Target document hierarchy — legacy MDD post-market surveillance

Scope note. This file is the internal working record for task-3b10. The ambitious path (minted R-number + filename renames + role headers + hierarchy diagrams + full cross-reference sweep) was selected on 2026-04-20 per Taig's "full scope" instruction, overriding the default minimum-viable path in the task CLAUDE.md. Every audit-visible document is reshaped so a BSI auditor reading the exported PDF can tell the umbrella level from the study-specific level without internal explanation.

1. The two-tier model

Under the legacy MDD regime (MDD Annex II / Annex V, with MDR Article 120(3) dragging Article 83–88 obligations onto the legacy device during the transition window), the legacy-device post-market programme is a two-tier structure:

• Umbrella tier — covers the whole legacy device: surveys, feedback and complaints, vigilance (serious incidents and FSCAs), trend analysis, and the supplementary proactive study. One Plan + one Report at this tier.
• Study-specific tier — the one proactive cross-sectional observational study (Rank 4 per MDCG 2020-6 Appendix III "high quality surveys may also fall into this category"). It has its own Protocol + its own Report, both nested inside the umbrella tier.

The parent-child relationship: the study-specific Protocol is cited by the umbrella Plan as one proactive surveillance stream among several; the study-specific Report is cited by the umbrella Report as one section among several.

2. Roles, files and R-numbers

Role	File (post-refactor)	R-number	Relationship
Umbrella PMS Plan (legacy, MDD)	r-tf-007-005-legacy-pms-plan.mdx	R-TF-007-005 (new)	Parent to the umbrella Report and to the study-specific Protocol
Umbrella PMS Report (legacy, MDD, Article 85)	r-tf-007-003-legacy-pms-report.mdx (renamed for consistency)	R-TF-007-003	Child of the umbrella Plan; parent-peer to the study-specific Report
Study-specific Protocol (supplementary study)	r-tf-015-012-legacy-pms-cross-sectional-study-protocol.mdx	R-TF-015-012	Child of the umbrella Plan; cited as one proactive surveillance stream
Study-specific Report (supplementary study)	r-tf-015-012-legacy-pms-cross-sectional-study-report.mdx	Appendix D to R-TF-015-012	Child of the study-specific Protocol and of the umbrella Report
Physician questionnaire (Appendix B to R-TF-015-012)	questionnaire.mdx (unchanged)	Appendix B to R-TF-015-012	Data-collection instrument for the study-specific Protocol
Cover letter (Appendix A to R-TF-015-012)	cover-letter.mdx (unchanged)	Appendix A to R-TF-015-012	Distribution artefact for the study-specific Protocol

3. R-number discipline

• R-TF-007-001 is not available — reserved for the Plus-device PMS Plan (MDR Class IIb). Re-using it would conflate two devices under two regulatory regimes.
• R-TF-007-002 is not available — reserved for the Plus-device PMCF Plan.
• R-TF-007-003 is currently in use as the legacy-device umbrella PMS Report. The legacy document inherits a deprecated Plus slot (the 2023 Plus PSUR, retired to deprecated/). This collision is pre-existing; fixing it is out of scope for task-3b10.
• R-TF-007-004 is burned — a deprecated Plus PMS Report lives at deprecated/R-TF-007-004-Post-Market-Surveillance-PMS-Report.mdx. Do not re-use.
• R-TF-007-005 was previously held by a Plus PMCF Evaluation Report stub at post-market-surveillance/others/R-TF-007-005-Post-Market-Clinical-Follow-up-PMCF-Report.mdx (dormant Feb-2025 template, never populated with PMCF data because the Plus device is pre-MDR-CE-mark). During this refactor that stub was git mvd to post-market-surveillance/deprecated/, the now-empty others/ folder was removed, and the Plus STED was re-bound to R-TF-007-006 for the forward-looking PMCF Evaluation Report slot. R-TF-007-005 is therefore now minted here for the new legacy umbrella PMS Plan. Chosen to keep both legacy umbrella documents (Plan + Report) inside the R-TF-007-* series, so a reader who sees R-TF-007-003 (legacy Report) immediately looks for its companion Plan in the same range.
• R-TF-007-006 is reserved — re-bound during this refactor to the Plus PMCF Evaluation Report (forward-looking slot). Previously unused in any audit-visible document.
• R-TF-015-012 — kept. The filename change removes the "PMS Study Protocol" ambiguity (a title that naturally reads as "the umbrella PMS plan"); the R-number itself is unambiguous in context because it sits in the R-TF-015-* Clinical Evaluation series, signalling that it is a CIP-equivalent clinical-evaluation input rather than the umbrella PMS plan.

