Dr Kola Tytler (MBBS MBA MRCGP) | 15 July 2026 | 8 min read
Clinicians and NHS buyers are now regularly encountering Class I and Class IIa claims from AI scribe suppliers. Tandem holds EU MDR Class IIa certification for its AI Scribe and Coding Assistant. TORTUS holds UKCA Class IIa certification, assessed by UK Approved Body Scarlet. Heidi has said it is progressing towards Class IIa but had not confirmed certification at the time of writing. What can a reader legitimately infer from these milestones, and what can they not?
What Class IIa genuinely provides
Independent conformity assessment by an external body, rather than manufacturer self-declaration. Formal review of technical documentation and the manufacturer's quality management system. A defined, certified intended purpose. Documented risk management evidence. Clinical evaluation evidence specific to the certified use. Post-market surveillance obligations that continue after the certificate is issued. And, overall, meaningfully greater scrutiny than Class I self-declaration, which relies on the manufacturer's own assessment.
Why that is genuinely meaningful
The supplier can no longer rely solely on its own declaration of safety and performance. Product development processes become auditable by an external party. Risks must be systematically identified and controlled under a documented framework rather than addressed informally. Software changes have to happen within a regulated quality system, which affects how quickly and how carefully new features can ship. And NHS procurement and clinical safety teams get a clearer, externally validated regulatory foundation to build local governance on top of.
What Class IIa does not prove
It is worth being explicit about the limits, because vendor marketing rarely is. Class IIa certification does not prove the highest transcription accuracy in the category, does not prove the best note-writing style for a given specialty, does not prove the shortest documentation time, does not prove the best EPR integration, does not prove the greatest clinician satisfaction, does not prove the lowest cost, does not prove the best implementation and support team, does not prove strong performance in every specialty equally, does not prove the absence of errors, and does not prove superiority over every Class I product in the market.
Why certifications cannot be compared by class label alone
UKCA and EU MDR are different regulatory routes, assessed by different types of body under different rules, even though both use the IIa label. Certificates cover a specific, defined intended purpose, not the entire product; one certificate might cover documentation only, another might extend to coding or decision support. The specific product version and the exact legal manufacturer named on the certificate matter, as does the geographic scope in which it is valid. Current transitional arrangements mean a valid CE mark remains accepted for use in Great Britain until 30 June 2028, which is worth factoring in when a supplier's certification route differs from a competitor's.
A procurement checklist worth using
Before treating any Class IIa claim as settled, ask for the exact legal manufacturer named on the certificate, the regulatory regime (UKCA or EU MDR), the specific device class, the certificate number, the certifying body, the certified intended purpose in full, the specific product version covered, the human oversight requirements the certificate specifies, the population and setting the underlying clinical evidence covers, the EPR integrations actually supported (as distinct from claimed), the error-monitoring process in practice, the post-market surveillance arrangements, contractual liability terms, the implementation support actually offered, and the total cost across licensing, integration and training.
A fair conclusion
Class IIa certification should be treated as meaningful evidence of independently assessed regulatory maturity, and buyers are right to weight it in a tender. It should not be treated as proof that one AI scribe is universally better than another. The certificate and its stated intended purpose, read in full, will tell a buyer considerably more than which company announced its Class IIa status first.