R-TF-007-005 Post-Market Surveillance Plan — Legit.Health version 2.1 (Legacy device)
Role of this document. This is the umbrella Post-Market Surveillance Plan for the legacy version of the device (internal reference: Legit.Health version 2.1), a Class I medical device software placed on the European market from 2020 onwards under Directive 93/42/EEC (MDD) and continued on the market under MDR Article 120(3) transitional provisions. It is the Plan at the top of the two-tier legacy post-market documentation hierarchy: it scopes every proactive and passive surveillance stream, defines indicators and threshold values for benefit-risk reassessment, and plans the production of the paired umbrella Post-Market Surveillance Report (R-TF-007-003). One proactive surveillance stream described in this Plan is delivered through a nested study-specific cross-sectional observational study, whose Protocol is held as R-TF-015-012 and whose Report is held as Appendix D to R-TF-015-012. The hierarchy of the four legacy post-market documents is illustrated in section 1.4.
1. Scope and regulatory basis
1.0 Document history and supersession
This Plan consolidates, into a single umbrella document, the procedural content previously distributed across GP-007 (Post-market surveillance), GP-014 (Feedback and complaints), GP-004 (Vigilance system), GP-005 (Non-conformity and CAPA) and GP-020 (Data analysis). The indicator thresholds in §3 have been in force since the MDR transition cycle opened for the legacy device; the consolidation into this Plan does not introduce new thresholds, but brings the existing obligations under a single named legacy-device PMS Plan so that the umbrella-Plan / umbrella-Report / study-specific-Protocol / study-specific-Report hierarchy is audit-legible from a single entry point. This Plan supersedes any predecessor PMS-planning record maintained for the legacy device under the consolidated procedures. The document is under the control-of-documents procedure (GP-001); the issue date and revision history are captured in the Signature block at the end of this document.
1.1 Device under surveillance
This Post-Market Surveillance Plan covers the legacy version of the device (internal reference: Legit.Health version 2.1), a Class I medical device software placed on the European market from 2020 onwards under Directive 93/42/EEC (MDD) Annex IX Rule 12, self-declared by the manufacturer with no notified body certificate required for Class I under MDD. The legacy device is the equivalent legacy device on which the successor device under MDR evaluation claims equivalence per MDR Article 61(4)–(5).
Across the current reporting period the legacy device is deployed under 21 institutional contracts and has generated approximately 250,000 diagnostic reports in routine clinical use.
1.2 Regulatory basis
This Plan is prepared in accordance with:
- MDR Article 83 — General obligations for post-market surveillance. The manufacturer shall plan, establish, document, implement, maintain and update a PMS system proportionate to the risk class and appropriate for the type of device; the system shall actively and systematically gather, record and analyse relevant data on the quality, performance and safety of the device throughout its lifetime. Applicable to the legacy Class I device via MDR Article 120(3).
- MDR Article 84 — Post-market surveillance plan. The PMS system shall be based on a documented plan that forms part of the technical documentation.
- MDR Article 85 — Post-market surveillance report for Class I devices.
- MDR Article 87 — Reporting of serious incidents and field safety corrective actions.
- MDR Article 88 — Trend reporting.
- MDR Article 120(3) — Transitional provisions. MDR Articles 83–100 apply in place of the corresponding MDD requirements for devices continuing on the market under MDD certificates during the transition period.
- MDR Annex III — Technical documentation on post-market surveillance.
- MDD Annex II and Annex V — Legacy post-market obligations: systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions.
- MDCG 2020-6 §6.2.2 — Post-market data from a legacy device may be used as a source of clinical data for the current device under MDR when equivalence has been demonstrated.
- ISO 13485 §8.2 — Monitoring and measurement, including feedback and complaint handling.
- GP-007 Post-market surveillance procedure.
- GP-014 Feedback and complaints procedure.
- GP-004 Vigilance system procedure.
- GP-005 Non-conformity and CAPA procedure.
