Narrowed-claim language — autoimmune dermatoses and genodermatoses

Scope. Replacement / additive prose for the output-interpretation warning that qualifies the device's CLAIM for autoimmune and genodermatoses sub-categories. The indication remains broad; the claim is qualified by a warning rendered in the Device Output Warnings section. Internal scratch-pad; no audit-visible document references this file.

Placement decision (ratified with Taig). The warning goes in WarningsDeviceOutput (existing reusable snippet rendered in Device Description, STED and IFU) — not in IntendedPurpose or IntendedMedicalIndication, because the indication is not being narrowed. The wording is an output-interpretation warning, which matches the existing content model of WarningsDeviceOutput.

Translation parity. Per packages/reusable/CLAUDE.md, every new key in en.json must be added to es.json and pt.json in the same commit, otherwise runtime falls back silently to English. The draft below includes all three locales.

---

D1 — New paragraph for WarningsDeviceOutput.mdx

Rendering change in the reusable component

Current component body (packages/reusable/snippets/WarningsDeviceOutput.mdx lines 13–45) ends with a single paragraph using the clinicalDecisionSupport key:

<p>{tc.clinicalDecisionSupport}</p>

Additive change. Add a new paragraph immediately below the clinicalDecisionSupport paragraph, rendered from a new translation key warningsDeviceOutput.lowPrevalenceCategories:

<p>{tc.clinicalDecisionSupport}</p>

<p dangerouslySetInnerHTML={{ __html: tc.lowPrevalenceCategories }} />

Translation-key additions

Add to translatedComponents.js (WarningsDeviceOutputContent, after clinicalDecisionSupport):

    lowPrevalenceCategories: getTranslatedContent(
      "warningsDeviceOutput.lowPrevalenceCategories",
      locale
    ),

Add to packages/reusable/translations/en.json:

  "warningsDeviceOutput.lowPrevalenceCategories": {
    "message": "<strong>Low-prevalence sub-indication categories.</strong> For autoimmune dermatoses and genodermatoses, the device provides a probability ranking within its broader ICD-11 output distribution. These outputs are to be interpreted as supporting information within the healthcare professional's differential-diagnosis workup. Final diagnosis for these categories is a healthcare-professional determination based on clinical evaluation and histopathological, serological or genetic examination as per the current standard of care; the device's probability ranking is supporting information only.",
    "description": "Output-interpretation warning for autoimmune dermatoses and genodermatoses sub-indication categories"
  },

Add to packages/reusable/translations/es.json:

  "warningsDeviceOutput.lowPrevalenceCategories": {
    "message": "<strong>Subcategorías de indicación de baja prevalencia.</strong> Para las dermatosis autoinmunes y las genodermatosis, el dispositivo proporciona una clasificación probabilística dentro de su distribución amplia de categorías CIE-11. Estas salidas deben interpretarse como información de apoyo dentro del proceso de diagnóstico diferencial del profesional sanitario. El diagnóstico final de estas categorías es una determinación del profesional sanitario basada en la evaluación clínica y en el examen histopatológico, serológico o genético conforme al estado del arte actual; la clasificación probabilística del dispositivo es únicamente información de apoyo.",
    "description": "Output-interpretation warning for autoimmune dermatoses and genodermatoses sub-indication categories"
  },

Add to packages/reusable/translations/pt.json:

  "warningsDeviceOutput.lowPrevalenceCategories": {
    "message": "<strong>Subcategorias de indicação de baixa prevalência.</strong> Para as dermatoses autoimunes e as genodermatoses, o dispositivo fornece uma classificação probabilística dentro da sua distribuição ampla de categorias CID-11. Estes resultados devem ser interpretados como informação de suporte dentro do processo de diagnóstico diferencial do profissional de saúde. O diagnóstico final destas categorias é uma determinação do profissional de saúde baseada na avaliação clínica e no exame histopatológico, serológico ou genético de acordo com o estado da arte atual; a classificação probabilística do dispositivo é apenas informação de suporte.",
    "description": "Output-interpretation warning for autoimmune dermatoses and genodermatoses sub-indication categories"
  },

Canonical render sites (inherited from WarningsDeviceOutput inventory)

Per packages/reusable/CLAUDE.md §Snippet inventory, WarningsDeviceOutput renders in:

• Device Description record (r-tf-description-and-specification.mdx)
• STED (r-tf-sted.mdx)

It does NOT currently render in the IFU or the CER/CEP directly. See D2 below for the IFU fallback.

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D2 — IFU Precautions / Limitations — verification and fallback

Verification step

Grep apps/eu-ifu-mdr/ for <WarningsDeviceOutput and for the existing Precautions section. Two cases:

1. If the IFU already renders <WarningsDeviceOutput /> — D1 propagates automatically. Visually verify via npm run start --filter=eu-ifu-mdr that the new paragraph appears in the rendered IFU page and the PDF export.
2. If the IFU does NOT render <WarningsDeviceOutput /> — add the paragraph inline in the IFU Precautions / Limitations section using the same sentence as the en.json message (stripped of <strong> tags if the MDX style prefers bold markdown), and cross-reference the Device Description section that does render the reusable.

