Two AI documentation companies have each announced a first Class IIa certification, and both claims are accurate, because they were certified under different regulatory regimes. TORTUS is the first ambient voice technology certified under the UK's own UKCA regime, at Class IIa, by a UK Approved Body. Tandem is the first medical scribe certified Class IIa under the EU's Medical Device Regulation, CE marked, by an EU notified body. Same class name, different regulator, different route. Most coverage is conflating the two. Here is how to separate them.
Key takeaways
- TORTUS is the first AVT certified UKCA Class IIa, under the UK regime, by Approved Body Scarlet.
- Tandem is the first medical scribe certified EU MDR Class IIa, CE marked, by an EU notified body.
- Both firsts are true because the regime and the certifying route differ.
- For GB use, a UKCA mark is the native route; a valid CE mark is accepted until 30 June 2028.
- Read the certificate scope: which product, which feature, which regime, and which class.
What did TORTUS achieve?
TORTUS was certified as a UKCA Class IIa medical device by Scarlet (UK Approved Body 8536) on 24 June 2026, the first ambient voice technology to reach this classification under the UK Conformity Assessed regime. UKCA is the UK's own post-Brexit marking, assessed by a UK Approved Body, and it is the native route for placing a higher-risk medical device on the market in Great Britain.
What did Tandem achieve?
Tandem took the EU route. Its Coding Assistant was certified as Class IIa under EU MDR in February 2026, which Tandem describes as the first in Europe in its category, and its AI Medical Scribe reached EU MDR Class IIa on 21 May 2026, following independent notified body assessment. Tandem's products are CE marked under EU MDR and the company also holds MHRA registration in Great Britain. So Tandem's first is a Class IIa certification under EU MDR, a different regime from UKCA.
Why are both "firsts" true?
Because a first is only a first within a defined frame, and these two frames differ on every axis that matters:
- Regime: TORTUS is certified under the UK's UKCA regime; Tandem under the EU's MDR (CE marking).
- Certifying body: TORTUS was assessed by a UK Approved Body (Scarlet); Tandem by an EU notified body.
- Category framing: TORTUS claims the first for ambient voice technology; Tandem claims the first medical scribe, and separately the first coding assistant in its category, under MDR.
None of these claims contradicts the others. They are firsts in different races.
What does UKCA versus CE marking mean for NHS procurement?
For clinical use in the NHS, a device must be registered with the MHRA and carry the appropriate marking. Post-Brexit, the UK's native marking is UKCA, but the transition arrangements matter: NHS England guidance confirms that a valid CE mark is equally acceptable for clinical use until 30 June 2028. In practice, that means a CE-marked EU MDR device such as Tandem can be procured and used in Great Britain during the transition, provided it is also MHRA registered, while a UKCA-marked device such as TORTUS holds the GB-native certification. Both routes are legitimate; the difference is which regime did the assessing and how long a CE mark remains accepted.
Why should buyers read the certificate scope, not the headline?
Because "Class IIa certified" does not tell you what was certified. A certificate applies to a specific product and a specific intended purpose. A company may have one feature certified at Class IIa and others that are not, or may hold a certification under one regime but not the other. The headline is a marketing summary; the certificate is the fact. Buyers should look at which product and feature the certificate covers, which regime issued it, which class it is, and the certified intended purpose.
How to ask a vendor which regime and which feature is certified
A short set of questions cuts through the ambiguity:
- Under which regime is this certified: UKCA or EU MDR?
- Which specific product and feature does the certificate cover, and what is the certified intended purpose?
- What class is it, and who was the Approved Body or notified body?
- Is the device MHRA registered for use in Great Britain?
- If CE marked, what is your plan for UKCA ahead of the June 2028 deadline?
For a live view of where each tool sits, see our AI scribe regulatory status tracker, and for the TORTUS announcement in detail, our piece on its UKCA Class IIa certification. For more on Tandem and Accurx Scribe, see our analysis of the NHS ambient scribing category.
Frequently asked questions
Is TORTUS or Tandem the "first" Class IIa scribe? Both hold a legitimate first, under different regimes. TORTUS is the first ambient voice technology certified UKCA Class IIa; Tandem is the first medical scribe certified EU MDR Class IIa. Neither claim is wrong.
What is the difference between UKCA and CE marking? UKCA is the UK's own post-Brexit marking, assessed by a UK Approved Body. CE marking is the EU route under MDR, assessed by an EU notified body. For GB clinical use, a valid CE mark is accepted until 30 June 2028.
Can a CE-marked scribe be used in the NHS? Yes, during the transition. NHS England guidance accepts a valid CE mark for clinical use until 30 June 2028, provided the device is also MHRA registered.
Why does the certificate scope matter? Because "Class IIa certified" does not say what was certified. A certificate covers a specific product, feature and intended purpose under a specific regime. Always check the scope rather than the headline.
Which is better, UKCA or EU MDR certification? Neither is inherently better. They are different regimes for different markets. What matters for a GB buyer is that the device is appropriately certified and MHRA registered, and that the certified scope matches your intended use.