R-TF-007-003 Post-Market Surveillance Report — Legit.Health version 2.1 (Legacy device)

Role of this document. This is the umbrella Post-Market Surveillance Report for the legacy version of the device, prepared per MDR Article 85 applicable to the legacy Class I device via MDR Article 120(3). It is the Report at the top of the two-tier legacy post-market documentation hierarchy: it consolidates the results and conclusions of every surveillance stream planned in the umbrella PMS Plan (R-TF-007-005) across the reporting period, combining passive surveillance (complaints, vigilance, trend analysis) with proactive surveillance (the cross-sectional observational study whose Protocol is 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 below.

Hierarchy of the legacy post-market documents

1. Scope and regulatory basis

1.1 Device under surveillance

This Post-Market Surveillance Report covers the legacy version of the device (internal reference: Legit.Health version 2.1), the equivalent legacy device on which the successor device under MDR evaluation claims equivalence per MDR Article 61(4–5). The legacy device has been placed on the European market from 2020 onwards under Directive 93/42/EEC (MDD) as a Class I medical device software (MDD Annex IX Rule 12), self-declared by the manufacturer with no notified body certificate required for Class I under MDD.

Across the reporting period, the legacy device was deployed under 21 institutional contracts and generated approximately 250,000 diagnostic reports in routine clinical use.

1.2 Reporting period

This is the first consolidated Article 85 PMS Report for the legacy device and covers the reporting period from market introduction in 2020 to the close of the current PMS cycle in Q1 2026. Preparation of the consolidated report commenced on 2025-11-07 as part of the MDR transition preparation cycle. Subsequent updates extending through the closure of the proactive surveillance study described in Section 3.3 have been incorporated into this issue.

1.3 Regulatory basis

This report is prepared in accordance with:

• MDR Article 85 — Post-market surveillance report for Class I devices. Article 85 requires manufacturers of Class I devices to prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan, together with a rationale and description of any preventive and corrective actions taken.
• MDR Article 120(3) — Transitional provisions. The MDR's post-market surveillance, market surveillance, vigilance, and registration requirements (Articles 83–100) apply to the legacy MDD Class I device in place of the corresponding MDD requirements during continued market placement under MDD. This report is therefore structured per MDR Article 85 even though the device remains on the market under MDD certification.
• MDR Article 83 — General obligations for PMS. 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 a device throughout its entire lifetime.
• MDR Article 87 — Reporting of serious incidents and field safety corrective actions.
• MDR Article 88 — Trend reporting.
• 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 Complaints handling and customer communication — the manufacturer's internal complaints procedure.

1.4 Cross-reference to the paired umbrella PMS Plan

This Report implements the umbrella Post-Market Surveillance Plan for the legacy device (R-TF-007-005). That Plan defines the four surveillance streams, the data sources, the surveillance methods, the trend thresholds, the review cadence, and the feedback loops into risk management and clinical evaluation. One proactive surveillance stream planned in R-TF-007-005 is delivered through the study-specific Protocol R-TF-015-012 (cross-sectional observational study), whose Appendix D (Study Report) is consolidated into Section 4.7 below. No deviations from the umbrella Plan were identified during the reporting period. The successor device's own Post-Market Surveillance Plan (R-TF-007-001, MDR Class IIb) and Post-Market Clinical Follow-up Plan (R-TF-007-002) consume this Report as an input under MDCG 2020-6 §6.2.2.

2. PMS activities conducted during the reporting period

The post-market surveillance activities conducted for the legacy device across the reporting period combine passive surveillance (receiving and analysing reports from users, customers, and the vigilance infrastructure) with proactive surveillance (actively soliciting post-market performance evidence under a formal study protocol). The two streams are combined here in a single consolidated report.

2.1 Passive surveillance: complaints and field feedback

Complaints, field communications, and user-reported concerns are received through three channels and routed into a single registry:

• Direct email and telephone to the manufacturer's clinical and technical support lines.
• In-institution feedback captured during kick-off sessions, training sessions, and on-site visits.
• Automated operational alerts from the production infrastructure that are escalated to the QMS registry when a customer-visible degradation is observed.