1.3 Paired documents
| Role | Document identifier |
|---|---|
| Umbrella PMS Report (MDR Article 85) | R-TF-007-003 |
| Study-specific proactive study — Protocol | R-TF-015-012 |
| Study-specific proactive study — Report | Appendix D to R-TF-015-012 |
| Physician questionnaire | Appendix B to R-TF-015-012 |
| Cover letter | Appendix A to R-TF-015-012 |
| Anonymised respondent dataset (held in QMS, available for audit) | Appendix C to R-TF-015-012 |
1.4 Hierarchy diagram
2. Surveillance streams
This Plan coordinates four surveillance streams. Each stream has its own Initial Data Source Procedure (IDSP) in the QMS; each feeds aggregated findings into the paired umbrella Report (R-TF-007-003).
2.1 Passive surveillance — complaints and field feedback
Complaints, field communications and user-reported concerns are received through three channels: direct clinical and technical support lines, in-institution feedback captured during kick-off sessions, training sessions and on-site visits, and automated operational alerts from the production infrastructure escalated to the QMS registry when a customer-visible degradation is observed. All received items are logged in R-006-002 (non-conformity, claims and communications registry) per GP-014 § Information coming from customers; § Customer complaint management; § Customer complaint investigation and evaluation.
2.2 Passive surveillance — vigilance
Serious incidents (MDR Article 2(65) / Article 87) and field safety corrective actions (MDR Article 2(68) / Article 87) are monitored continuously against the MDR Article 2(64)/(65) definitions. Internal CAPAs are managed under GP-005 and are linked to the registry entries that triggered them. Notification to competent authorities follows GP-004 § Notification to Regulatory Authorities and the timelines in GP-004 § Timelines for initial communication of incidents. Field Safety Corrective Actions and Field Safety Notices follow GP-004 § Field Safety Corrective Action (FSCA) and § Field Safety Notice (FSN).
2.3 Proactive surveillance — supplementary cross-sectional observational study
A proactive post-market clinical study is planned and executed under the study-specific Protocol R-TF-015-012 (Cross-Sectional Observational Study with Retrospective Recall Evaluating the Physician-Reported Clinical Performance of the Legacy Device in Routine Clinical Practice). The study-specific Protocol owns:
- the endpoint definitions (three co-primary, six supportive, ten Likert professional-opinion, six safety);
- the MCID thresholds derived from published State of the Art;
- the Holm-Bonferroni family-wise error rate control at α = 0.05 for the three co-primary endpoints;
- the pre-specified data-source sensitivity analysis (record-consulted versus professional-estimate);
- the safety-signal thresholds (F1 ≥ 30 %, F2 ≥ 30 %, F3 mean below 3.5);
- the statistical analysis plan and the evidence-quality substantiation principle of its Section 8.4 and Section 10.7.
This umbrella Plan specifies the proactive-stream indicators and thresholds in §3; the study-specific Protocol R-TF-015-012 implements them in a defined data-collection instrument, endpoint definition, and statistical analysis plan. The study's conclusions are consolidated into the umbrella Report (R-TF-007-003) §4.7 and, under MDCG 2020-6 §6.2.2, become eligible as clinical data for the successor device's clinical evaluation.
2.4 Curated QMS data and trend analysis
The R-006-002 registry and the underlying QMS records (GP-015 management review inputs, GP-020 data analysis outputs) are reviewed at each management review cycle and whenever a new entry is added in a clinical or safety category. The review assesses whether any new entry, or any new trend across entries, triggers an MDR Article 88 trend report or an update to the risk management file (R-TF-028-*).
