When does wellness AI become a medical device?
Reflections from the MHRA AI Airlock simulation workshop

Last week, representatives from across the healthcare and AI ecosystem gathered for the first of three Phase 2 Simulation Workshops as part of the UK Medicines and Healthcare products Regulatory Agency (MHRA) AI Airlock programme.
The session brought together regulators, developers, clinicians, academics, and public and patient representatives to explore one of the most complex issues emerging in digital health: where the boundary sits between wellness AI and AI that becomes a regulated medical device.
Dr Paul Sacher, Founder of Sacher AI, was invited to participate in the workshop as an expert contributor based on his experience developing and evaluating patient facing conversational AI systems. His work spans both academic research and real world deployment of AI in healthcare settings, with a particular focus on clinical and behavioural safety in human AI interactions.
The AI Airlock is the MHRA’s first regulatory sandbox. It is designed to work alongside developers to better understand emerging AI as a Medical Device (AIaMD) technologies and help address regulatory challenges in a responsible, patient centred way.
The programme is currently in its second phase, working with seven AIaMD developers.
Two companies from the cohort took part in the workshop. TORTUS demonstrated its clinician facing AI system designed to support clinical documentation, while Numan presented its digital health platform delivering remote patient care. These demonstrations helped ground the discussion in real product scenarios and practical regulatory questions.
A central theme of the discussion was intended use. In medical device regulation, intended use determines whether a system qualifies as a medical device, how it is classified, what evidence is required, and how it must be monitored once deployed.
For AI systems, particularly large language model based conversational systems, intended use is rarely static.
Products evolve. Features expand. Systems become integrated into clinical workflows. Outputs begin to influence users, clinicians, or treatment decisions in new ways.
A system that initially sits within the wellness category can gradually cross into medical device territory, sometimes without a single clear moment where that shift occurs.
Another major focus of the workshop was post market surveillance.
Regulators increasingly expect companies to demonstrate how they monitor their AI systems once deployed and how they identify, track, and respond to risks over time. This responsibility extends across the full product lifecycle.
For teams deploying conversational AI at scale, this creates practical challenges.
Risks in large language model systems often emerge gradually across many interactions rather than appearing as a single obvious failure. In many cases, relying solely on manual review of conversations or retrospective audits is unlikely to be sustainable.
Monitoring systems therefore need to detect patterns, trends, and behavioural signals across thousands or millions of interactions.
This challenge is becoming increasingly visible across healthcare AI more broadly.
As AI systems become embedded into care pathways, even subtle product changes can shift the regulatory position of a system. Expanding features, integrating with clinical services, or increasing the influence of system outputs can all move a product closer to the regulatory definition of a medical device.
One of the most valuable aspects of the session was the level of practical nuance in the conversation.
Participants discussed how seemingly small design choices or product updates can affect regulatory classification, and how difficult it can be to detect early signals that a system may be drifting across regulatory boundaries.
The workshop also highlighted the growing diversity of AI technologies entering healthcare, including ambient voice technologies and conversational AI systems.
Overall, the workshop offered a thoughtful and grounded look at the real challenges facing teams building AI systems for healthcare today.
The boundary between wellness products and regulated medical devices is becoming increasingly complex. Understanding where that line sits, and how systems may gradually move across it, will be critical for companies developing AI in health and clinical contexts.
At Sacher AI, we work with organisations developing AI systems that interact directly with patients, clinicians, and health consumers. Our focus is on helping teams design, evaluate, and monitor these systems so that safety, behavioural impact, and regulatory expectations are addressed from the earliest stages of development.
As regulatory expectations evolve, building systems that are not only innovative but also demonstrably safe, transparent, and monitorable will become essential.
If your organisation is developing AI systems that interact directly with people in healthcare settings, you can learn more about Sacher AI’s work supporting safe and responsible AI deployment at https://sacher.ai.
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