Research and planning

Internal working document

This document is for internal use only. It contains analysis, gap identification, and response strategy for Item 5 of the BSI Clinical Review Round 1. It will not be included in the final response to BSI.

1. What BSI is asking

BSI says the PMS Plan does not clearly demonstrate how the requirements of MDR Chapter VII (Articles 83–89) and Annex III 1(a) and (b) are met. They list 7 examples of gaps:

1. SOPs with sufficient detail to assess collected data — not found
2. Specific indicators and threshold values for B/R reassessment — not found
3. Methods/tools to investigate complaints per Article 87 — not found
4. Methods for trend reporting per Article 88 — not found
5. Methods to communicate with relevant bodies — not found
6. Procedures for Articles 83 and 86 — not found
7. Systematic procedures to identify/initiate corrective actions and trace devices — not found

BSI requests traceability: map Annex III 1(b) requirements → SOPs/WIs → specific sections.

This is an observation/request, not a deficiency finding.

2. Root cause: traceability, not substance

All 7 items BSI lists are covered by existing procedures. The problem is that BSI could not find them because:

1. The PMS Plan's traceability table (R-TF-007-001, lines 40–52) maps Annex III 1(b) requirements to procedure codes (e.g., "GP-007", "GP-004") but does not cite specific sections or pages within those procedures.
2. BSI reviewed PDF exports — internal links between documents were non-functional.
3. The SOPs are spread across multiple procedures (GP-004, GP-006, GP-007, GP-014, GP-016, GP-020, SP-004-001) and their relationship to the PMS Plan is not explicitly described in a single place.

The substance is there. The traceability is not.

3. Mapping BSI's 7 concerns to existing documentation

#	BSI concern	Existing SOP	Specific section/content
1	SOPs to assess collected data	GP-020 Data analysis	Systematic compilation from 7 data sources; statistical and comparison techniques; 25% threshold for trend detection; integration with risk management; documented in T-020-001 Trend report
2	Indicators and threshold values for B/R reassessment	R-TF-007-001 PMS Plan, "Trend analysis" section (line 109); GP-020 threshold (25% change); R-TF-007-002 PMCF Plan primary endpoints (AUC >0.8, Top-5 accuracy >70%, etc.)	Trend analysis triggers CAPA when statistically significant increases detected; PMCF has specific clinical performance thresholds
3	Methods to investigate complaints per Art. 87	GP-014 Feedback and complaints	HubSpot CRM for centralised management; criticality assessment (High/Medium/Low); classification as incident per Art. 87 definition; escalation to GP-004 for serious incidents; 3-week maximum response time
4	Methods for trend reporting per Art. 88	GP-004 Vigilance system	Explicitly addresses Art. 88 in scope; trend reporting using MEDDEV 2.12-1 rev.8 Annex VII form; GP-020 trend analysis with statistical thresholds
5	Methods to communicate with relevant bodies	GP-004 Vigilance system	Detailed protocols: NCA notification within 15 days (serious incident), 10 days (death/serious deterioration), 2 days (public health threat); AEMPS electronic portal with specific contact details; Field Safety Notice procedures; notified body notification
6	Procedures for Art. 83 and 86	GP-007 Post-market surveillance (Art. 83, 84); GP-007 PSUR section (Art. 86)	GP-007 scope explicitly states coverage of Art. 83, 84, 86; PSUR prepared annually per Art. 86; structure follows MDCG 2022-21
7	Procedures for corrective actions and device tracing	GP-006 CAPA: root cause analysis (5 Whys), criticality classification, Jira workflow; GP-016 Traceability: UDI system, software version tracking; SP-004-001 Product withdrawal: step-by-step withdrawal process for API product	GP-006 has systematic NC detection → RCA → CAPA workflow; GP-016 uses UDI-DI/UDI-PI and version tracking; SP-004-001 annual simulation verified

4. Gap analysis

#	Aspect	Status	Gap	Priority
1	SOPs exist with sufficient detail	All exist — GP-004, GP-006, GP-007, GP-014, GP-016, GP-020, SP-004-001	None — substance is present	—
2	PMS Plan traceability table	Incomplete — maps to procedure codes only, no section references	Needs specific section/page references for each Annex III 1(b) requirement	High
3	Indicators and thresholds documented	Partially — GP-020 has 25% threshold; PMCF has clinical thresholds	PMS Plan should consolidate all indicators/thresholds in one place rather than scattering across documents	Medium
4	Art. 87 sub-clauses traceability	Exists in GP-004 but PMS Plan doesn't reference specific sub-clauses	PMS Plan should explicitly map Art. 87 sub-clauses 1, 2, 7, 8, 9, 11 to the relevant SOP sections	High
5	Art. 88 trending methodology	Exists in GP-020 and GP-004	PMS Plan's "Trend analysis" section (line 109) describes annual analysis but could be more specific about statistical methods	Medium

Assessment: This is a documentation traceability issue, not a substantive compliance gap. The fix is to enhance the PMS Plan's Annex III 1(b) traceability table with specific cross-references rather than creating new procedures.