3. Indicators and threshold values for benefit-risk reassessment
| Indicator | Threshold | Escalation if breached |
|---|---|---|
| Article 87 serious-incident count | Any occurrence | Immediate notification under GP-004; review of risk-management file; update to umbrella Report |
| Article 88 trend threshold (statistically significant frequency/severity increase) | ≥ 25 % increase in a rolling three-month window versus the baseline window (GP-020 § Data analysis procedure) | Formal trend report; paired CAPA; review of the risk-management file |
| Study-specific safety signals (see study-specific Protocol R-TF-015-012) | Per-item thresholds pre-specified in the Protocol (F1 ≥ 30 %, F2 ≥ 30 %, F3 mean below 3.5) | Study-specific follow-up as defined in the Protocol; escalation into the umbrella Report |
| Clinical-output accuracy complaint rate | > 1 event per 100 000 reports | Paired CAPA; targeted data review; consideration of CER update |
| API-availability event rate | > 2 events per rolling 12-month window | Paired CAPA; infrastructure review |
| Any event that may require an update to the Instructions for Use, labelling, or Intended Purpose | Qualitative trigger | Unscheduled CER update per GP-015; notification to the successor-device clinical evaluation team |
4. Post-market clinical follow-up for the legacy device and data flow into the successor device
4.1 Post-market clinical follow-up for the legacy device
During the MDR Article 120(3) transition period the legacy device remains on the market under MDD certification. The proactive cross-sectional observational study planned at §2.3 and executed under the study-specific Protocol R-TF-015-012 constitutes the legacy device's post-market clinical follow-up activity for this surveillance cycle. Further legacy-device PMCF activities are not planned, on the basis that the legacy device is subject to structured successor-device PMCF (R-TF-007-002) under the MDCG 2020-5 equivalence route and to the continued passive surveillance streams described in §2.1–§2.2 and §2.4 of this Plan. This scoping is declared under MDCG 2020-6 §6.5(e) as a proportionate post-market clinical follow-up design for a legacy Class I device under Article 120(3), and is revisited at each management review cycle.
4.2 Data flow into the successor device's clinical evaluation
Provided that equivalence per MDCG 2020-5 and MDR Article 61(5)–(6) is upheld in the successor device's Clinical Evaluation Plan (R-TF-015-001) and Clinical Evaluation Report (R-TF-015-003), post-market data from this equivalent legacy device is eligible as clinical data for the successor device under MDCG 2020-6 §6.2.2. This Plan therefore commits to:
- Making the umbrella PMS Report (R-TF-007-003) available as an input document to the successor device's Plus PMS Plan (R-TF-007-001) and Plus PMCF Plan (R-TF-007-002).
- Making the study-specific Report (Appendix D to R-TF-015-012) available as an input document to the successor device's Clinical Evaluation Report (R-TF-015-003), with its quantitative endpoints entered at Rank 4 (under the MDCG 2020-6 Appendix III Rank 4 considerations column: "high quality surveys may also fall into this category") and its Likert professional-opinion items entered at Rank 8.
- Flagging any indicator breach listed in section 3 as a trigger for an unscheduled update of the successor device's clinical evaluation.
5. Reporting cadence and responsibilities
5.1 Cadence
- The paired umbrella PMS Report (R-TF-007-003) is prepared once per reporting period defined by GP-007.
- The study-specific Protocol R-TF-015-012 is re-opened for new cycles of proactive surveillance at the cadence defined in its own § Reporting cadence.
- Trend analysis of the R-006-002 registry is conducted at each management review cycle (GP-015).
5.2 Responsibilities
| Activity | Responsible role |
|---|---|
| Maintenance of this Plan | JD-004 (Quality Manager & PRRC) |
| Preparation of the paired umbrella Report | JD-004 / JD-005 |
| Execution of the study-specific Protocol | As defined in R-TF-015-012 |
| Trend analysis | JD-005 |
| Vigilance notifications | JD-004 |
| Management review inputs | JD-001 / JD-004 |
6. Deviations
No deviations from this Plan were identified during the reporting period covered by the current umbrella Report (R-TF-007-003). Any future deviation is recorded in the umbrella Report and, where applicable, triggers a paired CAPA under GP-005.
7. References
7.1 Regulatory
- MDR 2017/745 Articles 83, 84, 85, 86, 87, 88, 120(3); Annex III
- MDD 93/42/EEC Annex II; Annex V; Annex IX Rule 12
- MDCG 2020-6 §6.2.2
- MEDDEV 2.12/1 rev 8
7.2 Internal documents
- R-TF-007-001 Plus PMS Plan (successor, MDR)
- R-TF-007-002 Plus PMCF Plan (successor, MDR)
- R-TF-007-003 Legacy umbrella PMS Report
- R-TF-015-001 Plus Clinical Evaluation Plan
- R-TF-015-003 Plus Clinical Evaluation Report
- R-TF-015-012 Legacy cross-sectional observational study — Protocol (with Appendices A–D)
- R-006-002 Non-conformity, claims and communications registry
- R-TF-028-* Risk management file
- GP-007, GP-014, GP-004, GP-005, GP-015, GP-020 procedures
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
- Approver: JD-001 General Manager