Andrew Bowdler, MIAA's Principal Data Analyst writes;  Today, the Medicines and Healthcare products Regulatory Agency, (MHRA) published new guidance clarifying how Ambient Voice Technology (AVT) products should be classified under existing UK medical device regulations. 

Importantly, AVT products used solely to transcribe consultations, summarise conversations, draft correspondence, or suggest clinical codes for clinician review are not considered medical devices under the current regulatory framework. However, where an AVT product supports diagnosis, treatment decisions, prevention, or takes automated clinical actions, it remains subject to medical device regulation.

For NHS organisations, suppliers, and assurance professionals, this is a welcome step. Innovation thrives when expectations are clear. The guidance helps distinguish between technologies that primarily support administrative workflows and those that directly influence clinical decision-making, enabling organisations to make more informed governance, procurement, assurance, and risk management decisions.

At MIAA, we see this as another example of why AI governance must be viewed as more than regulatory compliance. Whether a solution falls inside or outside medical device regulation, organisations still need robust assurance around data protection, clinical safety, cybersecurity, transparency, accountability, and operational risk. 

The question should never be "Is this regulated?" but rather "Can we demonstrate it is safe, effective, and trustworthy?" As adoption of AI scribes and ambient voice solutions accelerates across the NHS, the strongest implementations will be those that combine innovation with proportionate governance. Clear regulation provides the foundation; effective assurance builds the confidence to scale.

The conversation is now moving beyond whether AI can support clinicians and towards how we deploy these tools safely, responsibly, and at scale.

Source: MHRA's new guidance on Ambient Voice Technology-enabled Products, published 29 July 2026, developed in partnership with NHS England to clarify the regulatory status of AVT solutions used in health and care settings.