Prose draft — umbrella legacy PMS Plan (R-TF-007-005)

This is the internal working draft for the new umbrella PMS Plan document. It will be rendered verbatim into apps/qms/docs/legit-health-version-2-1/post-market-surveillance/r-tf-007-005-legacy-pms-plan.mdx. The prose is kept deliberately concise — the supplementary-study detail lives in R-TF-015-012; the umbrella Plan states what streams exist and how they are coordinated, not the statistical analysis plan of any single stream.

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title: "R-TF-007-005 Post-Market Surveillance Plan — Legacy device"
hide_table_of_contents: true
---

# 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: legacy device, Class I under MDD 93/42/EEC, 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 all proactive and passive surveillance streams, 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`. See the hierarchy diagram below.

## 1. Scope and regulatory basis

### 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).

### 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. 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** — the manufacturer's internal PMS procedure.
- **GP-014 Feedback and complaints** — the manufacturer's internal complaints procedure.
- **GP-004 Vigilance system** — the manufacturer's internal vigilance procedure.

### 1.3 Paired documents

| Role                                                   | Document                           |
| ------------------------------------------------------ | ---------------------------------- |
| 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`) | `questionnaire.mdx` in this folder |
| Cover letter (Appendix A to `R-TF-015-012`)            | `cover-letter.mdx` in this folder  |

### 1.4 Hierarchy diagram

```mermaid
flowchart TB
    classDef umbrella fill:#e0e7ff,stroke:#4338ca,color:#1e1b4b,stroke-width:2px
    classDef study fill:#fef3c7,stroke:#d97706,color:#7c2d12
    classDef appendix fill:#f3f4f6,stroke:#6b7280,color:#111827
    classDef downstream fill:#dcfce7,stroke:#059669,color:#064e3b

    PLAN["R-TF-007-005<br/>Legacy PMS Plan<br/>(umbrella)"]:::umbrella
    REPORT["R-TF-007-003<br/>Legacy PMS Report<br/>(umbrella)"]:::umbrella
    STUDY_P["R-TF-015-012<br/>Cross-sectional observational study<br/>— Protocol"]:::study
    STUDY_R["Appendix D to R-TF-015-012<br/>— Study Report"]:::study
    Q["Appendix B to R-TF-015-012<br/>Physician questionnaire"]:::appendix
    CL["Appendix A to R-TF-015-012<br/>Cover letter"]:::appendix
    PLUSPMS["R-TF-007-001<br/>Plus PMS Plan (successor, MDR)"]:::downstream
    PLUSPMCF["R-TF-007-002<br/>Plus PMCF Plan (successor, MDR)"]:::downstream
    CER["R-TF-015-003<br/>Plus CER (successor, MDR)"]:::downstream

    PLAN -->|plans| REPORT
    PLAN -->|plans the proactive stream via| STUDY_P
    STUDY_P -->|delivers| STUDY_R
    STUDY_R -->|consolidated into| REPORT
    STUDY_P --- Q
    STUDY_P --- CL
    REPORT -->|input to successor PMS under MDCG 2020-6 §6.2.2| PLUSPMS
    REPORT -->|input to successor PMCF| PLUSPMCF
    STUDY_R -->|Rank 4 + Rank 8 clinical data via §6.2.2| CER
```

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.

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.

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, 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, the safety-signal thresholds, and the statistical analysis plan. The umbrella Plan cites this Protocol as the proactive surveillance stream; it does not duplicate the Protocol's content.

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 (statistical frequency/severity increase)	≥ 25 % increase in a rolling three-month window versus the baseline window (GP-020)	Formal trend report; paired CAPA; review of the risk-management file
Study-specific safety signals (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. Data flow into the successor device's clinical evaluation

The legacy device's equivalent status for the successor device under MDR Article 61(5)–(6) and MDCG 2020-5 is established in the Clinical Evaluation Plan (R-TF-015-001). Under MDCG 2020-6 §6.2.2, post-market data from this equivalent legacy device is eligible as clinical data for the successor device. 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 and its Likert professional-opinion items entered at Rank 8 per MDCG 2020-6 Appendix III.
• Flagging any indicator breach listed in §3 above 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.

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

• 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