IFU delta — integrator-MUST inserts for the four mandated surfaces

Internal working document

This page is a red-lined-style description of the surgical inserts to apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx. It is not shipped to BSI and is not part of the audit-visible technical file. The audit-visible artefact is the updated IFU page itself.

Intent

Close the four gaps recorded in ifu-coverage-audit.md without altering the IFU's existing structure (per user decision Q2 — "most of this is already in the IFU, keep the current structure"). Every insert is additive. No sub-section is removed, renamed, or reordered.

All inserts use integrator-MUST language, state the visibility / ordering / distinguishability requirements on which Pillar-3 clinical-performance claims depend, and cite the relevant R-TF-013-002 risk-control entries from the surface-to-RC map in the coverage audit.

Insert 1 — Preface to the "Report" section

Target location: user-interface.mdx, immediately after the ## Report heading at line 102 and before ### Full Diagnostic Report at line 104.

New content:

The sub-sections below define, in addition to presentation guidance, the UI elements whose integrator-MUST implementation is a precondition of the clinical performance validated in the device's Clinical Evaluation Report (R-TF-015-003). Four surfaces carry mandatory presentation, visibility, and ordering requirements: the Top-5 prioritised differential view, the malignancy-prioritisation gauge, the referral recommendation, and the six binary malignancy-surfacing safety indicators. Each mandated requirement is traced to the corresponding risk-control entry or entries in the Risk Management Record (R-TF-013-002). The remaining elements below — image quality, entropy, severity assessment, metadata, quick insights — are recommended integration features whose adoption is at the integrator's discretion.

Rationale: this preface gives the CEP and CER a concrete, named paragraph to cross-reference ("the User Interface section of the Installation Manual"), and distinguishes mandatory UI surfaces from recommended ones so an auditor can navigate the page without ambiguity.

Insert 2 — Top-5 Predictions (Surface 1)

Target location: user-interface.mdx, after the <Top5 /> render at line 185 and before the "Location in the Device Output" sub-heading at line 187.

New content:

The integrator MUST render the Top-5 prioritised differential view in descending-probability ranked order, as a single visually cohesive block, with each ICD-11 candidate clearly labelled. Ranked order is a precondition of the Pillar 3 clinical-performance claim evaluated in R-TF-015-003: the Top-1, Top-3, and Top-5 accuracy metrics reported in the pivotal investigations all assume the clinician sees the candidates in the order produced by the device. The risk controls for misinterpretation of the ranked output are recorded in R-TF-013-002 (entries R-BDR "Misinterpretation of data returned by the device" and R-A96 "Incompatibility in classification systems").

Insert 3 — Referral (Surface 3)

Target location: user-interface.mdx, after the <Referral /> render at line 251 and before the "Thresholds" sub-heading at line 253.

New content:

The integrator MUST surface the referral recommendation alongside the Top-5 prioritised differential view, not behind additional interaction (for example, behind an expand control, a secondary tab, or a separate screen). The referral value is a clinical-performance output on which the Pillar 3 care-pathway claims in R-TF-015-003 (benefit 3KX, sub-criteria waiting times, referral adequacy, and remote care) depend. The numeric bands shown below are minimum triage thresholds; the integrator MAY apply stricter local thresholds but MUST NOT suppress the referral field from the rendered report. The risk controls for misinterpretation of the referral output are recorded in R-TF-013-002 (entries R-BDR "Misinterpretation of data returned by the device" and R-75H "The medical device outputs incorrect clinical information").

Insert 4 — Malignancy (Surface 2)

Target location: user-interface.mdx, after the <Malignancy /> render at line 290 and before the "Thresholds" sub-heading at line 292.

New content:

The integrator MUST display the malignancy-prioritisation value as a visually distinguishable gauge (for example, a coloured bar, dial, or badge) immediately visible to the healthcare professional without additional clicks or tabs, not as plain decorative text. The gauge MUST re-surface malignancy risk regardless of whether a malignant ICD-11 category occupies the top rank in the Top-5 view: this is an independent safety-signal surface, not a derivative of the Top-5 ordering. The risk controls for mis-rendering the malignancy gauge are recorded in R-TF-013-002 (entries R-HBD "Misrepresentation of magnitude returned by the device", R-BDR "Misinterpretation of data returned by the device", and R-DAG "The medical device outputs a wrong result").

Insert 5 — New sub-section: "Malignancy-surfacing safety indicators" (Surface 4)

Target location: user-interface.mdx, a new #### Malignancy-surfacing safety indicators sub-section inserted after the "Malignancy" sub-section (which ends at line 323) and before the "Severity assessment" sub-section (which starts at line 325).

New content:

Malignancy-surfacing safety indicators

The device returns six binary malignancy-surfacing safety indicators in every API response. Their definitions, their clinical meaning, and their derivation from the ICD-11 probability distribution are documented in the "Binary Indicators" section of Endpoint specification (sibling page in the Installation Manual; the IFU file uses a relative link ./endpoint-specification that resolves inside the eu-ifu-mdr app). The indicators are: malignant, pre-malignant, associated with malignancy, pigmented lesion, urgent referral (within 48 hours), and high-priority referral (within 2 weeks).

The integrator MUST surface all six indicators in the user interface as always-visible binary states. They MUST NOT be hidden behind an expansion control, a secondary tab, or a collapsed region that requires user interaction to reveal. The indicators provide a safety net independent of the Top-5 ICD-11 ranking: they flag the presence of any high-risk category anywhere in the probability distribution, including cases where the malignant category is not ranked first.

These indicators are a precondition of the clinical-benefit claims under benefit 7GH, sub-criterion (c) malignant lesions, documented in the Clinical Evaluation Report (R-TF-015-003). The risk controls for failing to surface the indicators in the user interface are recorded in R-TF-013-002 (entries R-BDR "Misinterpretation of data returned by the device", R-HBD "Misrepresentation of magnitude returned by the device", and R-SKK covering patient-visible erroneous-result pathways).

Inserts not required

• Instructions sub-section (lines 38-100) — unrelated to the four mandated surfaces; left unchanged.
• Image Quality, Entropy, Severity assessment, Metadata, Quick Insights sub-sections — these are recommended integration features, not mandated surfaces; covered by the Insert 1 preface statement ("remaining elements below … are recommended integration features whose adoption is at the integrator's discretion"). No per-sub-section edits.
• Label sub-section (lines 468-513) — already uses integrator-MUST language under GSPR 23.2; the existing content is sufficient.

Style-rule cross-check

• No product name or company name referenced in any insert.
• No internal file path, BSI ticket ID, or task-folder reference in any insert.
• No JSX component name appears in rendered prose (the inserts reference surfaces by their regulatory names: "Top-5 prioritised differential view", "malignancy-prioritisation gauge", "referral recommendation", "binary malignancy-surfacing safety indicators").
• Cross-references use audit-visible IDs only (R-TF-015-003, R-TF-013-002, R-BDR etc.).
• < and > characters are not introduced; MUST, MUST NOT, and MAY follow RFC-2119 convention already used in the IFU's Label section.

Commit scope

All five inserts land in a single [minor] commit touching only apps/eu-ifu-mdr/versioned_docs/version-1.1.0.0/installation-manual/user-interface.mdx. The CEP and CER edits (Steps 3 and 4 of the plan) land in a separate [minor] commit in apps/qms.