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) mapped Annex III 1(b) requirements to procedure codes (e.g., "GP-007", "GP-004") but did not cite specific section headings 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	### Data analysis procedure: systematic compilation from seven data sources; statistical and comparison techniques; 25% threshold for trend detection; integration with risk management; documentation in T-020-001 Trend report
2	Indicators and threshold values for B/R reassessment	R-TF-007-001 PMS Plan, § Trend analysis; GP-020 threshold (25% change); R-TF-007-002 PMCF Plan, § Specific PMCF Methods, Activity C.1: Image-based diagnosis non-interventional performance analysis	Trend analysis triggers formal investigation and CAPA escalation when statistically significant increases are detected; PMCF defines explicit acceptance criteria: AUC > 0.8; Top-5 >= 70%; Top-3 >= 55%; Top-1 >= 40%
3	Methods to investigate complaints per Art. 87	GP-014 Feedback and complaints	### Information coming from customers; ### Customer complaint management; #### Customer complaint investigation and evaluation: centralised complaint intake, criticality assessment, complaint investigation, incident evaluation, and escalation to GP-004
4	Methods for trend reporting per Art. 88	GP-004 Vigilance system; GP-020 Data analysis	GP-004, ### Trend report; GP-020, ### Data analysis procedure; PMS Plan § Trend analysis
5	Methods to communicate with relevant bodies	GP-004 Vigilance system	### Notification to Regulatory Authorities; #### Timelines for initial communication of incidents; ### Field Safety Corrective Action (FSCA); #### Field Safety Notice (FSN)
6	Procedures for Art. 83 and 86	GP-007 Post-market surveillance	### Post-market surveillance system; #### Post-market surveillance (PMS) plan; #### Periodic Safety Update Report (PSUR)
7	Procedures for corrective actions and device tracing	GP-006 Non-conformities, Corrective and preventive actions; GP-016 Traceability and identification; SP-004-001 Product withdrawal	GP-006, ### Reception of Non-conformity; ### Corrective and Preventive Actions (CAPA); ### Verification of the efficacy of CAPAs; GP-016, ### Traceability; ### Product serial number and UDI assignment; SP-004-001, ### Procedure

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 and cite the exact PMCF acceptance criteria wording	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 should cite the exact GP-020 heading and explicitly identify the observation period and escalation path	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, § Data analysis procedure (statistical and comparison techniques, 25% trend threshold)
Indicators and threshold values	PMS Plan, section Trend analysis	R-TF-007-001, § Indicators and threshold values for benefit-risk reassessment; § Trend analysis; R-TF-007-002 PMCF Plan, § Specific PMCF Methods, Activity C.1, Acceptance Criteria
Methods to investigate complaints (Art. 87)	GP-014 Feedback and complaints	GP-014, § Information coming from customers; § Customer complaint management; § Customer complaint investigation and evaluation
Trend report methods (Art. 88)	PMS Plan, section Trend analysis	GP-004, § Trend report; GP-020, § Data analysis procedure; R-TF-007-001, § Trend analysis
Communication with authorities	GP-004 Vigilance system	GP-004, § Notification to Regulatory Authorities; § Timelines for initial communication of incidents; § Field Safety Corrective Action (FSCA); § Field Safety Notice (FSN)
Art. 83, 84, 86 procedures	GP-007 Post-market surveillance	GP-007, § Post-market surveillance system; § Post-market surveillance (PMS) plan; § Periodic Safety Update Report (PSUR)
Corrective actions	GP-006 CAPA	GP-006, § Reception of Non-conformity; § Corrective and Preventive Actions (CAPA); § Verification of the efficacy of CAPAs
Device tracing	GP-006; SP-004-001; GP-016	GP-016, § Traceability; § Product serial number and UDI assignment; SP-004-001, § Procedure

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 Data analysis, ### Data analysis procedure, which defines the 25% increase threshold used for formal trend investigation
• R-TF-007-002 PMCF Plan, § Specific PMCF Methods, Activity C.1: Image-based diagnosis non-interventional performance analysis, which defines the Acceptance Criteria AUC > 0.8; Top-5 >= 70%; Top-3 >= 55%; Top-1 >= 40%
• Incident rate monitoring criteria
• B/R reassessment trigger criteria

Fix 4: Add a dedicated "Trend analysis" heading

The existing trend-analysis content should sit under a clearly labelled Trend analysis heading so that the traceability table points to an exact heading name that BSI can find in the PDF.

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 the exact SOP heading where that obligation is implemented. 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: manufacturer becomes aware of a serious incident	GP-004 § Criteria to notify an incident to the national competent authorities
Art. 87(2)	Reporting timelines: 15 days, 10 days, and 2 days	GP-004 § Timelines for initial communication of incidents
Art. 87(7)	Content requirements for the manufacturer's report	GP-004 § Notification to Regulatory Authorities
Art. 87(8)	Follow-up reporting when the investigation exceeds the initial reporting period	GP-004 § Incidents occurred in Spain
Art. 87(9)	Final reporting of investigation results and actions	GP-004 § Notification to Regulatory Authorities
Art. 87(11)	Field safety corrective actions and notices	GP-004 § Field Safety Corrective Action (FSCA); GP-004 § Field Safety Notice (FSN)

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.