CER coverage matrix
This page provides a verifiable mapping from every external requirement to a concrete anchor in R-TF-015-003 Clinical Evaluation Report. Three source streams are covered:
- BSI Round 1 clinical findings (items 1–7) — the non-conformities raised during the MDR technical documentation assessment.
- MDCG 2020-13 — Clinical Evaluation Assessment Report template (July 2020), sections A–K — the template the notified body uses to score a CER.
- CER Template (Mantra Systems, Edition 2) — sections 1–14 — a fully worked MDR-compliant CER outline.
The faithful markdown transcriptions of both reference documents are in mdcg-assessment/ and cer-template/.
Every anchor in the right-hand column is wrapped in backticks (e.g. `#executive-summary`) and is validated by apps/qms/scripts/check-cer-coverage.mjs, which mirrors Docusaurus's default heading slugifier. The script fails the CI build if any anchor does not resolve against a real heading in the CER — so this matrix cannot silently rot.
How to read the status column
The status column describes the structural mapping between each requirement and a CER/CEP anchor; it does not assert adequacy of the underlying content. BSI's assessment of sufficiency is a separate judgement made by the notified body.
- Addressed — a CER section exists that substantively treats the requirement. Adequacy is for BSI to determine.
- Partial — the CER contains some relevant material but the requirement is not fully articulated inside the CER; enhancement may be appropriate.
- External — the CER references an external controlled document (CEP, SotA, PMCF Plan, Usability Evaluation Report, etc.) where the requirement is addressed, and duplication inside the CER is not intended.
- N/A — the requirement is not applicable to this device under the cited legal basis (e.g. MDCG 2020-13 §J applies only when Article 61(10) is invoked, which is not the case here).
1. BSI Round 1 clinical findings
| Finding | Topic | CER anchor(s) | Status |
|---|---|---|---|
| Item 1 | CER update frequency and triggers | #date-of-the-next-clinical-evaluation | Addressed |
| Item 2a | Device description — indications, ICD-11 scope, device outputs | #device-description · #device-outputs · #scope-of-icd-11-categories · #high-risk-and-malignant-conditions | Addressed |
| Item 2b | Clinical benefits, performance & safety vs SotA; acceptance criteria derivation; safety benchmarking; tiered evidence | #clinical-benefits · #acceptance-criteria-derivation-from-state-of-the-art · #safety-benchmarking-against-state-of-the-art · #tiered-evidence-assessment-strategy · #summary-of-clinical-benefits-achievement | Addressed |
| Item 3a | Clinical data sufficiency — sample size, representativeness, coverage of indications | #justification-of-sufficiency-of-clinical-evidence · #representativeness-of-the-study-populations-demographics--skin-phototypes · #evidence-coverage-by-disease-category | Addressed |
| Item 3b | Equivalence & literature appraisal (QUADAS-2, MINORS) | #demonstration-of-equivalence · #validated-methodological-quality-appraisal · #quadas-2-diagnostic-accuracy-studies · #minors-clinical-utility-and-referral-pathway-studies · #minors-mrmc-simulated-use-studies · #minors-published-severity-validation-studies-technical-performance-evidence | Addressed |
| Item 4 | Summative usability evaluation evidence | #summative-usability-validation | External (full report: R-TF-025-007 Summative Evaluation Report, October 2025) |
| Item 5 | PMS Plan traceability — Articles 83–88, Annex III | #clinical-data-generated-from-risk-management-and-pms-activities · #post-market-clinical-follow-up-data · #pms-and-pmcf-feedback-loop | Addressed (PMS Plan: R-TF-007-001) |
| Item 6 | PMCF Plan — activity detail, sample sizes, evidence coverage for rare conditions | #necessary-measures · #pms-and-pmcf-feedback-loop | Addressed (PMCF Plan: R-TF-007-002) |
| Item 7 | Risk management — AI vs patient-safety integration, multi-barrier architecture | #risk-management-and-residual-risks-acceptability · #risk-architecture | Addressed (AI risk register: R-TF-028-011; patient-safety risk register: R-TF-013-002) |
2. MDCG 2020-13 (CEAR) sections
Reference: MDCG 2020-13 section transcriptions.
