Information_for_answers

The purpose of this document is to answer your questions and address the deficiencies identified by the BSI auditor in Item 3a. This document should serve as a source of context for your questions and help you respond to the BSI auditor regarding Item 3a, as well as provide any other necessary clarifications. it is important to highlight that if this information is not inserted in the Clinical Investigation Plan or Clinical investigation Report of the studies, it should be added in these documents with the corresponding redline, and the reference to the section/page where this information is included should be provided in the answer to BSI.

Critical Gaps (Must Fix)

P1 — No single consolidated prose section in the CER (the actual kanban task)

The CER needs a dedicated section titled something like "Clinical evidence strategy and regulatory methodology" placed between "How to read this
CER" and "Scope of the clinical evaluation"
Must be continuous prose (not tables), using exact MDR Art. 61(1), Annex XIV(2), MDCG 2020-1, MDCG 2020-6 Section 6.4, and MEDDEV 2.7.1 Rev 4
terminology
Must narrate: (a) regulatory obligation, (b) combined evidence routes A/B/C, (c) three-pillar mapping, (d) evidence ranking per MDCG 2020-6
Appendix III, (e) tiered structure rationale, (f) pre-market sufficiency statement

P2 — CEP's combined evidence strategy (Routes A/B/C) is not reproduced in the CER

The CER at line 193 just says "refer to R-TF-015-001" — BSI will not read it
This content must be summarized or reproduced directly in the CER

P5 — response.mdx doesn't reference the new CER section

The response must tell BSI exactly where to find the validation strategy: section name + heading. Without this, BSI cannot locate the fix.

Secondary Gaps (Should Fix)

P3 — MEDDEV Stage narration is mechanical

Lines 230-238 list stages but don't say what was found or decided at each stage
Needs one substantive outcome sentence per stage

P4 — Validated appraisal tool naming is incomplete

CRIT1-7 is used but not mapped to MDCG 2020-6 Section 6.3 recognised tools (IMDRF Appendix F, Newcastle-Ottawa Scale)

P6 — CEP Appendix III hierarchy checklist table

Ranks 5, 7, 8 may still be marked "No" despite equivalence and PMS data being used — needs verification

Prioritized Action Items

┌──────────┬──────────────────────────────────────────────────────────────────────────────────────────────────────────┬────────────────┐
│ Priority │ Action │ Effort │ ├──────────┼──────────────────────────────────────────────────────────────────────────────────────────────────────────┼────────────────┤ │ P1 │ Write the consolidated "Clinical evidence strategy" prose section in the CER with full MDR/MDCG language │ 3–5 hours │ ├──────────┼──────────────────────────────────────────────────────────────────────────────────────────────────────────┼────────────────┤ │ P2 │ Reproduce CEP Routes A/B/C with regulatory basis in the new CER section │ included in P1 │
├──────────┼──────────────────────────────────────────────────────────────────────────────────────────────────────────┼────────────────┤
│ P5 │ Update response.mdx to reference the new CER section by heading │ 30 min │
├──────────┼──────────────────────────────────────────────────────────────────────────────────────────────────────────┼────────────────┤
│ P3 │ Enhance MEDDEV stage narration with per-stage outcome summaries │ 1 hour │ ├──────────┼──────────────────────────────────────────────────────────────────────────────────────────────────────────┼────────────────┤
│ P4 │ Map CRIT1-7 to Newcastle-Ottawa/IMDRF Appendix F per MDCG 2020-6 §6.3 │ 1 hour │ ├──────────┼──────────────────────────────────────────────────────────────────────────────────────────────────────────┼────────────────┤
│ P6 │ Verify/correct CEP Appendix III checklist table (Ranks 5, 7, 8) │ 30 min │ └──────────┴──────────────────────────────────────────────────────────────────────────────────────────────────────────┴────────────────┘

Key Files

CER: apps/qms/docs/.../R-TF-015-003-Clinical-Evaluation-Report.mdx
CEP: apps/qms/docs/.../R-TF-015-001-Clinical-Evaluation-Plan.mdx
Item 3a response: .../item-3-clinical-data/ra-clinical-data-analysis/response.mdx
Item 3a research-and-planning: .../ra-clinical-data-analysis/research-and-planning.mdx

Bottom line: The task is fundamentally about writing one new prose section in the CER that consolidates what is currently scattered, reproduces the
CEP's Routes A/B/C strategy with MDR/MDCG citation, and gives BSI a single place to verify the validation strategy. Everything else is refinement. Do you want me to draft this section now?