5. Cross-NC connections

Clinical Review Item 3a — PMS data gap

Item 3a research identified that the CER does not integrate legacy PMS data despite 4+ years of market experience. Item 5's PMS plan improvements should include explicit reference to how legacy data feeds into the ongoing PMS system, reinforcing the CER fix.

Clinical Review Item 6 — PMCF Plan

Items 6a and 6b address the PMCF Plan specifically, which is a sub-component of the PMS system. The PMCF Plan's indicators and thresholds (R-TF-007-002, line 163) are part of the same B/R reassessment framework BSI asks about here.

6. Response strategy

The response should:

1. Acknowledge that the PMS Plan's traceability table lacked sufficient detail to allow the reviewer to navigate to the relevant SOPs
2. Provide the complete traceability mapping — for each Annex III 1(b) requirement, cite the specific procedure AND section where it is addressed
3. Confirm that the PMS Plan has been updated with an enhanced traceability table containing section-level cross-references
4. Explicitly map Art. 87 sub-clauses 1, 2, 7, 8, 9, and 11 to GP-004 and GP-014 sections
5. Not create new SOPs — the existing procedures are adequate; the gap is traceability, not substance

Fixes required (all in R-TF-007-001)

Fix 1: Enhance the Annex III 1(b) traceability table with heading-level references

Replace the current table (lines 40–52) which just lists procedure codes (e.g., "GP-007 Post-market surveillance") with references to the actual section heading titles within those procedures where the information lives. BSI needs to be able to open the procedure and navigate to the right heading.

Target mapping:

Annex III 1(b) requirement	Current reference	Should reference
Proactive/systematic data collection	GP-007 Post-market surveillance	GP-007, § Post-market surveillance system; § Active monitoring of the information received
Methods to assess collected data	GP-007 Post-market surveillance	GP-020 Data analysis, § Development (statistical and comparison techniques, 25% trend threshold)
Indicators and threshold values	PMS Plan, section Trend analysis	R-TF-007-001, § Trend analysis; R-TF-007-002 PMCF Plan, § Primary endpoints (AUC, accuracy thresholds)
Methods to investigate complaints (Art. 87)	GP-014 Feedback and complaints	GP-014, § Complaint investigation and classification; § Incident evaluation per Article 87
Trend report methods (Art. 88)	PMS Plan, section Trend analysis	GP-004, § Trend reports (Art. 88); GP-020, § Trend analysis methodology
Communication with authorities	GP-004 Vigilance system	GP-004, § Notification to National Competent Authority; § Field Safety Notice; § Notified body notification
Art. 83, 84, 86 procedures	GP-007 Post-market surveillance	GP-007, § Post-market surveillance (PMS) plan (Art. 83, 84); § Planned PSUR section (Art. 86)
Corrective actions	GP-006 CAPA	GP-006, § Root cause analysis (5 Whys); § Corrective action implementation; § CAPA effectiveness verification
Device tracing	GP-006; SP-004-001; GP-016	GP-016, § UDI system and software version tracking; SP-004-001, § Product withdrawal process

Fix 2: Remove backtick/link formatting throughout R-TF-007-001

All references to other documents currently use backtick code formatting (e.g., `GP-004 Vigilance system`). Since BSI reviews PDF exports, these render as monospace code text with no navigation value. Replace with plain text references throughout the document.

Fix 3: Add a dedicated "Indicators and threshold values" section

Currently, the indicators and thresholds are scattered. Add a dedicated section to R-TF-007-001 consolidating:

• GP-020's 25% change threshold for trend detection
• PMCF clinical performance thresholds (AUC >0.8, Top-5 accuracy >70%, Top-3 accuracy >55%, Top-1 accuracy >40%)
• Incident rate monitoring criteria
• B/R reassessment trigger criteria

Fix 4: Add a dedicated "Trend analysis" heading

Line 109 describes trend analysis methodology but it's nested under the generic "Analyse trends..." heading. BSI's traceability table references "section Trend analysis" — ensure this exists as a clearly labelled top-level section.

7. Risk assessment

Risk	Impact	Mitigation
BSI may ask for more SOP detail beyond what exists	Low — the procedures are comprehensive when read in full	Provide section-level references so BSI can verify
BSI may view the existing trend analysis methodology as insufficiently statistical	Medium — GP-020's "25% threshold" is simple	Argue proportionality: device has low incident volume; more complex statistical methods are planned for PMCF phase
BSI may note that the PMS Plan references "Trend analysis section" which doesn't exist as a separate heading	Low — trend analysis is described in line 109	Update the PMS Plan to add a clearly labelled "Trend analysis" heading

8. Open items

None — all information needed to respond to Item 5 is available in existing QMS procedures. The fix is straightforward: enhance the traceability table in the PMS Plan and provide the mapping in the response.