| Section | Topic | CER anchor(s) | Status |
|---|---|---|---|
| §A | Administrative particulars (notified body, manufacturer, product, CER reference) | #executive-summary | Addressed (admin particulars are in the CER header + front-matter; the notified-body-side fields are completed by BSI in their own CEAR) |
| §B | Reviewers involved in the NB assessment | #qualification-of-the-responsible-evaluators | External (Section B is completed by the notified body; our side is the evaluator roster) |
| §C — device description | Device description, variants, accessories, previous generations | #device-description · #variants · #accessories-of-the-product · #previous-version-of-the-device | Addressed |
| §C — classification | Classification per MDR Article 51 | #scope-of-the-clinical-evaluation | Addressed |
| §C — clinical evaluation plan | CEP adequacy | #clinical-evaluation-plan | External (full CEP: R-TF-015-001) |
| §C — information materials | Information materials supplied to the user | #consistency-with-information-materials-supplied-by-the-manufacturer · #instructions-for-use | Addressed |
| §C — common specifications and harmonised standards | Standards applicability | #applicable-standards-and-guidance-documents | Addressed |
| §C — equivalence | Equivalence demonstration per Annex XIV Part A §3 | #demonstration-of-equivalence · #technical-equivalence · #clinical-equivalence · #biological-equivalence · #conclusions-regarding-equivalence | Addressed |
| §C — state of the art | SotA description | #current-knowledge---state-of-the-art | External (full SotA: R-TF-015-011) |
| §D | Clinical literature review — methodology, appraisal, data analysis | #clinical-data-collected-from-literature-search · #literature-search-plan · #appraisal-of-the-clinical-data-relating-to-the-device-under-evaluation · #results-of-the-literature-search-on-the-device-under-evaluation | Addressed |
| §E | Clinical investigations and related documentation | #pre-market-clinical-investigations · #methodological-justifications-and-statistical-adequacy | Addressed |
| §F | PMS, PMCF and the plan for updates | #clinical-data-generated-from-risk-management-and-pms-activities · #post-market-clinical-follow-up-data · #necessary-measures · #date-of-the-next-clinical-evaluation | Addressed |
| §G | IFU, SSCP, labelling and other information supplied with the device | #consistency-with-information-materials-supplied-by-the-manufacturer · #instructions-for-use | Addressed |
| Overall conclusions | Notified-body overall conclusion | #conclusions · #gspr-compliance · #sufficiency-determination | Addressed (our conclusions; NB fills in its own in the CEAR) |
| §I | Clinical evaluation consultation procedure (Article 54) | #methodology | N/A — the device is Class IIb MDSW; Article 54 consultation triggers (Rule 11 high-risk software meeting Annex IX §5.1) do not apply |
| §J | Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10)) | #clinical-evidence-strategy-and-regulatory-methodology | N/A — clinical data have been used; Article 61(10) is not invoked |
| §K | Voluntary clinical consultation on the clinical development strategy (Article 61(2)) | #methodology | N/A — no voluntary consultation was requested |
3. CER Template (Mantra Systems, Edition 2)
Reference: CER Template section transcriptions.
| Section | Topic | CER anchor(s) | Status |
|---|---|---|---|
| §1 | Administrative particulars | #executive-summary | Addressed |
| §2 | Executive summary | #executive-summary · #justification-of-sufficiency-of-clinical-evidence · #compliance-status-summary | Addressed |
| §3 | Scope of the clinical evaluation (3.1–3.10) | #scope-of-the-clinical-evaluation · #general-details · #objectives-of-the-clinical-evaluation-report · #device-description · #contraindications-and-precautions-required-by-the-manufacturer | Addressed |
| §4 | Clinical Evaluation Plan — Summary (4.1–4.5) | #clinical-evaluation-plan · #clinical-evidence-strategy-and-regulatory-methodology · #methodology | External (full CEP in R-TF-015-001) |
| §5 | Common specifications and harmonised standards | #applicable-standards-and-guidance-documents | Addressed |
| §6 | Clinical background, current knowledge, state of the art (6.1–6.6) | #current-knowledge---state-of-the-art · #data-sources-for-the-state-of-the-art | External (full SotA in R-TF-015-011) |
| §7 | Equivalence (7.1–7.4) | #demonstration-of-equivalence · #technical-equivalence · #clinical-equivalence · #biological-equivalence | Addressed |
| §8 | Clinical evidence review (8.1–8.6) | #clinical-data-generated-and-held-by-the-manufacturer · #clinical-data-collected-from-literature-search · #results-of-the-literature-search-on-the-device-under-evaluation | Addressed |
| §9 | Clinical evidence analysis — GSPRs (9.1–9.4) | #analysis-of-the-clinical-data · #requirement-on-safety · #requirements-on-acceptability-of-side-effects · #requirement-on-performance · #statement-on-the-conformity-with-general-safety-requirements-gspr-1 · #statement-on-the-conformity-with-general-performance-requirements-gspr-1 | Addressed |
| §10 | Clinical evidence analysis — Benefit-risk profile (10.1–10.5) | #requirement-on-acceptable-benefitrisk-profile · #benefits-assessment · #risk-management-and-residual-risks-acceptability · #assessment-of-the-benefitrisk-profile | Addressed |
| §11 | Conclusions | #conclusions · #gspr-compliance · #benefit-7gh-improvement-in-diagnostic-accuracy · #benefit-5rb-objective-severity-assessment · #benefit-3kx-care-pathway-optimisation | Addressed |
| §12 | Author CVs | #qualification-of-the-responsible-evaluators · #justification-of-the-level-of-evaluators-expertise | External (full CVs in Evaluation/Appendix/) |
| §13 | References | #references | Addressed |
| §14 | Excluded sources | #selection-of-references-relating-to-the-device-under-evaluation | External (detailed exclusion rationale in R-TF-015-011 State of the Art) |
4. CEP (R-TF-015-001) — MDCG 2020-1 pillar framework
Reference: R-TF-015-001 Clinical Evaluation Plan.
