Audit Deliverable Review — R-TF-015-003 CER
File reviewed: 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
Date of review: 2026-04-21
Status: ALL FIXES APPLIED — 2026-04-21.
Note on MDX imports: Import statements (e.g.
import { Education, Experience } from "@site/reusable/Taig.js") are build-time machinery and never appear in any rendered output. They are not audit-deliverable leaks.
Summary of changes applied
Category 2 — Internal data-architecture leaks (12 edits)
All 44 alphanumeric claim codes (8H5, D62, EAC, 9OD, DX7, MRT, 9D7, ZKC, DII, KOQ, NK7, LU4, R9P, LL5, SDP, 3OA, EZ1, JWQ, A1Q, 284, 3OB, 7TS, ZGP, RND, 3BD, NVT, VCT, KPQ, 1M1, UGS, IP4, WOI, V2J, WL4, LYP, 8MV, DCH, DZC, CST, 6H0, H4U, 04D, P30, LHF, 4BO) and all references to the "Performance Claims data file" / "data-file claim" / "per-data-file" were removed. Cross-references now point to the Clinical Evaluation Plan (R-TF-015-001) as the regulatory source-of-truth for acceptance criteria.
- Line 134 — "Performance Claims data file sets" → "per-study acceptance criterion is … (per the Clinical Evaluation Plan,
R-TF-015-001)" - Line 136 — "per the Performance Claims data file:" → removed
- Line 146 — "captured in the Performance Claims data file as claim 8H5 / D62" → "applied as the per-study acceptance criterion for DAO_Derivación_PH_2022 and DAO_Derivación_O_2022"
- Line 1068 — removed
data-file claim D62parenthetical - Line 1098 — removed
data-file claim EACanddata-file claim 8H5parentheticals - Line 2318 — removed both
data-file claimparentheticals - Line 2410 — acceptance-criteria derivation table: "source-of-truth Performance Claims data-file entries 8H5/D62" → "applied as the per-study acceptance criterion"
- Line 2429 — derivation table: removed
(9OD)/(DX7)/(EAC)codes, kept study references - Line 2435 — derivation table: removed
8H5/D62codes, kept study references - Line 2464 — "~148 individual performance claims" → "individual performance claims" (tilde approximation removed); "Performance Claims internal documentation" → "per-study sections of this CER and in the Clinical Evaluation Plan (
R-TF-015-001)" - Line 2470 — "per-study per-data-file" → "per-study"; claim code lists ("MRT, 9D7, ZKC...") replaced with counts only ("70 general + 24 rare + 20 malignancy")
- Line 2471 — 5RB row: claim code list ("LL5, SDP, 3OA...") removed
- Line 2472 — 3KX row: claim code list removed;
(DAO_Derivación_O_2022, claim D62)→(DAO_Derivación_O_2022);(DAO_Derivación_PH_2022, claim 8H5)→(DAO_Derivación_PH_2022) - Line 2534 — two
data-file claimparentheticals removed; "set in the Performance Claims data file" → "set in the Clinical Evaluation Plan (R-TF-015-001)"; "(data-file claim 8H5)" removed - Line 2744 — "secondary referral-adequacy (claim 8H5, +25%)" → "secondary referral-adequacy (+25%)"
- Line 2782 — "(as captured in the Performance Claims data file for each applicable study)" → "(per the Clinical Evaluation Plan,
R-TF-015-001)"
Category 3 — Internal organisational names (3 edits)
- Line 748 — "the AI Team" → "the manufacturer"
- Line 868 — "The AI Labs team creates" → "The manufacturer creates"
- Line 1991 — "the manufacturer AI Labs Group S.L. has performed" → "the manufacturer has performed"
Product-name "Plus" (5 edits — including 2 instances the original agent review missed)
- Line 1547 — "Regulatory Approach to Legacy and Plus Device Technical Documentation" → "Regulatory approach to the legacy and the current device technical documentation"
- Line 2678 — "the Plus post-market programme" → "the device's post-market programme"
- Line 2679 — (missed by original review) "the Plus PMCF activities" → "the current device's PMCF activities"
- Line 2681 — (missed by original review) "regardless of Plus denominator" → "regardless of the current device's denominator"
- Line 2685 — "the Plus post-market programme" → "the device's post-market programme"
Defensive clauses exposing BSI-response origin (2 edits)
- Line 1313 — removed "and is independent of any subsequent regulatory correspondence — Article 83 places the obligation on the manufacturer irrespective of notified-body review cycles"
- Line 2678 — removed "independently of any notified-body round"; added explicit date range ("from 23 March 2026 to 13 April 2026")
Audience-addressing phrases (3 edits)
- Line 1814 — removed "and is available for notified-body review on request"; replaced with "as part of the technical documentation"
- Line 1900 — removed "and are available to the notified body on request"
- Line 2677 — removed "and is available to the notified body on request"
Admonition styling (2 edits)
- Lines 1366–1373 —
:::info Article 61(3)admonition → introductory sentence followed by blockquote - Lines 1981–1985 —
:::info List of standardsadmonition → plain body text with URL inline
Style (1 edit)
- Line 1747 — "Annex I CV AND DECLARATIONS OF INTEREST" → "Annex I — CV and Declarations of Interest" (uppercase shouting removed)
Findings not applied
- Finding 20 (Jordi Barrachina named inline): MEDDEV 2.7/1 Rev 4 §6.4 requires named evaluators with CVs and declarations of interest. The inline mention is regulatorily appropriate; only the uppercase "AND DECLARATIONS OF INTEREST" was fixed.
- Finding 25 (mixed honorifics in skills table): Minor style polish; not a regulatory risk. Deferred.
Verification
Post-fix grep confirms zero matches for: Plus, Performance Claims data file, data-file claim, AI Labs, AI Team, notified body on request, notified-body review on request, independently of any, independent of any subsequent, :::info, per-data-file. All 44 alphanumeric claim codes cleared.