Background

The regulatory classification of AI medical scribes under the European Medical Device Regulation (EU MDR, Regulation 2017/745) has been a source of uncertainty across European healthcare markets. Manufacturers have reached different conclusions about whether AI scribes qualify as medical devices and, if so, at what risk class. Healthcare organisations have been left to make their own interpretations, with significant variation in procurement requirements, information governance frameworks, and deployment decisions as a result.

In early 2026, Sweden's Medical Products Agency initiated a formal market surveillance effort specifically targeting this product category. The findings from that effort at Tandem Health provide one of the most authoritative regulatory guidance to date on how AI scribes should be classified under EU MDR.

This article summarises the key findings from Sweden's Medical Products Agency's preliminary inspection report of Tandem Health AB. We're publishing these findings with Sweden's Medical Products Agency's explicit confirmation that we're permitted to do so. The definitive report is expected later in 2026.

The inspection

The inspection was conducted as part of Sweden's Medical Products Agency's AI Ambient Scribe Focus Initiative, a proactive, announced market surveillance initiative designed to assess whether AI scribes operating in Swedish healthcare are correctly qualified and classified under EU MDR, and whether they meet applicable regulatory requirements.

The scope covered product qualification and classification, intended purpose and actual use, claims in marketing materials and instructions for use, relevant parts of the technical file, product architecture and functional mechanisms, a live demonstration, and a functional product test conducted by Sweden's Medical Products Agency using simulated clinical conversations.

Findings overview

The preliminary report identified one nonconformity (NC1) and four observations (O1–O4). The single nonconformity concerned product classification, specifically that Tandem AI Medical Scribe had been classified as Class I under EU MDR Annex VIII Rule 11, which Sweden's Medical Products Agency assessed was not compatible with the product's intended purpose, actual functionality, and inherent risks.

The nonconformity was categorised as minor rather than major, on the basis that the product was already CE marked and that Tandem had already reviewed the classification and was actively preparing for Class IIa certification at the time of inspection.

The four observations related to intended purpose documentation, product distinction in user-facing materials, CE mark usage, and declaration of conformity content. None constituted formal nonconformities.

The classification question: is an AI scribe a Class I or Class IIa medical device?

The central regulatory question addressed by the inspection was whether an AI scribe, software that listens to clinical consultations, generates draft clinical notes, and writes into the patient record, should be classified as Class I or Class IIa under EU MDR Annex VIII Rule 11.

Sweden's Medical Products Agency's position is that the completed documentation generated by the scribe is used as the basis for decisions in the continued care process, not just the current visit. That is what brings it under the higher classification.

Sweden's Medical Products Agency's conclusion, translated directly from the report:

"Sweden's Medical Products Agency assesses that the above supports the conclusion that the product meets the criteria for a classification of at minimum Class IIa, and that a classification of Tandem AI Medical Scribe as Class I is not compatible with EU MDR."

The regulatory framework: EU MDR Annex VIII Rule 11 and MDCG 2019-11

The classification determination is anchored in two documents: EU MDR Annex VIII Rule 11 and MDCG 2019-11 rev. 1, the European Commission's guidance on software qualification and classification, approved by the Medical Device Coordination Group.

MDCG 2019-11 rev.1 divides Rule 11 into three sub-rules:

Sub-rule 11a applies to software intended to provide information used to take decisions with diagnostic or therapeutic purposes. The guidance is explicit on its scope:

"The wording 'intended to provide information which is used to take decisions with diagnosis or therapeutic purposes' describes the 'mode of action' which is characteristic of all MDSW. Therefore, this sub-rule is generally applicable to all MDSW (excluding those MDSW that have no medical purpose)."

Sub-rule 11b applies to software intended to monitor physiological processes or parameters.

Sub-rule 11c, the only pathway to Class I, applies to all other uses: software whose output does not influence clinical decisions and does not monitor physiological processes.

The implication is direct: medical device software that provides information used in healthcare decisions does not, as a starting point, belong to Class I. It belongs at minimum to Class IIa.

Why the AI scribe falls under sub-rule 11a

Sweden's Medical Products Agency's inspection and functional testing identified four characteristics of the AI scribe that informed the classification determination.

The product's mode of action is to provide information, transcripts, summaries, draft clinical notes, used in the continued care process. Even where no clinical decisions are made during the consultation itself, the completed documentation serves as the basis for decisions in ongoing clinical management.

The product contains functions that include inference and structuring of clinical information based on consultation content, not mere transcription, but active organisation and interpretation of clinical material.

Tandem's own risk management file identified among other things delayed diagnosis due to misinterpreted information as a risk scenario, which by definition means the software's output is capable of influencing clinical decisions.

Classification is not determined by whether the clinician makes decisions before or after documentation is finalised. It is determined by whether the software's output is used in the continued care process.

The classification conclusion

Class IIa is the floor, not the ceiling. Higher classifications (IIb or III) could apply if for example incorrect product output were reasonably likely to cause death, irreversible deterioration, serious deterioration, or surgical intervention. Sweden's Medical Products Agency assessed the product at Class IIa, acknowledging that the clinical consequence of incorrect output, while meaningful, did not reach the threshold for higher classification.

EU MDR Annex VIII Rule 11 states the framework plainly: software intended to provide information used for diagnostic or therapeutic decisions belongs to Class IIa. An AI scribe writing clinical notes into the medical record does not belong in the "all other software" category.

Resolution

Tandem Health achieved Class IIa certification for the AI Medical Scribe on 21 May 2026, following independent notified body assessment. Sweden's Medical Products Agency confirmed the resolution in the report:

"Sweden's Medical Products Agency notes that as of 21 May 2026, having been informed that Tandem AI Medical Scribe is now CE marked as a Class IIa medical device under MDR, the nonconformity has been remedied."

What this means for the market

Sweden's Medical Products Agency's initiative covered AI scribes across the Swedish market, not only Tandem. Other manufacturers will have received their own inspection findings.

Yan Peng Zhao, Tandem's Compliance Lead, welcomes the regulatory clarity: When AI inference shapes information that can inform diagnosis and treatment, it makes sense that it falls under Rule 11a. Clarity from the competent authority benefits both manufacturers and healthcare organisations.

The regulatory logic derives directly from EU MDR and MDCG 2019-11, the same framework applicable across all EU member states. For manufacturers: Class I classification of AI medical scribes with this mode of action is not compatible with EU MDR. For healthcare organisations: the relevant question is no longer whether a vendor asserts their product is safe. It is whether the product has been independently assessed as safe and performant, which is the requirement for a Class IIa product.

A note on transparency

We're publishing these findings because the market shouldn't have to wait until the full report is published or similar for regulatory clarity that already exists.

We recognise that we're not a neutral party in this discussion. We made our own classification error along the way, and we have commercial interest in this market. Readers should keep that in mind.

That said, we believe the regulatory reasoning set out in this report is sound, that it applies across the category, and that healthcare organisations and manufacturers benefit from understanding it now. The uncertainty around AI scribe classification has placed the burden of regulatory interpretation on healthcare organisations that shouldn't have to carry it. A clear, independently derived standard removes that burden.

We welcome Sweden's Medical Products Agency's initiative and look forward to the definitive report.

Preliminary inspection report, Sweden's Medical Products Agency, Dnr: 6.6.3-2025-109474. Definitive report pending. All regulatory phrasing reviewed by Tandem's compliance and legal team.

Questions: press@tandemhealth.ai