Which of these modules would be a medical device
An honest answer to the first question anyone serious asks about this concept — including the parts that are inconvenient. Assessed against published UK criteria, with the source and date for each.
Last checked against its sources on .
The short version
Of the six modules described on this site, two are clearly outside the UK medical device regulations, two sit on a boundary that the implementation decides, and two are inside as they were originally described. Nothing here is certified, because nothing here is built.
The reason this matters more than it might seem: the MHRA test turns on intended purpose and the claims a manufacturer makes, not on the technology. Identical software can be regulated or unregulated depending on what its marketing says — so the wording on a website is part of the regulatory position, not separate from it.
The test being applied
Outside the regulations
- Recording, transcribing and summarising a clinical conversation
- Formatting or organising information for a clinician to review
- Suggesting diagnosis codes for terms expressly mentioned during the consultation
- Presenting information for a clinician to review, edit and approve before it enters the record
Inside the regulations
- Generating new medical information, such as suggested diagnoses or treatment options
- Autonomously determining follow-up tests, or placing orders, without clinician confirmation
- Entering information into a patient record without clinician review
- Any claim that the product guides diagnosis or treatment planning
Source: MHRA guidance on Ambient Voice Technology, 29 July 2026.
Module by module
| Module | Assessment | Why |
|---|---|---|
| AI Clinical Scribe | Outside the regulations | Transcribing a consultation, drafting a note and suggesting codes for terms that were actually said all fall on the unregulated side of the test — provided a clinician reviews and approves before anything reaches the record. Remove that review step and it moves inside. |
| AI Practice Manager Support | Outside the regulations | Answering questions about NHS policy, CQC guidance and internal procedure is an administrative purpose. There is no medical purpose, so the medical device definition is not engaged. |
| AI Coding & Billing Assistant | On the boundary | Suggesting codes that reflect what was said is explicitly outside. Inferring a clinical conclusion that was not stated — deriving a diagnosis in order to code it — would be generating new medical information, which is inside. The distinction is in the implementation, not the description. |
| AI Predictive Analytics | Depends on scope | Forecasting appointment demand and staffing is an operational purpose and sits outside. Predicting risk for an individual patient is a medical purpose and sits inside. The two must be kept apart deliberately, because a single feature can cross the line without anyone deciding to. |
| AI Patient Triage | Inside, if it prioritises clinically | Sorting requests by administrative category is outside. Deciding clinical urgency, or routing a patient on the basis of their symptoms without a clinician confirming, is autonomous clinical decision-making and is inside. This module was previously described as “safe, automated triage”; both the safety claim and the autonomy have been removed from that description. |
| AI Differential Diagnosis Assistant | Inside, unambiguously | Surfacing differential diagnoses from symptoms and history is the guidance’s own worked example of generating new medical information. There is no framing of this module that puts it outside the regulations. It could not be released without conformity assessment and a UKCA mark. |
What is held today
Nothing on this list. It is written out in full rather than summarised, because a buyer needs the specific gaps rather than a general disclaimer:
- UKCA marking or MHRA device registration
- DCB0129 clinical safety case, or a named clinical safety officer
- DTAC assessment
- DSPT submission or Cyber Essentials certification
- ISO 13485 or ISO 27001
- A listing on the AVT Supplier Registry
- Integration with any clinical system
What reaching the market would require
In the order the work has to happen. The first step governs every one after it — a buyer who skips it risks building a quality system for the wrong classification.
- Fix the intended purpose
Decide, in writing, what each module is for and what it claims. This single decision determines whether the rest of this list is a short exercise or a two-year programme, and it is cheaper to get a qualified regulatory opinion now than to discover the answer during an audit.
MHRA guidance on Ambient Voice Technology · 29 July 2026
- UKCA conformity assessment, where a module is in scope
A module that generates medical information needs conformity assessment through a UK Approved Body, with the quality management system that goes alongside it. Suppliers already in this market hold Class IIa certification for products narrower than the concept described here.
