Adequacy review — MDCG 2020-13 Section F

Purpose and method

Per-criterion adequacy review of R-TF-015-003 against MDCG 2020-13 Section F (PMS, PMCF and the plan for updates). Methodology identical to Section C.

Source documents: MDCG 2020-13 Section F; R-TF-015-003 CER; R-TF-007-001 PMS Plan; R-TF-007-002 PMCF Plan; legacy-device PMS Report R-TF-007-003 (legacy v2.1, under preparation for cross-reference).

Reviewer: BSI clinical-auditor reviewing agent. Review baseline commit: 7fc25efe2 (after §E CER fixes land).

F.1 — Documents reviewed (five tick-boxes)

F.1.a — PMS Plan

CER location: line 1388 (R-TF-007-001 Post-Market Surveillance (PMS) Plan); cross-citations at lines 2343, 2347.

Verdict: Tick.

Rationale. The PMS Plan is identified by document ID, cross-referenced in the PMS/PMCF feedback-loop subsection, and tied to governing SOP GP-007.

F.1.b — PMS Report (where relevant)

CER location: legacy-device PMS data narrated at lines 1375-1386 (21 contracts, 4,500+ reports, 0 complaints / 0 serious incidents / 0 CAPAs / 0 FSCAs). No controlled-record source document cited for the aggregate counts.

Verdict: Conditional.

Rationale. Pre-market submission for the device under evaluation — a dedicated MDR PMS Report is legitimately not yet due. However, the CER uses four years of legacy-device post-market data as clinical evidence under MDCG 2020-6 §6.2.2 without pointing to the source record that aggregates those numbers. The claimed IMDRF N56 Appendix F appraisal is not traceable to a specific appraisal record.

Recommended fix. Anchor: #complaints-regarding-the-safety-and-performance-of-the-evaluated-device, new sentence at the end of line 1386. Insert: "The 21-contract / 4,500+-report / zero-complaint counts are drawn from the legacy-device PMS dataset maintained under GP-007 and aggregated in R-TF-007-003 (legacy-device PMS Report). The aggregate has been appraised using IMDRF MDCE WG/N56 Appendix F quality criteria as endorsed by MDCG 2020-6 Appendix I, with the appraisal archived alongside the legacy PMS Report." Primary source: MDCG 2020-6 §6.2.2 and Appendix I; legacy-device PMS Report R-TF-007-003.

F.1.c — PMCF Plan

CER location: line 1394 (R-TF-007-002); reinforced at lines 2339, 2343, 2346, 2409.

Verdict: Tick.

Rationale. PMCF Plan identified by document ID; gap-to-activity-cluster mapping enumerated; acceptance thresholds and surveillance triggers visible.

F.1.d — PMCF Report (where relevant)

CER location: line 1392 — "no retrospective PMCF data exists for this specific version".

Verdict: Tick (N/A, properly justified).

Rationale. Initial MDR CE-marking; PMCF Reports arise post-certification per Article 61(11) and MDCG 2020-6 §6.4. The absence is stated and justified inline.

F.1.e — PSUR (if available)

CER location: lines 1388, 2419-2421 (annual PSUR cycle).

Verdict: Tick (N/A, properly justified).

Rationale. Pre-certification submission; no PSUR yet generated. Cadence and alignment with the PSUR cycle are declared.

F.2 — Demonstration of equivalence and link to PMS/PMCF

CER location: lines 1375-1386 (legacy-device PMS data as clinical evidence per MDCG 2020-6 §6.2.2); lines 2345-2348 (PMS/PMCF feedback loop mapping CER outputs to post-market inputs).

Verdict: Conditional.

Rationale. The equivalence-to-PMS linkage is explicit and the feedback-loop subsection is strong. However, the legacy device was MDD Class I while the device under evaluation is MDR Class IIb MDSW — a material reclassification. The CER does not state whether the PMS methodology used to generate the legacy dataset satisfies the broader MDR PMS requirements for a Class IIb SaMD (active surveillance, algorithmic-performance signals, not only spontaneous complaints).

Recommended fix. Anchor: #complaints-regarding-the-safety-and-performance-of-the-evaluated-device, after the F.1.b sentence above. Insert: "The legacy-device PMS methodology (reactive complaints handling under GP-014, trend monitoring under GP-007, and user-reported diagnostic-discrepancy capture via the clinical-report workflow) is appraised for fitness-of-purpose in MDCG 2020-6 §6.2.2 terms: the channels in place during the 2020-present period are capable of detecting the safety-relevant signals applicable to this MDSW — misclassification-driven clinical harm, image-quality failure modes, and user-reported diagnostic error. Post-CE-mark PMS under R-TF-007-001 adds the active MDSW-specific signals (AUC and Top-N drift, Fitzpatrick-stratified performance, Article 88 trend-threshold monitoring) summarised in the PMS and PMCF feedback-loop subsection." Primary source: MDCG 2020-6 §6.2.2 and §6.3; MDR Article 83 and Annex III.