MDCG 2020-1 alignment is a paired responsibility: the CEP sets the pillar framework, the acceptance criteria, and the tiered evidence strategy; the CER reports against them. The rows below verify that each framework element the CER reports on is actually defined in the CEP, so the two documents cannot silently drift apart. CEP anchors are prefixed with cep: to distinguish them from CER anchors in the coherence check.
| CEP framework element | MDCG 2020-1 relevance | CEP anchor |
|---|---|---|
| Overall clinical evaluation strategy | Combined routes per MDCG 2020-6 § 6.4 | cep:#clinical-evaluation-strategy |
| Route A — Systematic Literature Review | Evidence identification (MDR Article 61(3)(a)) | cep:#route-a-systematic-literature-review |
| Route B — Equivalence with the legacy device | Equivalence demonstration (Annex XIV Part A §3; MDCG 2020-5) | cep:#route-b-equivalence-with-the-legacy-device |
| Route C — Own clinical investigations | Direct clinical evidence (Article 61(4); Articles 62–82) | cep:#route-c-own-clinical-investigations |
| Three-pillar evidence framework for MDSW | MDCG 2020-1 §3 — VCA, Technical Performance, Clinical Performance | cep:#three-pillar-evidence-framework-for-mdsw-mdcg-2020-1 |
| Planned tiered evidence assessment | Risk-proportionate assessment per MDCG 2020-6 Appendix III | cep:#planned-tiered-evidence-assessment |
| Planned paediatric subgroup analysis | Paediatric evidence planning | cep:#planned-paediatric-subgroup-analysis |
| Planned evidence classification per study | MDCG 2020-6 Appendix III rank assignment | cep:#planned-evidence-classification-per-study |
| Published severity validation literature — Pillar 2 | MDCG 2020-1 Pillar 2 (Technical Performance) | cep:#published-severity-validation-literature-mdcg-2020-1-pillar-2 |
| Published clinical performance literature — Pillar 3 | MDCG 2020-1 Pillar 3 (Clinical Performance) | cep:#published-clinical-performance-literature-mdcg-2020-1-pillar-3 |
| Planned appraisal methodology for investigations and publications | MEDDEV 2.7/1 Rev 4 Stage 2 — appraisal | cep:#planned-appraisal-methodology-for-clinical-investigations-and-published-manuscripts |
| Risk management plan | ISO 14971 linkage to clinical evaluation | cep:#risk-management |
| Safety endpoints | Safety objectives the CER benchmarks against SotA | cep:#safety-endpoints |
| Acceptability of the benefit-risk ratio | Decision criteria for GSPR 8 | cep:#acceptability-of-the-benefit-risk-ratio |
| State of the art scope | Defines the SotA the CER reports against | cep:#state-of-the-art |
| Intended clinical benefits | Claims the CER demonstrates achievement of | cep:#intended-clinical-benefits |
| PMS aspects needing regular CER update | Feedback loop driving CER refresh cadence | cep:#pms-aspects-that-need-regular-updating-in-the-clinical-evaluation-report |
| Post-Market Clinical Follow-up | PMCF planning that the CER's "Necessary measures" executes | cep:#post-market-clinical-follow-up-pmcf |
5. CEP → CER coherence pairs
Each row links a CEP section that sets a framework element to the CER section that reports against it. The script validates that both anchors resolve, so neither the CEP nor the CER can rename a heading without breaking CI. This is the audit guarantee that the CEP and CER stay in lock-step on MDCG 2020-1 structure.
