Message for Jordi: PMCF Plan Section D needed

BLOCKER — Item 6 responses describe PMCF activities that do not exist

The Item 6a and 6b responses (ra-pmcf-activity-descriptions/response.mdx and rb-pmcf-data-sufficiency-justification/response.mdx) say "We have implemented a comprehensive update" and describe 11 activities (A.1 through D.2), including two new activities D.1 and D.2 for autoimmune and genodermatoses evidence gaps. Section D does not exist in the actual PMCF plan. The CER also forward-references these activities in three places. If we submit without adding them, BSI will check and find nothing.

Deadline: 2026-04-21

What BSI asked

BSI raised two concerns about the PMCF plan (deficiency finding):

1. Item 6a: The PMCF plan has many activities but lacks sufficient detail (rationale, methodology, sample size, acceptance criteria, timelines) and traceability to specific gaps. Some activities reference "teledermatology" without clarification. An evaluation of equivalent/similar devices is not found.

2. Item 6b: Overall justification that the PMCF plan will collect sufficient data to confirm benefit, safety, and performance over the device's lifetime is not found.

What the responses promise

The Item 6a response says all 11 activities (A.1 through D.2) have been expanded with full descriptions including rationale, methodology, sample size, acceptance criteria, and timelines. It specifically says "two new activities (D.1 and D.2) addressing the evidence coverage gaps declared in the CER per MDCG 2020-6 § 6.5(e)."

The Item 6b response says coverage mapping now includes "both declared evidence coverage gaps per MDCG 2020-6 § 6.5(e): Gap 4 (autoimmune diseases) addressed by Activity D.1, and Gap 5 (genodermatoses) addressed by Activity D.2."

What the actual PMCF plan contains (the problem)

The file R-TF-007-002-Post-Market-Clinical-Follow-up-PMCF-Plan.mdx is 300 lines long and contains:

What EXISTS (verified):

• Gaps 1, 2, 3 (Triage, Severity Assessment, Algorithmic Stability)
• Activities A.1 through C.2.3 with rationale, methodology, sample size, acceptance criteria, timelines
• Data sufficiency justification section
• Teledermatology clarification (info admonition at line 45)
• Evaluation of equivalent and similar devices section (line 94, references SkinVision, DERM, etc.)

What does NOT exist:

• No Gap 4 (autoimmune diseases) in the Specific Objectives section
• No Gap 5 (genodermatoses) in the Specific Objectives section
• No Section D header or introductory paragraph
• No Activity D.1 (prospective surveillance of autoimmune conditions)
• No Activity D.2 (passive surveillance of genodermatoses)
• No evidence gap coverage mapping in the Coverage Mapping section
• No data sufficiency paragraph for Gaps 4 and 5

Why this is critical

The CER (R-TF-015-003) already declares these gaps in three places:

1. Line 170: "Two low-prevalence categories — autoimmune diseases (~3%) and genodermatoses (~1%) — are declared as acceptable evidence gaps... addressed through targeted PMCF activities documented in R-TF-007-002."
2. Lines 1581-1583: Gap 4 and Gap 5 detailed descriptions in "Need for more clinical evidence."
3. Line 1585: "Consequently, specific activities have been designed in the Post-Market Clinical Follow-up (PMCF) Plan to address these specific objectives."

All three statements forward-reference R-TF-007-002. If BSI opens R-TF-007-002 and finds no Section D, the CER's gap declarations become unsupported — which turns "acceptable gap with PMCF" into "unsupported gap" under MDCG 2020-6 § 6.5(e).

What you need to do

Everything is specified in detail in item-0/issue-6-pmcf.mdx. That document contains the exact text, structure, and acceptance criteria for both activities. Here is the summary:

1. Add Gap 4 and Gap 5 to the Specific Objectives section

After the existing Gap 3 bullet, add:

• Gap 4: Autoimmune diseases evidence coverage. The pre-market evidence portfolio contains insufficient direct evidence for autoimmune skin conditions (3% of dermatological presentations). The gap is declared acceptable per MDCG 2020-6 § 6.5(e) and is addressed through Activity D.1.
• Gap 5: Genodermatoses evidence coverage. No genodermatoses cases appear in the pre-market clinical evidence portfolio (1% of presentations). The gap is declared acceptable per MDCG 2020-6 § 6.5(e) and is addressed through Activity D.2.

2. Add Section D after Section C

Title: D. Consolidated CER Gaps 4 and 5: Evidence Coverage for Autoimmune and Genodermatoses Conditions

Add the introductory paragraph and two activities exactly as specified in issue-6-pmcf.mdx:

Activity D.1 (Prospective surveillance of autoimmune skin condition recognition):

• Addresses CER Gap 4
• Methodology: Prospective, observational, real-world data from clinical sites. Autoimmune diagnoses confirmed by dermatologist with serological testing where indicated.
• Conditions: Bullous pemphigoid, cutaneous lupus erythematosus, dermatomyositis, morphea, pemphigus foliaceus. Note: pemphigus vulgaris contributes to Tier 2 rare diseases, not autoimmune coverage.
• Sample size: 50 confirmed autoimmune cases
• Acceptance criteria: Top-3 accuracy for autoimmune category >= 60%; safety criterion based on zero clinically significant delays; surveillance trigger if >20% of cases have correct category below Top-5
• Timeline: From CE marking, first interim at 12 months or 15 cases, target completion at 50 cases or 36 months

Activity D.2 (Passive surveillance of genodermatoses):

• Addresses CER Gap 5
• Methodology: Passive surveillance through PMS system. Active recruitment explicitly not conducted (justified by 1% prevalence and genetic-testing dependence).
• No pre-specified sample size
• Acceptance criteria: Zero cases where device output contributed to patient harm; surveillance trigger if >3 cases in 12 months with all categories below Top-5; coverage trigger at 30 cumulative cases
• Timeline: Continuous throughout device lifetime, annual review

3. Update the Coverage Mapping section

Add to the existing "Comprehensive Coverage Mapping" subsection:

Coverage of Evidence Gaps (MDCG 2020-6 § 6.5(e)):

• Gap 4 (Autoimmune diseases): Activity D.1
• Gap 5 (Genodermatoses): Activity D.2

4. Add data sufficiency paragraph for Gaps 4 and 5

Add a paragraph in the Data Sufficiency Justification section explaining that D.1 and D.2 are surveillance activities (not pre-market evidence generators) that monitor whether the CER's acceptability justifications hold in practice.

5. Update x-3 decision status

After completing the above, update the decision status in item-0/x-3-disease-categorisation.mdx — change the D.1/D.2 row from "BLOCKED" to "Done."

6. Build and verify

Run npm run build:qms and verify no errors.

Where the file lives

apps/qms/docs/legit-health-plus-version-1-1-0-0/post-market-surveillance/R-TF-007-002-Post-Market-Clinical-Follow-up-PMCF-Plan.mdx

What NOT to change

• Do NOT modify Activities A.1 through C.2.3 — they are already adequate per the verification audit.
• Do NOT change the acceptance criteria for D.1 without discussing with the team — the 60% Top-3 threshold was deliberately chosen as defensible given the difficulty of autoimmune conditions.
• The teledermatology clarification and equivalent devices sections are already present and verified — do not duplicate them.

Full specification

For the complete spec including exact wording, see item-0/issue-6-pmcf.mdx.