, maintaining a technical file, and undergoing clinical safety assessments.
The NHS England guidance explicitly sets out requirements for AVT tools, including:
- MHRA Class I medical device registration for summarization-capable tools
- completion of DCB0160 (clinical safety) and DPIA (data protection impact) assessments
- platform assurance via Digital Technology Assessment Criteria (DTAC), Data Security and Protection Toolkit (DSPT), or Cyber Essentials Plus
- approval through local integrated care board (ICB) or trust governance structures.
In short, the NHS no longer views AVT as a mere productivity enhancer but as clinical tool with patient safety implications that must be treated, and regulated, as such.
In addition to this, on June 9, 2025, the national chief clinical information officer issued a Priority Notification requiring the immediate cessation of any AVT product that failed to meet compliance standards. The notification warned that continued use of noncompliant tools could render both organizations and individual clinicians personally liable for any resulting risk or harm, suggesting a zero-tolerance approach to unregulated AI deployment.
What Does It Mean For AVT Providers?
For AVT vendors, particularly startups unfamiliar with the medical device regulatory landscape, the sudden change represents a major strategic pivot. To avoid being excluded by NHS procurement, many are now rushing to register their products as Class I medical devices via the MHRA’s Public Access Registration Database (PARD) with the aim of compiling all documentation at a second date.
However, this approach carries its own risks. While Class I registration allows for self-certification, vendors must maintain a detailed technical file demonstrating conformity with U.K. Medical Device Regulations. The MHRA can request this documentation at any time, and failure to provide it may result in fines or exclusion from the NHS procurement pipeline.
Furthermore, the self-certification model places the burden of compliance squarely on the manufacturer. Without robust clinical evaluation, risk management documentation, and post-market surveillance plans, the product remains exposed to regulatory scrutiny.
Additionally, as AVT continues to evolve, the likelihood of these tools falling within the scope of regulated medical devices grows significantly. What may begin as a simple transcription service can quickly develop into a more sophisticated platform capable of summarization, clinical decision support, and more. Each of these functionalities carries potential clinical impact, thereby triggering regulatory classification under the U.K. Medical Device Regulations.
However, many AVT vendors are early-stage startups, lacking familiarity with the nuances of medical device regulations and are not used to factoring regulatory obligations into product development cycles. As a result, compliance is sometimes viewed as an afterthought, posing risks not only to patient safety and data governance but also to the commercial viability of the product, as noncompliant tools risk being barred from NHS procurement or subject to enforcement by the MHRA.
Aligning Regulations And Innovation
This situation is emblematic of a wider challenge facing health systems globally: how to integrate rapid technological innovation into highly regulated clinical environments.
On one hand, innovation is essential to meet rising demand, aging populations, and workforce shortages. Technologies like AVT offer real potential to augment clinical capacity, reduce errors, and improve care continuity. On the other hand, regulation exists for a reason. Medical software that can potentially influence clinical decision-making must be safe, secure, and evidence based.
Regulators must therefore be agile enough to respond to new modalities of care without stifling innovation. Meanwhile, vendors and clinicians must take compliance seriously, not as a bureaucratic hurdle but as a vital part of building trust and ensuring safety.
A more substantive shift is on the horizon with the introduction of the new U.K. Medical Device Regulations, expected to come into force in 2026. This modernized framework is poised to replace the outdated U.K. MDR 2002, providing a clearer legal basis for categorizing and regulating SaMD as well as dedicated MHRA guidance for AI development and deployment.
In the meantime, NHS England’s recent guidance signals a transition from the experimental phase of AI adoption to a more mature regulated model, where digital tools are recognized as integral component of clinical care with potential implications for patient safety and legal accountability. This means that providers of AVT tools, and SaMD in general, can no longer put off investments in compliance, whether by developing internal expertise or engaging with external consultants. Failure to do so not only risks product withdrawal and reputational damage but could also result in long-term exclusion from procurement frameworks and even regulatory enforcement.
Reference
- NHS England, Guidance on the use of AI-enabled ambient scribing products in health and care settings, April 27, 2025, https://www.england.nhs.uk/long-read/guidance-on-the-use-of-ai-enabled-ambient-scribing-products-in-health-and-care-settings/
About The Author
Benjamin Austin is IMed Consultancy’s newest senior QA/RA consultant, with 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.