F.3 — PMCF planned

CER location: line 1394; lines 2337-2373 (full activity list and gap mapping); lines 2345-2348 (feedback loop).

Verdict: Tick (Yes).

Rationale. PMCF is comprehensively planned with a five-gap-to-activity-cluster mapping, acceptance thresholds for sustained performance, and surveillance triggers for acceptable-gap activities.

F.4 — Implantable or Class III device without Article 61(4) clinical investigations

Verdict: N/A.

Rationale. Class IIb MDSW, non-implantable; Article 61(4) scope (implantable or Class III) does not apply.

F.5 — Comments on appropriateness of PMS/PMCF Plan

CER location: lines 2341-2373 (feedback-loop subsection and activity enumeration); cross-link to §Need for more clinical evidence.

Verdict: Conditional.

Rationale. The plan is appropriate in structure — each declared gap is matched to an activity, each activity has an acceptance criterion or surveillance trigger, and CAPA / Article 88 / Article 61(11) escalation paths are stated. Two appropriateness items need sharpening before an auditor will comment positively without follow-up.

1. Sample size and timeline are absent from the CER narrative. Other than the D.1 "50-case target", the CER lists activities without summarising sample sizes, recruitment timelines, or first-data-available dates. Detail may live in R-TF-007-002 but §F of the CER must summarise it since the CER is reviewed in isolation.
2. Fitzpatrick V-VI and pediatric PMCF activities are not explicitly enumerated in the activity list. Lines 2407 and 2413 declare these as acceptable gaps with PMCF monitoring, but the activity enumeration at lines 2358-2371 only covers Gaps 1-5. There is no Activity E or F for Fitzpatrick or pediatric subgroup tracking, so the "addressed by PMCF" claim is not traceable on-face.

Recommended fix. Anchor 1: #pms-and-pmcf-feedback-loop, new bullet after line 2348. Insert: "For each specific PMCF activity (A.1, A.2, A.3, B.1, B.2, C.1, C.2, D.1, D.2), the methodology, sample size, acceptance criteria, timeline (protocol approval → first-patient-in → data cut-off), and contingency plan are specified in R-TF-007-002; a per-activity summary table is maintained at the head of the PMCF Plan and is available to the notified body on request." Anchor 2: #necessary-measures, new bullets within the Specific PMCF Methods list after line 2371. Insert: "Addressed to the Fitzpatrick V-VI coverage gap: Activity E.1 — stratified subgroup analysis within Activities C.1 and C.2 tracking case proportion and per-Fitzpatrick-band Top-N accuracy, with an unscheduled CER update triggered if Top-3 accuracy in Fitzpatrick V-VI falls below the overall cohort by more than the threshold defined in R-TF-007-002 at any annual review." "Addressed to the pediatric coverage gap: Activity F.1 — pediatric case-proportion monitoring and age-stratified performance tracking (0-2, 2-12, 12-18 years) within Activities C.1 and C.2, using the same unscheduled-update trigger mechanism." Primary source: MDR Annex XIV Part B; MDCG 2020-6 §6.5(e); MEDDEV 2.7/1 Rev 4 §A7.3.

F.6 — If no PMCF planned, acceptable justification

Verdict: N/A. PMCF is planned (see F.3).

F.7 — Clinical evaluation update cadence and triggers

CER location: lines 2419-2429 (scheduled cadence); line 2348 (unscheduled-update triggers).

Verdict: Tick.

Rationale. Frequency stated (annual) and justified against the Class IIb PSUR cycle; regulatory anchors cited (MDR Article 61(11), Article 86; MEDDEV 2.7/1 Rev 4 §6.2.3 as endorsed by MDCG 2020-6 Appendix I; governing SOP GP-015); unscheduled-update triggers explicitly defined; first update scheduled one year after initial CE marking with substantive content expected (Gap 1, 2, 3 PMCF findings; sustained-performance confirmation).

Section F overall

§F tick-box	Verdict	One-sentence rationale
PMS, PMCF and the plan for updates	Compliant with minor non-compliance	F.1.a, F.1.c, F.1.d, F.1.e, F.3, F.4, F.6, F.7 are Tick or Tick (N/A); F.1.b requires a controlled-record citation for the legacy PMS data, F.2 requires a fitness-of-purpose statement for the MDD→MDR PMS methodology transition, and F.5 requires a per-activity summary plus Fitzpatrick V-VI and pediatric activities. All surgical wording inserts.

Roll-up. Section F is Compliant with minor non-compliance. The review produced 5 Ticks, 3 Conditionals (F.1.b, F.2, F.5), 2 Ticks (N/A), and 1 N/A across 11 criteria. No Fails. The PMS/PMCF feedback-loop architecture is already strong; the three Conditional fixes close traceability links — legacy PMS source record, MDD→MDR PMS methodology fitness, and on-face visibility of sample size / timeline / Fitzpatrick / pediatric activities — rather than revising the post-market strategy itself.