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Regulatory framework: what the BSI meeting revealed

Severity warning

Nick stated during the BSI meeting (2026-03-25) that refusal is extremely likely if gaps are not closed, and that BSI has a policy of allowing only one round of clarification. Item 5 is not the highest-severity item, but Nick's overarching message applies: the PMS Plan is assessed under CEAR Section F, which is a blocking section. An incomplete Section F prevents certification regardless of how strong the clinical data is.

The four applicable guidance documents

Document	Role for Item 5
MDR Articles 83–89 and Annex III	The binding regulatory requirements for the PMS system. BSI's 7 concerns map directly to gaps between the PMS Plan's cross-references and these specific articles. Article 87 covers complaint investigations. Article 88 covers trend reporting. Article 83 covers the general PMS obligation. Article 86 covers PSUR frequency. The PMS Plan must be traceable to each article — not just to procedure codes, but to the specific sections within those procedures where compliance is demonstrated.
MDR Article 2(48)	Defines "clinical data." Explicitly includes "safety or performance information generated from PMS" as clinical data. This is not administrative context — it is the regulatory basis for why PMS data must feed back into the clinical evaluation (Item 3a's critical gap). The PMS Plan must be credible as the infrastructure that collects clinical data, not merely as a compliance document. If BSI cannot follow the PMS Plan's references to actual SOP sections, they cannot assess whether clinical data collection is adequate.
MDCG 2020-6, § 6.4	"No reliance on future PMCF to fill pre-certification gaps: sufficient clinical evidence must exist PRIOR to MDR certification. PMCF under MDR can confirm conclusions already supported by evidence." This means the PMS system must be demonstrably functional and complete NOW — not aspirational. A PMS Plan with procedure references that cannot be traced to specific sections is not a complete PMS system from BSI's perspective.
MEDDEV 2.7.1 Rev 4, Stage 4	The MEDDEV clinical evaluation process has four stages. Stage 4 is continuous monitoring and CER updating — driven by the PMS system. Nick stated: "Unless you complete stages 0, 1, 2, 3, 4, 5 — they won't work and it will fall down." Stage 4 is the PMS stage. BSI will assess whether the PMS Plan can plausibly deliver the Stage 4 data needed to keep the CER current. The traceability fix for Item 5 is therefore not just about demonstrating Article 83–89 compliance — it is about demonstrating that the Stage 4 mechanism is operational.
MDCG 2020-13, Section F	BSI's CEAR template explicitly checks: "PMS Plan, PMS Report, PMCF Plan, PMCF Report, PSUR reviewed; PMCF adequacy or absence justification; CER update schedule." The PMS Plan is directly audited against Section F. Any gap in the PMS Plan's traceability to the SOPs that implement Articles 83–89 will appear as a Section F non-conformity.

What the meeting revealed: the narration pattern

The pattern Nick identified for the clinical data (work done, not narrated) applies equally to the PMS Plan. All 7 SOPs that BSI could not find are present in the QMS — GP-004, GP-006, GP-007, GP-014, GP-016, GP-020, SP-004-001. The gap is that the PMS Plan does not guide the reader from "Article 87 sub-clause 1" to "GP-014 § Complaint investigation and classification." BSI cannot follow this chain without explicit section-level pointers.

Nick's specific comment about occurrence rates in the risk discussion (Item 7) reinforces this: data in the QMS must be traceable to its source. The same principle applies here: the PMS traceability table must not reference procedure names — it must reference the specific sections where Article compliance is demonstrated.

The Article 87 sub-clause mapping: explicit, not implicit

BSI's concern #3 (methods to investigate complaints per Article 87) and concern #4 (trend reporting per Article 88) require specific sub-clause mapping — not just "see GP-014." Article 87 has multiple sub-clauses that impose specific obligations:

Article 87 sub-clause	Obligation	SOP section that addresses it
Art. 87(1)	Reportability threshold: "became aware of" a serious incident	GP-014 § Incident evaluation per Article 87
Art. 87(2)	Reporting timelines: 15 days (serious), 10 days (death/serious deterioration), 2 days (public health)	GP-004 § Notification to National Competent Authority
Art. 87(7)	Analysis of incidents for trends	GP-020 § Trend analysis methodology; GP-004 § Trend reports
Art. 87(8)	Trend reporting using Article 88 methods	GP-004 § Trend reports (Art. 88)
Art. 87(9)	Communication with other relevant manufacturers	GP-004 (where applicable)
Art. 87(11)	Field safety corrective actions	SP-004-001 § Product withdrawal process

This mapping must appear explicitly in the PMS Plan's traceability table — not as a narrative, but as a directly verifiable cross-reference. BSI will look for it.

What remains unchanged

The root cause analysis (traceability, not substance) is correct. The fixes required (enhance traceability table, add heading-level references, remove backtick formatting, add indicators section) are the right interventions. The additional regulatory context from the meeting does not change the fix strategy — it confirms that the fix is necessary and explains WHY BSI cannot accept the current format.