Response

The PMS Plan (R-TF-007-001) contained a traceability table mapping Annex III 1(b) requirements to the applicable quality management procedures. However, the table referenced procedures only by their document code and title without citing the specific section headings within those procedures where each requirement is substantively addressed. Additionally, the document lacked a dedicated section consolidating the specific indicators and threshold values used for benefit-risk reassessment, and did not include sub-clause level traceability for Articles 83, 86, 87, and 88 or for Annex XIV.

The PMS Plan has been updated to address all of these gaps. The specific changes are described below. Red-lined documentation is provided.

1. Enhanced Annex III 1(b) traceability table

The Annex III 1(b) traceability table now references the specific section headings within each procedure where the relevant content is documented:

• Proactive and systematic data collection: GP-007 Post-market surveillance, § Post-market surveillance system; § Active monitoring of the information received
• Methods to assess collected data: GP-020 Data analysis, § Data analysis procedure
• Indicators and threshold values for benefit-risk reassessment: R-TF-007-001 Post-Market Surveillance (PMS) Plan, § Indicators and threshold values for benefit-risk reassessment; § Analyse trends, decide on necessary measures and implement them; R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan, § Specific PMCF Methods
• Methods to investigate complaints (Article 87): GP-014 Feedback and complaints, § Customer complaint management; § Information coming from customers
• Trend report methods (Article 88): GP-004 Vigilance system, § Trend report; GP-020 Data analysis, § Data analysis procedure; R-TF-007-001 PMS Plan, § Analyse trends, decide on necessary measures and implement them
• Communication with competent authorities, notified bodies and users: GP-004 Vigilance system, § Notification to Regulatory Authorities; § Field Safety Corrective Action (FSCA); § Criteria to notify an incident
• Procedures for Articles 83, 84 and 86: GP-007 Post-market surveillance, § Post-market surveillance (PMS) plan; § Periodic Safety Update Report (PSUR)
• Corrective actions: GP-006 Non-conformities, Corrective and preventive actions, § Reception of Non-conformity; § Corrective and Preventive Actions (CAPA); § Verification of the efficacy of CAPAs
• Device tracing: GP-016 Traceability and identification, § Traceability; § Product serial number and UDI assignment; SP-004-001 Product withdrawal, § Procedure

2. Specific indicators and threshold values for benefit-risk reassessment

A new dedicated section "Indicators and threshold values for benefit-risk reassessment" has been added to R-TF-007-001. This section consolidates all specific indicators and threshold values used in the continuous reassessment of the benefit-risk analysis:

• Trend detection threshold: A 25% increase over historic or foreseeable data triggers a formal investigation, as defined in GP-020 Data analysis, § Data analysis procedure. Trends are registered as a T-020-001 Trend report or a T-006-001 Non-conformity report with root cause analysis and corrective actions.
• Clinical performance thresholds (PMCF): AUC higher than 0.8, Top-5 diagnostic accuracy higher than 70%, Top-3 accuracy higher than 55%, Top-1 accuracy higher than 40%, as defined in R-TF-007-002 PMCF Plan, § Specific PMCF Methods, Activity C.1. Sustained performance below any threshold triggers a benefit-risk reassessment.
• Severity assessment agreement: Measured using the Interobserver Correlation Coefficient (ICC) per R-TF-007-002 PMCF Plan, Activities B.1–B.4.
• Quality indicators: Established in T-002-002 Quality objectives and T-002-003 Quality indicators, reviewed quarterly and compared against expected values at each annual management review.
• Benefit-risk reassessment triggers: Defined criteria for initiating a reassessment, including threshold exceedance, performance below PMCF thresholds, identification of new risks, statistically significant increase in incident frequency or severity, and contradictory clinical evidence.

3. Trend analysis methodology — observation period and statistical methods (Article 88)

The "Analyse trends, decide on necessary measures and implement them" section in R-TF-007-001 has been expanded with three new sub-sections:

• Observation period: The primary observation period is annual, aligned with the PSUR cycle. Quality indicators are reviewed quarterly to enable early detection. Multi-year comparisons are performed at each annual management review.
• Statistical methods and threshold for statistically significant increase: Statistical and comparison techniques are used per GP-020 Data analysis, § Data analysis procedure. A 25% increase over historic or foreseeable data constitutes the threshold for a statistically significant increase, as required by Article 88.
• Escalation and reporting: Non-conformity reports and CAPA initiation per GP-006; trend reports submitted to the NCA using MEDDEV 2.12-1 rev.8 Annex VII form per GP-004 Vigilance system, § Trend report.

