Role headers for each audit-visible PMS document

Each role-statement paragraph goes immediately under the top-level heading of the target file. Phrasing is deliberately parallel across the four audit-visible documents so the reader can compare them at a glance.

1. Umbrella PMS Plan — r-tf-007-005-legacy-pms-plan.mdx

Role of this document. This is the umbrella Post-Market Surveillance Plan for the legacy version of the device (internal reference: legacy device, Class I under MDD 93/42/EEC, continued on the market under MDR Article 120(3) transitional provisions). It is the Plan at the top of the two-tier legacy post-market documentation hierarchy: it scopes all proactive and passive surveillance streams, defines indicators and threshold values for benefit-risk reassessment, and plans the production of the paired umbrella Post-Market Surveillance Report (R-TF-007-003). One proactive surveillance stream described in this Plan is delivered through a nested study-specific cross-sectional observational study, whose Protocol is held as R-TF-015-012 and whose Report is held as Appendix D to R-TF-015-012. See the hierarchy diagram below.

2. Umbrella PMS Report — r-tf-007-003-legacy-pms-report.mdx

Role of this document. This is the umbrella Post-Market Surveillance Report for the legacy version of the device, prepared per MDR Article 85 applicable to the legacy Class I device via MDR Article 120(3). It is the Report at the top of the two-tier legacy post-market documentation hierarchy: it consolidates the results and conclusions of every surveillance stream planned in the umbrella PMS Plan (R-TF-007-005) across the reporting period, combining passive surveillance (complaints, vigilance, trend analysis) with proactive surveillance (the cross-sectional observational study whose Protocol is R-TF-015-012 and whose Report is Appendix D to R-TF-015-012). See the hierarchy diagram below.

3. Study-specific Protocol — r-tf-015-012-legacy-pms-cross-sectional-study-protocol.mdx

Role of this document. This is the study-specific Protocol for the cross-sectional observational study that delivers the proactive surveillance stream planned in the umbrella PMS Plan (R-TF-007-005). It sits nested inside the umbrella Plan; its conclusions feed into the umbrella PMS Report (R-TF-007-003). The study is a post-market proactive surveillance activity under MDR Article 83 (applicable to the legacy Class I device via MDR Article 120(3)), classified as Rank 4 evidence for its quantitative outcomes and Rank 8 for its Likert professional-opinion items per MDCG 2020-6 Appendix III, and enters the successor device's clinical evaluation under MDCG 2020-6 §6.2.2 via the MDCG 2020-5 equivalence route documented in the Clinical Evaluation Plan (R-TF-015-001). Its data-collection artefacts are Appendix A (Cover letter), Appendix B (Physician questionnaire), Appendix C (Anonymised respondent dataset, held by the manufacturer within the QMS), and Appendix D (Study Report).

4. Study-specific Report — r-tf-015-012-legacy-pms-cross-sectional-study-report.mdx

Role of this document. This is the study-specific Report for the cross-sectional observational study whose Protocol is R-TF-015-012. It is Appendix D to that Protocol and sits nested inside the umbrella PMS Report (R-TF-007-003), where a summary of its endpoint-level results appears alongside the passive surveillance streams. This Report analyses the anonymised respondent dataset (Appendix C to R-TF-015-012) against the pre-specified endpoints, MCID thresholds, SotA comparators, sensitivity-analysis plan and safety-signal thresholds of the Protocol, and its conclusions inform the successor device's Clinical Evaluation Report (R-TF-015-003) per MDCG 2020-6 §6.2.2.

5. Unchanged supporting documents

The questionnaire (questionnaire.mdx, Appendix B to R-TF-015-012) and the cover letter (cover-letter.mdx, Appendix A to R-TF-015-012) do not receive role-header edits in this refactor. Their titles already name them as appendices; their role is already audit-legible.

6. Where the role headers sit structurally

In every file the order is:

1. Frontmatter (title, hide_table_of_contents, etc.).
2. Top-level H1 heading (unchanged).
3. Optional one-line summary / metadata block (unchanged where present).
4. Role header block (the blockquote above).
5. Hierarchy diagram (mermaid block) — only on the two umbrella documents.
6. Rest of the existing body.

The role header is a blockquote rather than a level-2 heading because it is a meta-statement about the document's identity rather than a content section. This keeps the document's existing section numbering intact and avoids breaking downstream cross-references that point to specific section numbers.