CEP cross-reference update — sentence to append at the integrator paragraph

Internal working document

This page records the exact sentence to append to the CEP integrator paragraph and the symmetric edit to the CER. It is internal. The audit-visible artefact is the updated paragraph in R-TF-015-001 (CEP) and the updated paragraph in R-TF-015-003 (CER).

CEP target paragraph — current state

File: apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Evaluation/R-TF-015-001-Clinical-Evaluation-Plan.mdx

Section: #### Integrator integration requirements as risk controls

Lines 514-516 (current):

The device mandates a defined set of integration requirements that every integrating system MUST implement for the device to deliver the Pillar 3 clinical benefit validated in the pivotal investigations. These requirements — (i) presentation of the Top-5 prioritised differential view, (ii) display of the malignancy-prioritisation gauge, (iii) display of the referral recommendation, and (iv) display of the six binary malignancy-surfacing safety indicators — are specified in the IFU integration requirements and are tracked as risk controls in R-TF-013-002. The manufacturer does not delegate UI responsibility to the integrator: the integrator is a co-controlled risk-control agent whose obligation to implement these requirements is a precondition of the CE-marking clinical-benefit claim. Pillar 3 clinical-performance evidence in this CEP and its corresponding CER is measured on the device when integrated per these mandated specifications; the device is validated only under those conditions.

Problem with the current state: "specified in the IFU integration requirements" is vague (no section named) and "tracked as risk controls in R-TF-013-002" is vague (no entry IDs).

CEP edit — sentence to append

Append the following sentence to the end of the paragraph at line 516 (before the closing period of the paragraph's final sentence; or as a new sentence if simpler). The sentence is written as an additive clarification that does not modify the existing wording:

The mandated requirements are set out in the User Interface section of the Installation Manual (Instructions for Use); each requirement is stated with integrator-MUST language and is traced in that section to the corresponding risk-control entry or entries in R-TF-013-002.

Net effect on the paragraph:

• "specified in the IFU integration requirements" → unchanged (left as a high-level statement).
• A new sentence pins the specification to a named IFU section.
• "tracked as risk controls in R-TF-013-002" → unchanged, but now paired with a downstream guarantee that the IFU section itself cites the specific RC entries.

CER symmetric update — Step 4 of the plan

File: apps/qms/docs/legit-health-plus-version-1-1-0-0/product-verification-and-validation/clinical/Evaluation/R-TF-015-003-Clinical-Evaluation-Report.mdx

Current state (lines 474-487):

The CER's integrator paragraph already enumerates the four surfaces, but:

• It cross-references Installation manual: Endpoint specification (line 474) rather than the User Interface section for the display requirements.
• It uses the word "requires" (line 478) where the CEP uses "MUST".

Edit (a) — cross-reference target:

• Line 472 currently reads: "The presentation format and integration requirements are mandated by the manufacturer as integration requirements specified in the IFU (Installation manual: Endpoint specification); conformity of the integration is the integrator's responsibility, but the requirements themselves are set, and clinically validated, by the device." → Change the Installation manual: Endpoint specification target to Installation manual: User Interface for the display requirements. Retain an Installation manual: Endpoint specification reference where the CER discusses the mathematical derivation of the six binary indicators (the derivation truly lives in Endpoint Specification).

• Line 478 currently reads: "The IFU integration guidance (Installation manual: Endpoint specification) requires the integrator to display, as a minimum:" → Change to: "The IFU integration guidance (Installation manual: User Interface) states that the integrator MUST display, as a minimum:" — this both retargets the cross-reference and upgrades the verb from "requires" to CEP-consistent "MUST".

• Line 487 currently reads: "The device's six binary safety indicators are returned alongside the probability distribution in every API response (documented in Installation manual: Endpoint specification, § Binary Indicators). These indicators operate independently of the ICD-11 ranking and provide a safety net for high-risk presentations even if the specific malignant category is not ranked first. The IFU mandates display of these indicators." → Leave the Installation manual: Endpoint specification reference as is for this sentence, because it correctly points to the API-contract definition of the indicators. Replace "The IFU mandates display of these indicators" with "The User Interface section of the IFU mandates that the integrator MUST display all six indicators as always-visible binary states." for a more specific cross-reference.

Edit (b) — CEP/CER consistency check:

After Edit (a), the CER uses "MUST" wording and cross-references the User Interface section as the primary target, matching the CEP. The Endpoint Specification reference is retained only where the API-contract derivation lives (Binary Indicators derivation).

Commit scope

The CEP append and the CER update land in a single [minor] commit in apps/qms. The IFU delta (ifu-delta.md) lands in a separate [minor] commit in apps/eu-ifu-mdr. Keeping the two commits separate makes the CEP↔IFU cross-reference change visible at the commit level; it also keeps each app's change isolated.