4. Article 87 sub-clause level traceability

A new section "Article 87 — Reporting of serious incidents and field safety corrective actions" has been added to R-TF-007-001, § Detailed regulatory traceability, providing sub-clause level mapping for the six sub-clauses referenced in the observation:

• Article 87(1): Serious incident reporting obligation — GP-004 Vigilance system, § Criteria to notify an incident to the national competent authorities.
• Article 87(2): Reporting timeframes (15/10/2 calendar days) — GP-004 Vigilance system, § Timelines for initial communication of incidents.
• Article 87(7): Manufacturer report content (MIR format per MEDDEV 2.12-1 rev.8) — GP-004 Vigilance system, § Notification to Regulatory Authorities.
• Article 87(8): Follow-up reports — GP-004 Vigilance system, § Incidents occurred in Spain.
• Article 87(9): Final report with investigation results and actions — GP-004 Vigilance system, § Notification to Regulatory Authorities.
• Article 87(11): FSCAs and FSNs — GP-004 Vigilance system, § Field Safety Corrective Action (FSCA); § Field Safety Notice (FSN).

5. Articles 83 and 86 sub-clause level traceability

New sections for Articles 83 and 86 have been added to R-TF-007-001, § Detailed regulatory traceability:

Article 83:

• 83(1): PMS system establishment — R-TF-007-001 and GP-007, § Post-market surveillance system.
• 83(2): Active and systematic data gathering — GP-007, § Post-market surveillance system; GP-020, § Data analysis procedure.
• 83(3): PMS plan as part of technical documentation — R-TF-007-001 is included in the technical documentation.
• 83(4): Data availability to competent authorities — GP-004, § Notification to Regulatory Authorities; GP-007, § Periodic Safety Update Report (PSUR).

Article 86:

• 86(1): PSUR content and preparation — GP-007, § Periodic Safety Update Report (PSUR); structure follows MDCG 2022-21.
• 86(2): Annual update for class IIb — confirmed in R-TF-007-001, § Planned PSUR.

6. Annex XIV traceability

A new section "Annex XIV — Clinical evaluation and post-market clinical follow-up" has been added to R-TF-007-001, § Detailed regulatory traceability, covering both Part A and Part B:

Annex XIV Part A (Clinical evaluation):

• Clinical literature is reviewed annually as part of PMS activities, and results feed into the clinical evaluation per GP-015 Clinical evaluation.
• All relevant PMS and PMCF findings are systematically incorporated into the T-015-003 Clinical Evaluation Report.
• PMS data is compared with previous clinical data per GP-020 Data analysis, § Data analysis procedure and GP-015 Clinical evaluation.

Annex XIV Part B (Post-market clinical follow-up):

• The PMCF plan (R-TF-007-002) has been developed in accordance with Annex XIV Part B. The PMCF evaluation report is prepared in accordance with Article 86 and Annex XIV Part B, Section 5.

Summary

All seven concerns raised in the original observation are addressed by existing quality management procedures. No new procedures were required. The gaps were in (a) the traceability mapping within the PMS Plan, which has been corrected with section-heading level references, (b) the absence of a dedicated section consolidating indicators and threshold values, which has been added, and (c) the absence of sub-clause level traceability for Articles 83, 86, 87, 88, and Annex XIV, which has been added as a dedicated regulatory traceability section.

Relevant commits

• 54a827183 (2026-03-08, Taig Mac Carthy): Updated R-TF-007-001 Post-Market Surveillance (PMS) Plan. Expanded "Analyse trends" section with observation period (annual/quarterly), statistical methods (25% threshold from GP-020), and escalation procedures. Added new "Indicators and threshold values for benefit-risk reassessment" section consolidating trend detection threshold, PMCF clinical performance thresholds (AUC, Top-N accuracy), severity assessment agreement (ICC), quality indicators, and benefit-risk reassessment triggers. Added new "Detailed regulatory traceability" section with sub-clause mappings for Articles 83(1–4), 86(1–2), 87(1,2,7,8,9,11), 88, and Annex XIV Parts A and B. Updated Annex III 1(b) traceability table to reference the new indicators section.