All received items are logged in the R-006-002 non-conformity, claims and communications registry. The registry has been maintained in its current structured format from 2022-09-22 onwards; prior entries (2020–September 2022) were captured in a predecessor format that was migrated into the current registry at the point of structural changeover.

2.2 Passive surveillance: vigilance (incidents, FSCAs, CAPAs)

Serious incidents (MDR Article 87) and field safety corrective actions are monitored continuously against the Article 2(64)/2(65) definitions. Internal CAPAs are managed under GP-005 and are linked to the registry entries that triggered them.

2.3 Proactive surveillance: cross-sectional observational study (R-TF-015-012)

A proactive post-market clinical study was conducted 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) nested inside the umbrella PMS Plan (R-TF-007-005), to evaluate whether the legacy device achieves its three declared clinical benefits in routine clinical practice, and to quantify the magnitude of benefit relative to pre-specified Minimum Clinically Important Difference (MCID) thresholds and published State of the Art (SotA) baselines. The study used a structured physician questionnaire as its data collection instrument, was distributed by cover letter to all 21 legacy device client institutions on 2026-03-23, and closed on 2026-04-13 with 60 responses collected. Under the protocol's evidence-quality substantiation principle (Section 10.7, extending the Section 8.4 principle to Section F safety responses), four responses were excluded as unsubstantiated safety flags (see the companion study report, "Data-quality exclusions"), yielding an analysis set of N = 56, still exceeding the stretch target of 45.

The study's methodology and full results are documented in the companion Study Report (Appendix D to R-TF-015-012). A summary of the results is presented in Section 4.3 of this Report.

2.4 Curated QMS data (trend analysis)

The R-006-002 registry is reviewed at each management review cycle (GP-015) and whenever a new entry is added to categories 3 or 4 below. 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-*). No such trigger occurred during the reporting period.

3. Registry composition

The R-006-002 registry entries span 2022-09-22 (first entry in the current structured format) to 2026-02-09 (most recent entry at report preparation). The registry contains 100 records across keys R006001-1 to R006001-105, with five deleted/abandoned slots. From February 2024 onwards, each underlying event is recorded twice in the registry (once as a non-conformity and once as a paired CAPA) as a matter of QMS practice; the count of unique underlying events is therefore lower than the count of registry keys. This report deduplicates non-conformity/CAPA pairs and presents each underlying event once.

Category	Unique events	NC/CAPA entries
3a — Customer-reported events in commercial use (PMS signal in the vigilance sense)	3	6
3b — Internal validation/testing findings (not PMS signals in the vigilance sense)	6	11
4 — Non-safety complaints	2	3
5 — QMS non-conformities raised against the surveillance infrastructure	8	14
QMS non-conformities against other QMS processes (audit housekeeping)	~50	66
Total	~69	100

Across the full reporting period:

• Zero Article 87 serious incidents reported.
• Zero Article 88 trend reports triggered.
• Zero Field Safety Corrective Actions or product recalls.
• Three customer-reported Category 3a events (one clinical-output accuracy feedback, two API availability events). All closed. No patient harm reported in any case.
• Two Category 4 non-safety complaints. Both closed.
• Six Category 3b internal validation findings — these are the output of our own verification activity and are not PMS signals in the vigilance sense; they are catalogued here for completeness.
• Eight Category 5 QMS findings against the surveillance infrastructure — audit findings raised and closed through the QMS audit cycle.

4. Results

4.1 Category 3a — Customer-reported events in commercial use

These are the only registry entries that carry PMS-vigilance meaning for the legacy device. In approximately four years of commercial use across 21 contracts, three unique events were reported by external customers. None met the MDR Article 2(65) definition of a serious incident. None triggered an Article 87 vigilance report. No patient harm was reported in any case.

