This is a living reference tracking the UK regulatory status of the main AI scribe and ambient voice technology (AVT) tools. For each, it shows the regime (UKCA or EU MDR), the class, the certifying body, the scope and date, and a plain-English note on what the class means for you. Regulatory status changes, so treat this as a maintained snapshot and always confirm against the MHRA's public register and the vendor before procurement. Last updated: 25 June 2026.
Key takeaways
- TORTUS is the first AVT certified UKCA Class IIa, assessed by Scarlet (UK Approved Body 8536), on 24 June 2026.
- Tandem holds EU MDR Class IIa (CE marked) for its scribe and coding assistant, accepted in GB until 30 June 2028.
- Heidi is a self-declared Class I device, with Class IIa reported to be in progress.
- "Registered", "self-declared" and "certified" mean different things, and the difference matters.
- Always verify status against the MHRA register and the vendor before you rely on it.
The tracker
| Tool | Regime | Class | Certifying body | Scope | Date | What it means for you |
|---|---|---|---|---|---|---|
| TORTUS | UKCA | Class IIa | Scarlet (UK Approved Body 8536) | Documentation plus clinical decision-support | 24 Jun 2026 | Independently assessed for a higher-risk intended purpose; still requires human verification |
| Tandem Health (AI Scribe) | EU MDR (CE) | Class IIa | EU notified body | AI scribe; coding assistant and CDS also Class IIa | Scribe 21 May 2026; coding assistant Feb 2026 | CE marked and MHRA registered; CE accepted for GB use until 30 Jun 2028 |
| Accurx Scribe (powered by Tandem) | EU MDR (CE), via Tandem | Class IIa | Via Tandem's notified body | Scribe and coding within Accurx | 2026 | Runs on Tandem's certification; MHRA registered; widely deployed across GP practices |
| Heidi Health | UKCA / MHRA | Class I, self-declared (Class IIa reported in progress) | Self-declared (MHRA registered) | Summarisation | Registered; IIa in progress | Low-risk self-declaration; states it does not generate diagnoses or referrals autonomously |
| Dragon Copilot (Microsoft/Nuance) | Enterprise; GB status to confirm | To confirm | To confirm | Documentation and workflow automation | Not confirmed here | Confirm GB MHRA registration, class and certified scope directly with the vendor |
| Ambience Healthcare | Primarily US; GB status not established | Not established (GB) | Not applicable here | Documentation | Not confirmed here | US-focused enterprise tool; verify any GB registration and scope before use |
Where a cell says "to confirm" or "not established", it means we could not verify that status from an authoritative source at the last update, not that the tool lacks it. Check with the vendor and the MHRA register.
How to read this: certified, registered and self-declared
These three words are often used loosely, but they mean different things:
- Registered means the device is listed on the MHRA's database. Every medical device placed on the Great Britain market must be registered, whatever its class. Registration alone is not an assessment of the device.
- Self-declared applies to Class I. The manufacturer assesses its own conformity and holds the technical documentation, with no Approved Body reviewing the file. The device must still be registered with the MHRA.
- Certified applies to Class IIa and above. An independent Approved Body (under UKCA) or notified body (under EU MDR, for CE marking) has assessed the quality management system and technical documentation and issued a certificate.
So a Class I tool that is "MHRA registered" has self-declared, while a Class IIa tool has been independently certified. Both are legitimate; they represent different levels of external scrutiny for different levels of risk.
Methodology and maintenance
Entries are compiled from vendor statements, official regulatory sources and NHS England guidance, and dated to the last verification. This tracker is a snapshot maintained over time, not a substitute for primary checks. Two authoritative places to verify are the MHRA's public device register and, for NHS deployment, the NHS England AVT Supplier Registry, which lists self-certified suppliers and requires at least MHRA Class I registration and a completed DTAC assessment. Regulatory status can change quickly, particularly as tools move from Class I toward Class IIa, so confirm before you procure or rely on any entry.
Update log
- 25 Jun 2026: Added TORTUS UKCA Class IIa certification (Scarlet, UK Approved Body 8536), dated 24 Jun 2026.
- 25 Jun 2026: Recorded Tandem AI Scribe EU MDR Class IIa (21 May 2026) and coding assistant (Feb 2026).
- 25 Jun 2026: Initial publication.
A note on categories
Ambient scribes are one category. Clinical reference tools, which help a clinician check what current guidance recommends, are a separate category and are registered separately. A scribe documents the consultation; a reference tool helps verify the plan. When comparing regulatory status, compare like with like, and be clear which category and which feature a given certificate covers. For the underlying regime distinction, see our piece on UKCA versus EU MDR Class IIa, and for the TORTUS news, our Class IIa analysis.
Frequently asked questions
Which AI scribes are certified in the UK? As of the last update, TORTUS holds UKCA Class IIa certification, and Tandem (including via Accurx Scribe) holds EU MDR Class IIa, accepted for GB use until 30 June 2028. Heidi is a self-declared Class I device with Class IIa reported in progress. Always verify current status.
What is the difference between registered and certified? Registered means listed with the MHRA, which every device must be. Certified means an independent Approved Body or notified body has assessed the device, which is required at Class IIa and above. Registration alone is not certification.
Is a Class I self-declared scribe safe to use? It can be, within its stated intended purpose and with human verification, and NHS England's AVT framework accepts at least Class I registration. But self-declaration involves less external scrutiny than Class IIa certification, so check the intended purpose and your local governance.
How do I verify a scribe's regulatory status? Check the MHRA's public register and the NHS England AVT Supplier Registry, and ask the vendor which product and feature is certified, under which regime, at which class. Do not rely on marketing headlines alone.
Why do some entries say "to confirm"? Because we could not verify that specific status from an authoritative source at the last update. It does not mean the tool lacks the status. Confirm directly with the vendor and the MHRA before relying on it.