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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health version 2.1 (Legacy MDD)
  • Legit.Health US Version 1.1.0.0
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • BSI Non-Conformities
    • Marketing material MDD Web and IFUs
    • Technical Review
    • Clinical Review
      • Round 1
        • Item 0: Background & Action Plan
        • Item 1: CER Update Frequency
        • Item 2: Device Description & Claims
        • Item 3: Clinical Data
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
          • Request A: PMCF Activity Descriptions
          • Request B: PMCF Data Sufficiency Justification
            • Question
            • Research and planning
            • Response
          • Message for Jordi: PMCF Plan Section D needed
        • Item 7: Risk
        • completed-tasks
        • Coverage matrix
        • BSI Round-1 Submission: Export Plan
        • resources
      • Evidence rank & phases
      • Pre-submission review of R-TF-015-001 CEP and R-TF-015-003 CER
  • Pricing
  • Public tenders
  • Trainings
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • Item 6: PMCF Plan
  • Request B: PMCF Data Sufficiency Justification
  • Response

Response

We have updated R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan to include a comprehensive Data Sufficiency Justification demonstrating that the planned activities will collect sufficient data in quality and quantity to confirm the benefit, safety, and performance of the device over its expected lifetime, in accordance with MDR Annex XIV Part B.

The following key sections have been added or updated:

  • Data Sufficiency Justification: A new section explicitly outlines how the combination of routine post-market surveillance (General Methods) and the 11 targeted clinical activities (Specific Methods) generates statistically sound and methodologically rigorous evidence covering the device's 5-year expected lifetime.

  • Comprehensive Coverage Mapping: We have provided an explicit matrix mapping the PMCF activities to:

    • Every specific clinical performance claim (benefit 7GH for diagnostic accuracy, benefit 5RB for severity measurement, benefit 3KX for care pathway optimisation).
    • All identified residual risks with clinical impact from the Risk Management File (e.g., R-75H, R-DAG, R-AGQ).
    • All intended user populations (HCPs and ITPs).
    • Both declared evidence coverage gaps per MDCG 2020-6 § 6.5(e): Gap 4 (autoimmune diseases, 3% of presentations) addressed by Activity D.1 (prospective surveillance, 50-case target, Top-3 accuracy >= 60%), and Gap 5 (genodermatoses, 1%) addressed by Activity D.2 (passive surveillance, safety-trigger-based). This mapping ensures that the CER's acceptable gap declarations are supported by specific, linked PMCF activities.

  • Continuous Evaluation Lifecycle: The plan now explicitly describes the continuous, annual lifecycle of the PMCF program. It outlines how data from the 11 planned activities will be integrated into the PMCF Evaluation Report and PSUR, feeding directly into the annual Clinical Evaluation Report (CER) updates. This process ensures continuous reassessment of gaps and triggers subsequent monitoring cycles throughout the device's market life, in accordance with MDR Article 61(11) and Annex XIV Part B.

  • Equivalent/Similar Device Evaluation: In accordance with Annex XIV 6.2(a), we have added an evaluation of published clinical data relating to similar AI-based dermatology devices (such as SkinVision, DERM, Dermalyser, etc.). This section confirms that the PMCF program proactively monitors the state-of-the-art to ensure the performance and safety thresholds of the device remain aligned with or superior to current market standards.

  • Integration of the equivalent legacy device's post-market conclusions as a named input to the PMCF Plan (MDCG 2020-6 §6.2.2). Two new subsections have been added to R-TF-007-002 that route the conclusions of the equivalent legacy device's post-market programme into the PMCF Plan as structural inputs rather than decorative citations. The first, Residual uncertainties from legacy PMS: confirmation in PMCF, maps each of the legacy cross-sectional observational study's three acknowledged residual uncertainties — physician-reported perceived outcomes, cross-sectional design with retrospective recall, and attribution uncertainty — to the existing PMCF activities that confirm and strengthen them through independently-measurable, longitudinal and before-and-after designs: Activities B.1 through B.5 deliver independently-measurable severity outcomes against expert consensus on device-captured images; Activity A.2 delivers histopathology and clinical-outcome reference standards for melanoma follow-up prioritisation; Activity C.1 delivers multireader performance metrics; Activity A.1 delivers large-scale retrospective longitudinal evidence with temporal stratification; Activity D.1 delivers prospective surveillance with interim analyses at defined case counts; and Activities A.1, A.2, A.3 and C.2.2 deliver site-stratified before-and-after and paired-read designs that isolate the device's contribution from secular or workflow trends. The framing is strictly confirmatory under MDCG 2020-6 §6.3: the legacy evidence remains a valid post-market input and the PMCF activities strengthen it; the legacy evidence is not treated as a pre-cert gap to be filled or closed. The second, Evidence-quality substantiation: continuity from legacy PMS, applies the evidence-quality substantiation principle established in the legacy study (protocol Section 10.7, extending the Section 8.4 principle for quantitative endpoints symmetrically to binary-with-free-text safety items) to every quantitative PMCF data batch under Activities A, B, C and D. The records-consulted threshold (at least 35.9% of each quantitative batch must be records-based rather than estimate-based) is carried forward from the legacy study's pre-specified data-source sensitivity analysis, and when the threshold is not met the PMCF response is to repeat collection rather than adjust conclusions.

  • Integration into the Plus PMS Plan and CER. The same five-point integration is mirrored in R-TF-007-001 Post-Market Surveillance (PMS) Plan (Benefit confirmation — continuity with legacy evidence; Carried-forward safety-signal baselines from legacy post-market; Surveillance cadence — calibrated against legacy-device operational experience) and in R-TF-015-003 Clinical Evaluation Report (PMS and PMCF feedback loop, bullet "Integration of the equivalent legacy device's post-market conclusions"). No new benefits or performance claims are introduced; the integration ensures that the Plus post-market programme is demonstrably informed by the equivalent legacy device's four-plus-year market experience rather than written from a clean slate.

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Message for Jordi: PMCF Plan Section D needed
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