Dr Kola Tytler (MBBS MBA MRCGP) | 15 July 2026 | 8 min read
Heidi's own published NHS compliance material states that the company is progressing what Class II certification would look like for its product, alongside its current MHRA Class I registration for summarisation functionality. Pursuing certification and holding it are not the same thing, and the distinction matters more now that two competitors, Tandem and TORTUS, have each already secured independent Class IIa certification.
What Class I currently means for Heidi
Class I is a manufacturer self-declaration. Heidi registers its intended purpose with the MHRA, maintains technical and quality documentation, and does not require assessment by an external Approved Body for standard Class I software. The company states its current functionality does not autonomously generate diagnoses, management plans or clinical referrals, which is consistent with a Class I intended purpose focused on administrative summarisation with mandatory clinician review.
What Class IIa changes
Moving to Class IIa introduces independent assessment by a UK Approved Body or, under the EU route, a notified body. That means external review of the manufacturer's quality management system and technical documentation, formal clinical evaluation requirements, documented risk management processes, post-market surveillance obligations, and closer scrutiny of how software changes and new releases are handled once certified. It is a materially higher bar than self-declaration, and it is audited on an ongoing basis rather than assessed once.
Why an ambient scribe might need to sit above Class I
Basic verbatim transcription may not necessarily require anything beyond Class I. Generative summarisation, however, is a different functional claim: it is the software, not the clinician, that decides what to include, how to phrase it and what to leave out, and that draft note then feeds directly into decisions about the patient's ongoing care. NHS England's own guidance on AI-enabled ambient scribing products identifies generative summarisation as functionality likely to meet the definition of a medical device, which is the reasoning Tandem and TORTUS have each cited in explaining their own move to Class IIa. Intended purpose, not vendor marketing category, determines the correct classification.
Why Heidi may be moving towards Class IIa now
Several reasonable, non-exclusive explanations are worth setting out rather than treating any single one as definitive: regional and enterprise procurement processes increasingly expect independent regulatory assurance rather than self-declaration; expansion beyond simple note-taking into coding or workflow functionality would likely require it regardless; competitive parity with Tandem and TORTUS, both of which now lead on this point in NHS sales conversations, is a plausible commercial driver; and NHS governance and clinical safety teams are becoming more literate about the difference between registration and certification, which increases the practical value of holding the latter.
What Class IIa would, and would not, mean for Heidi
If achieved, Class IIa would give Heidi independently audited evidence behind its quality and risk management processes, remove a point of friction in enterprise procurement conversations, and put more discipline around how future product changes are released. It would not prove Heidi generates the most accurate notes in the category, would not remove the need for clinician review of every output, would not automatically extend to every feature Heidi offers (certification scope is specific to a defined intended purpose), and would not by itself demonstrate cost-effectiveness or substitute for the local DCB0160 work every deploying trust still has to complete.
Questions worth asking once certification is confirmed
NHS buyers evaluating any Class IIa claim, from Heidi or any other supplier, should ask which legal entity holds the certificate, which product version and feature set it covers, whether the regime is UKCA or EU MDR, which Approved Body or notified body issued it, what the certified intended purpose actually states, whether the scope includes documentation only or extends to coding and decision support, in which jurisdictions the certificate is valid, and what human oversight requirements the certificate specifies. A headline announcement rarely answers all of these on its own.
Conclusion
Independent Class IIa certification, if and when Heidi achieves it, would be meaningful assurance and worth taking seriously. It is not, on its own, a general ranking system for which ambient scribe is best. The certificate and its stated intended purpose will tell buyers considerably more than the headline.