Housekeeping — collect Céline Fabre's CV + signed Declaration of Potential Conflict of Interest for Annex I

Status (2026-04-21): Internal-only. Tracks the residual administrative work required to fully close Option A of task-3b15. Not referenced from any audit-visible document.

What was shipped today

Option A of task-3b15 landed on 2026-04-21. Two audit-visible edits were applied:

• R-TF-015-001 (CEP): a new ### External methodological review subsection inserted under ## Responsibilities: competence of the clinical evaluation team, between ### MEDDEV 2.7/1 Rev 4 §6.4 four-competence coverage and ### Subject Matter Expert coverage across the indication scope. The subsection names Horiana (Health Data Consulting) as the external consultancy, names Céline Fabre as the review lead, records the 17 April 2026 delivery and the 20 April 2026 follow-up alignment call, and scopes the review against MDCG 2020-1, MDCG 2020-6 Appendix III and MEDDEV 2.7/1 Rev 4.
• R-TF-015-003 (CER): the mirror ### External methodological review subsection inserted under ## Qualification of the responsible evaluators, between the four-member competence-matrix table and ### Subject Matter Expert coverage across the indication scope.

The factual content of both subsections is fully supported by the Horiana deliverables already on file:

• resources/_celines-feedback/2026-04-17-horiana-methodological-expertise.pdf (19 pages, V1.0, 2026-04-17).
• resources/_celines-feedback/2026-04-17-horiana-recommendations.pdf (7 pages, V1.0, 2026-04-17).
• resources/_celines-feedback/2026-04-17-email-from-horiana.md (Fabienne Diaz cover email delivering both documents).
• resources/_celines-feedback/2026-04-20-horiana-followup-call-notes.md (2026-04-20 call transcript with Céline Fabre, Coralie Cantarel, Fabienne Diaz and Antoine Giraud).

Neither subsection references Annex I, a CV, or a Declaration of Conflict of Interest. The audit-visible prose does not promise material that is not yet on file, so there is no self-inconsistency bug of the kind that task-3b11 closed for the legacy "consultation network" clause.

What is still pending (internal-only)

Two administrative artefacts remain to be collected from Horiana before Annex I can be brought into full alignment with the new body text:

1. Céline Fabre's CV (as the named external methodological review lead).
2. Signed Declaration of Potential Conflict of Interest from Céline Fabre on the review delivered 17 April 2026.

Neither artefact is required for today's Round 1 submission to BSI — the Round 1 response relies on the CEP and CER body text, not on Annex I attachments for the external reviewer. Nothing in the current audit-visible prose commits to these attachments being already in Annex I.

What to do once the CV and DoI are received

The two artefacts are collected directly from Horiana by the internal point of contact for the engagement (Saray Ugidos per the 2026-04-17 email thread).

Once both are on file:

1. Add to the Annex I package of both R-TF-015-001 and R-TF-015-003 (CV and DoI for Céline Fabre, alongside the existing four internal team members).
2. Append one sentence to the final paragraph of the ### External methodological review subsection in both documents: "The reviewer's CV and signed Declaration of Potential Conflict of Interest are provided in Annex I." The sentence only gets added once Annex I actually contains the materials — not before.
3. Record the update as a minor CEP / CER revision in the next scheduled technical-file pass.

Known Round-2 contingency raised by the reviewer pass

The bsi-clinical-auditor agent ran against the two new subsections on 2026-04-21 and returned one structured warning that is deliberately not addressed in the audit-visible body text per the user's instruction of 2026-04-21 not to mention any pending administrative gap in the CEP / CER:

• Warning: the body text is silent on where the external reviewer's CV and Declaration of Potential Conflict of Interest are filed. A close-reading BSI auditor (Erin) could ask "where do I find Céline Fabre's CV and DoI?". Silence reads as absence.
• Why it was left in place: the task-3b11 guardrail is that the body text must not promise Annex I content that is not yet there. Until the CV + DoI are collected, the defensible posture is silence in the body text rather than a forward promise we cannot back. Adding a vague engagement-records sentence to paper over the gap is worse than holding silence, because it invites a direct follow-up question and starts a paper trail we then have to defend.
• How it gets closed: once the CV + DoI are on file in Annex I (step 1 of the "What to do" section above), the body-text sentence referenced in step 2 closes the gap in a single pass. If BSI raises the CV location in Round 2 before that happens, the Round-2 response attaches the materials and points at them directly; no Round-1 regression results.

The celine-clinical-consultant agent also returned one must-fix on the first version of the subsections (scope-boundary drift — the first draft implied Céline had reviewed the full current evidence set including MAN_2025 and R-TF-015-012, which were outside her 2026-04-17 cut-off). That must-fix was applied on the same day before task closure: the subsections now explicitly scope the external review to "the nine completed clinical investigations that were available at the 17 April 2026 review cut-off" and explicitly flag MAN_2025 and R-TF-015-012 as outside the external review sample with their appraisal attributed to the named evaluation team.

Guardrails

• Do not add the "see Annex I" sentence to the audit-visible text until the CV and DoI are physically in Annex I. Repeating the task-3b11 self-inconsistency bug would be a regression.
• Do not mention in any audit-visible document that CV / DoI collection is pending, scheduled, or "to follow". The audit-visible prose describes a complete external review that happened and whose deliverables are retained in the QMS — which is true — without committing to administrative attachments that are not yet in place.
• Do not escalate this to a Round-1 submission blocker. Collection is administrative housekeeping; the Round-1 response does not depend on it.
• Do not extend the Horiana description in the CEP / CER beyond what the deliverables support. Horiana is a consultancy engagement with a scoped methodological review; it is not a standing clinical-evaluation team member and must not be framed as one.

Ownership

• Saray Ugidos (or whichever internal point of contact handles the Horiana relationship): collects Céline Fabre's CV and signed Declaration of Potential Conflict of Interest.
• Claude (on request, in a separate session): once the artefacts are on file, appends the Annex I sentence to the ### External methodological review subsection in R-TF-015-001 and R-TF-015-003, updates the Annex I attachment list accordingly, and runs the three-agent reviewer pass on the final result.

Cross-references

• Task folder: task-3b15-sme-coverage-subspecialty-consultants-round2/ (this folder).
• Scoping decision: do-we-need-this.md in this folder — the 2026-04-21 memo that narrowed task-3b15 to Option A only.
• External-review source material: resources/_celines-feedback/ (Horiana deliverables and call notes).
• Related closed task: completed-tasks/task-3b11-sme-coverage-subspecialty-documentation/ — the Option D-lite structured subspecialty-coverage table remains in place and is unaffected by the Option A edits.