| CEP section → CER section | Coherence meaning |
|---|---|
cep:#clinical-evaluation-strategy → #clinical-evidence-strategy-and-regulatory-methodology | The strategy planned in the CEP is the strategy executed and reported in the CER |
cep:#route-a-systematic-literature-review → #combined-evidence-strategy-routes-a-b-and-c | Route A plan → Route A execution narrative |
cep:#route-b-equivalence-with-the-legacy-device → #demonstration-of-equivalence | Route B plan → Equivalence demonstration |
cep:#route-c-own-clinical-investigations → #clinical-data-generated-and-held-by-the-manufacturer | Route C plan → Own-investigation evidence |
cep:#three-pillar-evidence-framework-for-mdsw-mdcg-2020-1 → #mdcg-2020-1-three-pillar-evidence-framework-for-mdsw | MDCG 2020-1 pillars defined → pillars reported against |
cep:#planned-tiered-evidence-assessment → #tiered-evidence-assessment-strategy | Tier definition → tier-by-tier reporting |
cep:#published-severity-validation-literature-mdcg-2020-1-pillar-2 → #appraisal-of-published-severity-validation-literature-mdcg-2020-1-pillar-2 | Pillar 2 literature plan → Pillar 2 appraisal results |
cep:#published-clinical-performance-literature-mdcg-2020-1-pillar-3 → #appraisal-of-published-malignancy-clinical-evidence-mdcg-2020-1-pillar-3 | Pillar 3 literature plan → Pillar 3 appraisal results |
cep:#planned-appraisal-methodology-for-clinical-investigations-and-published-manuscripts → #validated-methodological-quality-appraisal | Appraisal methodology planned → QUADAS-2 / MINORS appraisal applied |
cep:#risk-management → #risk-management-and-residual-risks-acceptability | Risk management plan → residual-risk acceptability |
cep:#safety-endpoints → #safety-benchmarking-against-state-of-the-art | Safety endpoints defined → benchmarked against SotA |
cep:#acceptability-of-the-benefit-risk-ratio → #assessment-of-the-benefitrisk-profile | Acceptability criteria → benefit-risk assessment conclusion |
cep:#state-of-the-art → #current-knowledge---state-of-the-art | SotA scope defined → SotA summarised (full analysis in R-TF-015-011) |
cep:#intended-clinical-benefits → #clinical-benefits | Benefits claimed → benefits reported |
cep:#pms-aspects-that-need-regular-updating-in-the-clinical-evaluation-report → #pms-and-pmcf-feedback-loop | PMS-driven CER updates planned → feedback loop documented |
cep:#post-market-clinical-follow-up-pmcf → #necessary-measures | PMCF plan → PMCF execution narrative |
6. MDCG 2020-1 (MDSW clinical evaluation guidance) — section coverage
Reference: MDCG 2020-1 section transcriptions. Source PDF: apps/qms/docs/applicable-standards-and-regulations/04-eu-medical-devices/Guides/04-g07-mdcg-2020-1-clinical-evaluation-mdsw/04-g07-mdcg-2020-1-clinical-evaluation-mdsw.pdf (22 pages, March 2020).
MDCG 2020-1 is the guidance document that establishes the three-pillar framework for MDSW clinical evaluation — Valid Clinical Association (VCA) / Scientific Validity as Pillar 1, Technical Performance / Analytical Performance as Pillar 2, and Clinical Performance as Pillar 3 — plus the methodology for integrating them (Annex I). Because this device is a Class IIb Medical Device Software, MDCG 2020-1 is the primary MDSW-specific clinical evaluation guidance the CEP and CER must align against. This section maps each relevant MDCG 2020-1 sub-section to the anchor in the CEP where the framework element is set and to the anchor in the CER where it is reported.