MHRA guidance on Ambient Voice Technology · 29 July 2026
- DCB0129 clinical safety case
The manufacturer-side clinical safety standard: a safety case, a hazard log, and a named clinical safety officer. Required of suppliers of digital health products in England.
NHS England — guidance on AI-enabled ambient scribing products · published 27 April 2025, updated 29 July 2026
- DCB0160 at the deploying organisation
The deploying organisation completes its own safety documentation, hazard log and monitoring framework. A supplier who cannot support this makes their customer’s job impossible.
NHS England — guidance on AI-enabled ambient scribing products · published 27 April 2025, updated 29 July 2026
- Data Protection Impact Assessment
Required before processing. For an ambient scribe it has to address recording patients, lawful basis, consent, retention and the position of any sub-processor.
NHS England — guidance on AI-enabled ambient scribing products · published 27 April 2025, updated 29 July 2026
- Digital Technology Assessment Criteria (DTAC)
The NHS baseline covering clinical safety, data protection, technical security, interoperability and usability. Expected of suppliers and referenced by the AVT registry.
NHS England — guidance on AI-enabled ambient scribing products · published 27 April 2025, updated 29 July 2026
- Data Security and Protection Toolkit, and Cyber Essentials
DSPT compliance plus Cyber Essentials certification. Established suppliers in this category generally hold Cyber Essentials Plus and ISO 27001 as well.
NHS England — guidance on AI-enabled ambient scribing products · published 27 April 2025, updated 29 July 2026
- Apply to the AVT Supplier Registry
The registry is how NHS organisations find and assess suppliers of ambient scribing products. 27 suppliers were listed as at 21 August 2026, and applications reopened on 3 February 2026 and remain open.
NHS England — Ambient Voice Technology Self-Certified Supplier Registry · page updated 21 August 2026
- Clinical system integration
Not a regulatory requirement, but the practical one. Writing into EMIS Web or TPP SystmOne is what makes a scribe usable in general practice, and it is slow enough that suppliers who have done it treat it as a competitive asset.
Questions this page answers
- Are the GP Support modules regulated medical devices?
- Three of the six would be, as described. Under the MHRA’s Ambient Voice Technology guidance of 29 July 2026, transcription, summarising and coding what was expressly said sit outside the medical device regulations; generating suggested diagnoses, deciding clinical urgency autonomously, or claiming to guide diagnosis and treatment planning sit inside them.
- Does GP Support hold any regulatory certification?
- No. There is no UKCA marking, no MHRA registration, no DTAC assessment, no DCB0129 safety case, no DSPT submission, no ISO certification and no listing on the NHS England AVT Supplier Registry. No software has been built, so none of these has been sought.
- How does a supplier reach the NHS market for ambient scribing?
- Through the NHS England Ambient Voice Technology Self-Certified Supplier Registry, which NHS organisations use to find and assess suppliers. Its public listing named 27 suppliers as at 21 August 2026. Reaching it requires the DTAC, clinical safety and data protection work set out on this page, and UKCA conformity assessment for any function that is a medical device.
Sources
- MHRA guidance on Ambient Voice Technology · 29 July 2026
Sets out when an AVT product is a medical device, on the basis of intended purpose and manufacturer claims.
- NHS England — guidance on AI-enabled ambient scribing products · published 27 April 2025, updated 29 July 2026
Sets the adoption requirements for health and care settings: DTAC, clinical safety standards, DPIA, DSPT and Cyber Essentials.
- NHS England — Ambient Voice Technology Self-Certified Supplier Registry · page updated 21 August 2026
The list NHS organisations use to find and assess suppliers in this category. 27 suppliers listed; applications reopened 3 February 2026.
This is not regulatory or legal advice. It is a reasoned reading of published criteria by the people who built this demonstrator, offered so that a prospective buyer starts from the real position rather than discovering it later. Anyone intending to build or sell any of these modules should obtain a qualified regulatory opinion on intended purpose before committing to engineering.