Fallback inline text for the IFU (if needed)

If the IFU Precautions section carries an inline paragraph rather than the reusable, insert the following paragraph at the matching level:

Low-prevalence sub-indication categories. For autoimmune dermatoses and genodermatoses, the device provides a probability ranking within its broader ICD-11 output distribution. These outputs are to be interpreted as supporting information within the healthcare professional's differential-diagnosis workup. Final diagnosis for these categories is a healthcare-professional determination based on clinical evaluation and histopathological, serological or genetic examination as per the current standard of care; the device's probability ranking is supporting information only.

Mapping to the CER's "Consolidated limitations of the device"

The CER B2 rewrite (four-test-rewrite.md §B2) already references this IFU warning: "For these two sub-categories specifically, the device's output is to be interpreted as supporting information within the healthcare professional's differential-diagnosis workup and not as a standalone diagnostic determination (see section Device outputs and the IFU Precautions)." The IFU paragraph above is the canonical destination of that cross-reference.

---

D3 — Performance Claims data check

Check to perform

Read packages/ui/src/components/PerformanceClaimsAndClinicalBenefits/data/ and locate the 7GH Diagnostic Accuracy benefit definition. Determine whether the data model has:

• A subIndicationQualifier / claimScope / warnings field at the benefit level or at the sub-criterion level.
• A mechanism to render a per-sub-indication qualifier in the CER/STED/IFU rendering of the benefit.

Expected outcome

Most likely the data model does not have a per-sub-indication qualifier field (the benefit data is structured around acceptance criteria, not narrative qualifications). In that case:

• No edit to the data file is required.
• The warning propagates via D1 (WarningsDeviceOutput) and D2 (IFU inline fallback if needed).
• Record this finding in the task-3b5 kanban / memo footer: "7GH benefit data does not carry per-sub-indication narrative fields; the claim qualification is rendered via the Device Output Warnings reusable. No data-model change required."

If a per-sub-indication field exists

If the data model DOES carry a per-sub-indication field that is rendered in audit-visible documents, add an entry for 7GH sub-criterion (a) flagging autoimmune and genodermatoses, with the same sentence as the en.json message. Coordinate with the PerformanceClaimsAndClinicalBenefits CLAUDE.md two-tier type pattern (ComponentData vs. Component with computed fields; never store computed fields in the data file).

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E — Risk Management File (R-TF-013-002) — no-change assessment

The assessment

Per the task-3b5 plan (§E), the cross-reference to the Risk Management File is to be added only if risks are affected by the narrowed-claim framing. The narrowed-claim sentence is a user-instruction-level warning added to the Device Output Warnings section; it does not introduce a new residual risk — the device's residual risks for misdiagnosis are already captured in existing AI-RISK entries in R-TF-013-002 and in R-TF-028-011 (for example R-75H & R-DAG "Incorrect clinical output / Misdiagnosis" — PMCF Plan line 81).

The decision

No new RMF risk entry is required. The existing risk-controls for R-75H / R-DAG and the image-quality risks R-AGQ / R-5L4 already cover the hazard modelled by misinterpretation of the device's probability ranking; the narrowed-claim warning reinforces those controls via the IFU / Device Output Warnings route without creating a new residual risk.

The record

Record this assessment in the task-3b5 memo footer as follows:

RMF impact assessment (2026-04-21, narrowed-claim language for autoimmune and genodermatoses sub-categories): no new residual risk introduced. The existing AI-RISK entries (R-75H, R-DAG, R-AGQ, R-5L4 per R-TF-013-002 and R-TF-028-011) already cover the misinterpretation hazard; the narrowed-claim warning in WarningsDeviceOutput reinforces those risk-controls via the IFU / Device Description route. No edit to R-TF-013-002 required. If a subsequent reviewer (BSI, internal risk-management-expert) flags a new residual risk, escalate via @agent risk-management-expert before editing the RMF.

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Review notes for this file

• Audit-deliverable-reviewer concern: the warning text itself is audit-visible (it renders in the Device Description, STED, and IFU). Check that it uses regulatory-level language only (HCP, ICD-11, differential-diagnosis workup, histopathological / serological / genetic examination, current standard of care) and that it does not leak engineering internals (no packages/, no translations/, no React or MDX references in the rendered sentence — these appear only in this scratch-pad file, not in the propagated sentence).
• BSI clinical-auditor concern: check that the wording keeps the indication broad (no "out of scope" or "excluded" language); check that the HCP is named as the decision-maker ("final diagnosis ... relies on clinical evaluation ... and not on the device's probability ranking alone") — this aligns with IEC 62366-1 / MEDDEV 2.7/1 wording on HCP responsibility; check that the warning does not accidentally narrow GSPR 17 compliance or re-open a benefit-risk determination.
• Celine clinical-consultant concern: check integrator-responsibility / HCP-responsibility language — the warning states the device PROVIDES a probability ranking as supporting information, and the HCP makes the final diagnosis (correct framing per the pillar-mapping framework — the device does not delegate determinations it cannot make, but also does not claim determinations that are the HCP's).