Response

Fix

We have updated the R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan to include a comprehensive Data Sufficiency Justification, demonstrating how the totality of our PMCF activities fulfills the requirement for continuous, lifetime clinical evaluation as per MDR Annex XIV Part B.

Response to BSI

We have revised the R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan to provide an overall 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.

Specifically, 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, addressing the concern regarding continuity beyond the initial 2026 study phase.
• 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.