Article 2(1) — Definition, and where our functions sit
A function is a device if its intended purpose includes diagnosis, prevention, monitoring, prediction, prognosis or treatment.
The dictation and note-drafting path transcribes what was said so a clinician can edit it. It does not interpret.
The clinical reasoning path is the one that matters. It surfaces proposals with their evidence, and the framing is enforced at the output boundary: no clinical-claim language, and no proposal without a cited chain. A proposal a clinician must adopt before it means anything is information for a decision, not a decision — but this is the boundary, and it is a boundary of intended purpose rather than of implementation.
Annex VIII, Rule 11 — Classification if it is a device
Software intended to provide information used to take decisions for diagnosis or therapy is Class IIa, rising to IIb or III where the decision could cause serious deterioration or death. MDCG 2019-11 is the guidance that reads Rule 11 onto software.
The consequence is worth stating plainly: under Rule 11, a clinical decision-support function in healthcare is rarely Class I. If a function crosses the definition, it arrives at IIa or above, and with it a notified body.
Article 10 — Manufacturer obligations
A QMS, technical documentation, conformity assessment, CE marking, a person responsible for regulatory compliance, and registration in EUDAMED are the obligations that follow from placing a device on the market.
Article 5(5) — The health institution exemption
A health institution that manufactures and uses a device in-house, and does not transfer it to another legal entity, is exempt from most of the Regulation provided it meets the conditions in 5(5) — including a justification that no equivalent device on the market meets the need.
If you configure the platform to produce something with a medical purpose for your own patients, this is the route that would apply to you, and the conditions are yours to meet. The platform's contribution is that what it did is reconstructable: the proposal, its evidence chain, the versions involved, and the clinician who accepted it.
Annex I — General safety and performance requirements
Chapter I, 1 and 3 — safe by design, risk of use. The clinician remains the decision-maker; the system proposes and records what was proposed.
Chapter II, 17 — electronic programmable systems. Repeatability and reliability: responses are constrained to a structured form with stable prompts, and a model may reach only a curated, typed tool catalogue. A missing model is an explicit failure rather than a silent substitution.
17.4 — IT security. The same measures the other two regulations ask for.
Chapter III, 23 — information supplied with the device. Instructions for use, intended purpose and limitations.
Articles 61 and 62, Annex XIV — Clinical evaluation
Clinical evidence appropriate to the class and the claim, planned and documented. Our benchmarking methodology is published and the results are ours to state; that is not a clinical evaluation, and calling it one would be the error this page exists to avoid.
Articles 83–86 — Post-market surveillance
A surveillance system, a PMS plan, and periodic reporting proportionate to class. The platform supplies the field data: every proposal, its chain, its versions, and whether a clinician accepted or rejected it.
Article 87 — Vigilance
Reporting serious incidents and field safety corrective actions runs to a timetable measured in days. It is a process obligation with a clock, and the platform's part is detection and an immutable record.
Deciding that an event is reportable, and reporting it, belongs to whoever holds the device obligations.
What would change the answer
Three things would move a function inside the definition: claiming a diagnostic, prognostic or treatment purpose for it; removing the clinician from between the proposal and the record; or presenting a proposal as a conclusion. The first is a marketing decision, the second an architectural one, and the third a wording one — and all three are ours to avoid deliberately rather than by accident.