4. The hierarchy diagram (mermaid, inserted on both umbrella documents)

5. What a BSI auditor sees after the refactor

Opening the exported PDF of legit-health-version-2-1/post-market-surveillance/:

1. Umbrella PMS Plan (R-TF-007-005) — titled "Post-market surveillance plan". States clearly: this is the legacy-device umbrella Plan under MDD Annex II / V, with Article 83–88 obligations applied via MDR Article 120(3). Lists the four surveillance streams. Embeds the hierarchy diagram. Names R-TF-007-003 as its paired Report and R-TF-015-012 as the supplementary study Protocol whose proactive output it plans.
2. Umbrella PMS Report (R-TF-007-003) — titled "Post-market surveillance report". Role header explicitly states: this is the umbrella Article 85 report; its companion Plan is R-TF-007-005; the proactive surveillance stream this Report summarises is delivered by R-TF-015-012. Hierarchy diagram repeated.
3. Study-specific Protocol (R-TF-015-012) — titled "Cross-sectional observational study — Protocol". Role header states: this is the study-specific Protocol for the supplementary cross-sectional observational study, nested inside the umbrella Plan R-TF-007-005. The Rank 4 classification under MDCG 2020-6 Appendix III remains intact.
4. Study-specific Report — titled "Cross-sectional observational study — Report (Appendix D to R-TF-015-012)". Role header states: this is the study-specific Report, nested inside the umbrella Report R-TF-007-003.
5. Appendices A and B — unchanged; their filenames already make their role obvious.

No ambiguity. No need for internal knowledge. Every document declares its parent and child in its own opening paragraphs.

6. Interaction with task-3b8

Task-3b8 refines the "safety confirmation" column definitions in the CEP Evidence hierarchy table. Task-3b10 (this task) applies first, updating the row-anchor names (legacy umbrella Plan, legacy umbrella Report, study-specific Protocol, study-specific Report) so that task-3b8 operates on the correct row labels. The two tasks do not collide on column definitions; they collide only on row identity, which this file resolves.

7. Interaction with task-3b9

Task-3b9 routes legacy-post-market conclusions into the Plus PMS / PMCF Plan. Its audit-visible edits cite the umbrella legacy PMS Report (R-TF-007-003) and the legacy study-specific Report as its inputs. After task-3b10 lands, those citations need no re-work — the R-numbers are unchanged; only filenames and role-statements shift, and cross-references are written against R-numbers, not filenames.

8. Open items (post-submission)

• Coherent re-numbering of the legacy R-TF-015-* slot. Today R-TF-015-012 sits inside the Plus CE-marking CE series; semantically it is a legacy-device document. Full re-numbering into a dedicated legacy document-ID scheme is deferred per the task CLAUDE.md.
• Fix the pre-existing R-TF-007-003 collision between the deprecated Plus 2023 PSUR slot and the legacy umbrella PMS Report. Deferred.

9. Collisions resolved in this refactor

• R-TF-007-005 collision (resolved 2026-04-20): on first pass this file claimed the 005 slot was "free" when in fact it was still held by the Plus others/R-TF-007-005-Post-Market-Clinical-Follow-up-PMCF-Report.mdx stub and was named in the Plus STED as "R-TF-007-005 PMCF Evaluation Report". Resolution: the stub was git mvd to post-market-surveillance/deprecated/ (it was a dormant Feb-2025 template and the Plus device is pre-MDR-CE-mark so no PMCF data exists yet); the others/ folder, now empty, was removed; the Plus STED PMCF Evaluation Report slot was re-bound to R-TF-007-006; and the STED now also lists the new legacy umbrella PMS Plan (R-TF-007-005) as a distinct subsection parallel to the legacy PMS Report (R-TF-007-003).