Ambient Voice Technology (AVT) has seen a rise of popularity in clinical settings, mainly due to its potential to ease administrative burden by transcribing, and in some cases summarizing client-patient interactions, allowing healthcare professionals to save precious time to focus on patient care.
Unlike traditional speech-to-text tools, AVT leverages machine learning and natural language processing to summarize and interpret spoken language, enabling automatic generation of clinical notes and even integration with EPR (Electronic Patient Record) systems, further streamlining documentation.
These AI-based tools can therefore really make a difference for healthcare professionals, especially in the UK, with the NHS continuing to face staff shortages, with 43% of the NHS staff stated not to have enough staff at their organization for them to do their job properly according to Statista.
However, the proliferation and rapid adoption of AVT in clinical settings has not gone unnoticed, and NHS England has made it clear that the use of these tools must now meet stringent compliance standards.
On 27 April 2025 in fact, NHS England has released new guidance, developed in collaboration with the Medicine and Healthcare products Regulatory Agency (MHRA), outlining the safe and appropriate adoption of AVT and AI scribing technologies.
This move was made necessary by the fact that current UK regulations remain outdated when it comes to technological innovation, with inadequate provision for Software as a Medical Device (SaMD) and AI-based tools. This lack of clear guidelines resulted in many AVT tools being marketed as non-medical productivity tools, allowing them to enter clinical environments without UKCA or CE marking.
The new guidance, however, clarified that AVT tools that offer more than pure transcription, leveraging AI and NLP to include summarization are now to be considered Software as a Medical Device and need to adhere to strict compliance requirements. These tools are not seen as simple productivity enhancer but as tools with clinical and patient safety implications that need to be regulated as such. Specifically, under the UK MDR, any software providing diagnostic or therapeutic support is classified as a medical device and thus subject to the conformity assessment processes, including meeting UKCA or CE marking standards, maintaining a technical file, and undergoing clinical safety assessments.
Despite this guidance, the NHS has noticed AVT tools that fail to meet the required standard continued to be deployed in clinical settings and on 9 June 2025 the National Chief Clinical Information Officer issued a Priority Notification mandating the immediate cessation of any AVT product that lacks at least MHRA Class I medical device registration (if summarization is performed), has not completed clinical safety (DCB0160) and data protection (DPIA) assessments, fails to meet platform assurance standards such as DTAC, DSPT, or Cyber Essentials Plus, or has not been approved through relevant ICB or Trust governance channels.
The notice confirms a zero-tolerance approach to unregulated AI-powered tools deployment, warning that non-compliant tools could render both organization and clinicians liable for resulting risk or harm to patients.
As a result, US providers with ambition to introduce their technology in the UK must be aware that the new rules are not optional, but prerequisite for market access. AVT solutions now must be registered at least as Class I medical devices, often under the category of Digital Dictation Systems (as listed in the MHRA’s Public Access Registration Database – PARD). Many vendors are already rushing to register their device, often planning to compile all relevant documentation shortly after. However, while Class I products are self-certified, manufacturers are still required to maintain a comprehensive technical file to prove compliance, that the MHRA can request to review at any time.
For US vendors, this means compliance planning cannot be an afterthought, and aligning product development with UKCA and EU CE marking requirements will be crucial, particularly since the upcoming UK Medical Device Regulation, expected in 2026, is anticipated to introduce stricter requirements for SaMD and AI-based technologies, potentially increasing the classification of AVT systems and expanding the regulatory burden on manufacturers seeking UKCA marking
However, as many AVT providers are start-ups lacking familiarity with medical device regulations, they are not used to factoring compliance in product development cycles, ultimately posing risks not only to patient safety and data governance but also to the commercial viability of the product if destined to clinical settings.
This situation has highlighted the need to align rapid technological innovation and medical devices regulations, not just in the UK but worldwide. US providers should therefore not treat AVT as just another productivity tool, but as a potentially regulated clinical technology and should be careful not to exceed the bounds of current regulatory status in their chosen market to avoid inadvertently moving into the medical device space.
Preparing early, by investing in compliance, either by establishing a dedicated internal team or relying on external, experienced consultants, will mean to be better positioned to take full advantage of AVT’s potential in a safe, sustainable and compliant way.
Photo: Niyazz, Getty Images
Benjamin Austin is IMed Consultancy’s newest Senior QA/RA Consultant, bringing 8 years of specialised 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 optimisation. With a strong background in quality assurance, regulatory affairs, clinical investigations, and data protection, Benjamin plays a key role in guiding digital health innovators through the complex regulatory landscape.
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