Executive summary
The adoption of "ambient scribing" or Ambient Voice Technology (AVT) in UK healthcare is accelerating, but it is now governed by a clear and robust set of rules. NHS England’s April 2025 guidance has framed the principles for adoption, mandating a full risk assessment (DCB0160), evidence of supplier safety (DCB0129), a formal medical-device determination, and compliance with the DSPT and DTAC frameworks (NHS England).
Reinforcing this, a June 2025 Priority Notification from NHS England requires that any AVT tool performing clinical summarisation must be registered as at least an MHRA Class I medical device. It also mandates that any non-compliant deployments must be paused immediately. While CE marks are still recognised in Great Britain for many devices until mid-2028, suppliers must follow UK routes for registration and compliance. This guide provides a practical roadmap for navigating this new regulatory landscape.
What is an AI scribe and what does NHS guidance say?
An AI scribe, or AVT, is a tool that uses artificial intelligence to listen to a clinical consultation and automatically convert the conversation into a structured output. The typical functions include: transcribe → summarise → suggest codes → draft letters → write-back to the EPR.
The NHS guidance is clear that while these tools can significantly reduce administrative workload and improve the quality of documentation, the outputs must always remain under clinician review. The legal and professional liability for the content of the patient record remains with the organisation and the responsible clinician (NHS England).
Compliance, at a glance: what “good” looks like in the UK
- Medical device status: A tool that only performs transcription may not be a medical device. However, any tool that summarises the consultation is likely to be one. The June 2025 NHS notification mandates that such tools must be registered as at least an MHRA Class I device and bear a UKCA mark (or a still-valid CE mark).
- Clinical safety: The supplier must provide a DCB0129 clinical safety case and hazard log. The adopting NHS organisation must complete a DCB0160 safety case, which includes a local hazard log and the appointment of a Clinical Safety Officer (CSO).
- DTAC baseline: Any tool procured by an NHS organisation must pass the Digital Technology Assessment Criteria, which covers five pillars: clinical safety, data protection, technical security, interoperability, and usability.
- DSPT & IG: The supplier must have a completed Data Security and Protection Toolkit submission. The adopting organisation must complete a Data Protection Impact Assessment (DPIA) before deployment.
NHS-ready AI scribes: public compliance signals to look for
Editor’s note: The regulatory landscape is fast-moving. Always verify a vendor's claims in the official MHRA Public Access Registration Database (PARD) and request their current compliance artefacts (DCB0129 safety case, DTAC pack, DSPT status, and cyber certificates) as part of your due diligence.
- Accurx Scribe (powered by Tandem Health): Publicly claims MHRA Class I registration (GMDN 36216) for the Tandem engine and makes its DTAC, DSPT, and cyber artefacts available in its support pages.
- T-Pro Copilot: States its compliance with NHSE AVT requirements and notes it is undergoing the MHRA Class I registration process.
- Lexacom: Asserts its compliance with NHS AI guidance and assurance standards. Users should check the specific device status for its ambient AI features.
- G2 Speech (SpeechAmbient): Has announced MHRA Class I registration for its ambient tools in company communications.
- Microsoft Dragon/DAX Copilot: While widely available, UK organisations must verify its specific UK MHRA device status before any clinical deployment.
- TORTUS: This UK start-up has a stated MHRA Class I registration with an intent to progress to Class IIa. This should be confirmed via PARD and the supplier's evidence pack.
The procurement playbook (NHS)
- Decide device status & risk class: If the tool summarises, it is a Software as a Medical Device (SaMD). Confirm its UKCA/CE mark and MHRA registration.
- Collect supplier artefacts: Request the full compliance pack: DCB0129 safety case, DTAC evidence, DSPT status, and Cyber Essentials Plus/CREST penetration test results.
- Appoint a Clinical Safety Officer (CSO) and complete your local DCB0160, including a DPIA and a local safety case.
- Assess integration: Check its compatibility with your EPR (EMIS, SystmOne, etc.) and its ability to handle standards like FHIR, HL7, and SNOMED. Ensure it provides a clear audit trail.
- Confirm data handling: The vendor must be UK GDPR compliant and have clear policies on data retention, minimisation, and a guarantee that patient data will not be used for model retraining without lawful agreement.
- Plan for monitoring: The vendor must have a plan for Post-Market Surveillance. You must have a process for reporting incidents via the LFPSE or Yellow Card systems.
What to avoid: red flags in AI scribe proposals
- "Free trials" for tools that perform summarisation but cannot provide an MHRA Class I registration number.
- Vague promises of a DCB0129/DTAC pack being "coming soon."
- Unclear data residency or data processing agreements.
- The use of any consumer-grade apps outside of organisational governance, which is explicitly discouraged by NHS England.
Evidence & impact: what early data and policy say
While large-scale, peer-reviewed evidence is still emerging, promising signals from early pilots point to a significant reduction in administrative burden and cognitive load for clinicians (PubMed Central, The Guardian). The clear policy intent from NHS England is to scale the use of assured AVT to drive productivity, not to relax the standards for safety and governance.
Quick comparison table
| Product | MHRA Status (Claimed) | DCB0129 | DTAC | DSPT | Cyber (CE+) | EPR Integration |
|---|---|---|---|---|---|---|
| Accurx Scribe | Class I | Yes | Yes | Yes | Yes | EMIS/S1 |
| T-Pro Copilot | In progress | Yes | Yes | Yes | Yes | Multiple |
| Lexacom | Check status | Yes | Yes | Yes | Yes | Multiple |
| G2 Speech | Class I | Yes | Yes | Yes | Yes | Multiple |
| TORTUS | Class I | Yes | Yes | Yes | Yes | Multiple |
(Status last checked: August 2025. Always verify via MHRA PARD and direct vendor contact.)
FAQs
- Do all AI scribes need MHRA approval?
- If they perform summarisation or otherwise inform clinical decisions, they are likely to be classified as a medical device. NHS England requires a minimum of Class I registration for any summarising scribe.
- Is a CE mark acceptable in England?
- Yes, for now. For many devices, a valid CE mark is acceptable for placing a product on the Great Britain market until 30 June 2028. However, all devices must still be registered with the MHRA.
- What must my organisation complete before go-live?
- You must have the supplier's DCB0129, and you must complete a local DCB0160 (which includes a DPIA and a clinical safety case) and appoint a CSO. You must also complete the DTAC and DSPT checks.
- What about Wales or Scotland?
- Wales issued its own parallel AVT guidance in August 2025. Always check the policies of your specific devolved nation.