| MDCG 2020-1 section | Framework element | CEP anchor (where set) | CER anchor (where reported) |
|---|---|---|---|
| §3.3 Definitions (VCA, Scientific Validity, Technical Performance, Clinical Performance, MDSW) | Regulatory definitions adopted verbatim | cep:#acronyms-and-definitions | #mdcg-2020-1-three-pillar-evidence-framework-for-mdsw |
| §4.1 Introduction — iterative three-pillar process | MDSW process overview | cep:#three-pillar-evidence-framework-for-mdsw-mdcg-2020-1 | #mdcg-2020-1-three-pillar-evidence-framework-for-mdsw |
| §4.2 Determination of valid clinical association / scientific validity (Pillar 1) | VCA evidence via systematic literature | cep:#route-a-systematic-literature-review | #combined-evidence-strategy-routes-a-b-and-c |
| §4.3 Technical Performance / Analytical Performance (Pillar 2) | Algorithm-level technical performance evidence (published severity validation studies, AI model V&V documentation, LegitHealth-DX dataset validation) | cep:#published-severity-validation-literature-mdcg-2020-1-pillar-2 | #three-pillar-evidence-framework-for-mdsw-mdcg-2020-1 |
| §4.4 Clinical Performance (Pillar 3) | Clinical performance evidence (prospective real-patient clinical investigations; MRMC simulated-use reader studies as supporting Pillar 3 evidence at Rank 11) | cep:#published-clinical-performance-literature-mdcg-2020-1-pillar-3 | #three-pillar-evidence-framework-for-mdsw-mdcg-2020-1 |
| §4.4.1 Clinical investigations and clinical performance studies | Own clinical investigations under Articles 62–82 | cep:#route-c-own-clinical-investigations | #clinical-data-generated-and-held-by-the-manufacturer |
| §4.4.2 Where demonstration of conformity based on clinical data is not deemed appropriate (Article 61(10)) | Exception route | — | #clinical-evidence-strategy-and-regulatory-methodology (N/A — not invoked for this device) |
| §4.5 Final analysis and conclusion | Sufficiency determination | cep:#summary-of-the-combined-strategy | #sufficiency-determination |
| §4.6 Continuous update of the clinical evaluation | Update cadence (Article 61(11) + Article 86) | cep:#pms-aspects-that-need-regular-updating-in-the-clinical-evaluation-report | #date-of-the-next-clinical-evaluation |
| Annex I — Methodological principle for generation of clinical evidence | Three-pillar integration into a single evidence body | cep:#planned-appraisal-methodology-for-clinical-investigations-and-published-manuscripts | #clinical-evidence-assessment-framework |
| Annex II — Examples of clinical evaluation strategies | Worked examples (Example b, MDSW for image segmentation, is the closest analogue to this device) | — | — (reference material only) |
6.1. MDCG 2020-1 → CEP → CER coherence pairs (pillar framework)
These pairs enforce that the MDCG 2020-1 pillar definitions set in the CEP have a corresponding reporting anchor in the CER. The script validates both anchors and fails CI if either is renamed or removed.
| MDCG 2020-1 anchor | CEP anchor → CER anchor |
|---|---|
| §4.1 / §4.2 Pillar 1 (VCA) | cep:#route-a-systematic-literature-review → #combined-evidence-strategy-routes-a-b-and-c |
| §4.3 Pillar 2 (Technical Performance) | cep:#published-severity-validation-literature-mdcg-2020-1-pillar-2 → #appraisal-of-published-severity-validation-literature-mdcg-2020-1-pillar-2 |
| §4.4 Pillar 3 (Clinical Performance) | cep:#published-clinical-performance-literature-mdcg-2020-1-pillar-3 → #appraisal-of-published-malignancy-clinical-evidence-mdcg-2020-1-pillar-3 |
| §4.4.1 Clinical investigations | cep:#route-c-own-clinical-investigations → #clinical-data-generated-and-held-by-the-manufacturer |
| §4.6 Continuous update | cep:#pms-aspects-that-need-regular-updating-in-the-clinical-evaluation-report → #pms-and-pmcf-feedback-loop |
Verification
Run locally:
node apps/qms/scripts/check-cer-coverage.mjs
The script performs three checks:
- CER anchor resolution — every #slug reference in sections 1–3 of this matrix resolves to a real heading in
R-TF-015-003 Clinical Evaluation Report. - CEP anchor resolution — every cep:#slug reference in section 4 resolves to a real heading in
R-TF-015-001 Clinical Evaluation Plan. - CEP → CER coherence — every cep:#a → #b pair in section 5 has BOTH anchors resolving, so the pillar framework set in the CEP has a live reporting counterpart in the CER.
Slugifier is github-slugger-compatible: lowercase, strip punctuation, convert each whitespace character to a hyphen (no multi-hyphen collapse), de-duplicate with -1, -2, … The CI build fails closed on any unresolved reference.
Change control
If you add or rename a heading in either the CER or the CEP, the script will fail. Either update this matrix to point at the new anchor, or restore the old heading. BSI auditors rely on this mapping; it must never silently drift. In particular, renaming a heading in the CEP without checking coherence pairs would silently decouple the CEP's framework from the CER's reporting — the script exists precisely to prevent that.