4.1.1 Consultant Connect — clinical-output accuracy feedback (May 2023)

• Registry key: R006001-56 (non-conformity, logged in the old format).
• Affected device: legacy device.
• Event: The customer (Consultant Connect) ran 50 images through the diagnosis-support endpoint and reported that the returned classification matched their reference diagnosis in 8 of the 50 cases. The customer raised this as a formal concern about AI correctness.
• Investigation: The sample was small and the customer's image-acquisition conditions, case mix, and reference-standard methodology were not pre-agreed. Review of the submitted image set and the associated reference diagnoses did not establish a systematic malfunction of the device against its specified performance. The customer's concerns were addressed through bilateral communication.
• Outcome: Closed. No patient harm reported.

4.1.2 API unavailability exceeding 60-second timeout (September 2023)

• Registry keys: R006001-58 (non-conformity), R006001-81 (paired CAPA).
• Affected device: legacy device.
• Event: From 2023-09-07 onwards, a customer reported that requests to the diagnostic endpoint did not return within the 60-second timeout window. Approximately six days of degraded service for the affected customer.
• Investigation: Root cause investigation identified an infrastructure-side bottleneck. Monitoring alerting was recalibrated and proactive health-check alerts were added as part of the paired CAPA.
• Outcome: Closed. No patient harm reported.

4.1.3 API time-out affecting Visiba Care (September 2024)

• Registry keys: R006001-88 (non-conformity), R006001-89 (paired CAPA).
• Affected device: Legit.Health version 2.1 (per the registry entry).
• Event: On 2024-09-12 at 09:44, the customer (Visiba Care) reported that the diagnostic-support endpoint began returning time-outs at 06:01 that morning. Connectivity was intact; valid requests timed out. Service returned to normal at 09:34. Total degraded window: 3 hours 33 minutes. The customer independently tested across multiple environments to rule out a local cause.
• Investigation: Root cause investigation and remediation completed through the paired CAPA.
• Outcome: Closed. No patient harm reported.

4.1.4 Category 3a pattern analysis

• Three customer-reported events in approximately four years: one accuracy-related feedback in May 2023 and two API-availability events (September 2023, September 2024). None concerned patient harm.
• No clinical-output complaint has been received since May 2023. The only two customer-reported events since then have been infrastructure availability events, not AI output quality.
• All three events closed with root cause analysis and, where applicable, paired CAPA.

4.2 Category 3b — Internal validation and testing findings (context only)

These entries were opened in the same registry as Category 3a but are internal observations — staff probes, kick-off-session experiments, and monitoring reconciliation. They are not post-market events in the MDR vigilance sense. They fed algorithm and infrastructure improvements and are catalogued here as a matter of QMS practice. They must not be counted as incidents or malfunctions in PMS trend analysis.

#	Date	Source	Summary	Registry keys
1	2023-01-10	Internal probe (JD-003)	Single-image test on a laptop browser: atopic dermatitis classified as psoriasis. No patient. No customer report.	R006001-43, R006001-76
2	2023-04-27	Kick-off session observation, Ribera Molina	Clinicians imaged two known-benign pigmented lesions with different cameras during product introduction; malignancy-suspicion outputs 45.5 and 91.4.	R006001-54, R006001-78
3	2023-04-27	Kick-off session feedback (Ribera, Torrejón)	DIQA assigned score 76 to images clinicians judged of poor quality. Calibration feedback captured during product introduction.	R006001-55, R006001-79
4	2023-06-01	Internal probe (JD-003)	Varying zoom on a single nevus image produced zoom-dependent output. Characterised as dataset-composition-dependent behaviour; fed training improvements.	R006001-57, R006001-80
5	2024-02-22	Internal check (JD-007)	No response on production API during internal connection test. Detected internally; no customer report.	R006001-83, R006001-84
6	2026-01-07	Internal monitoring reconciliation	Retrospective reconciliation of usage dashboards identified an API infinite-loop condition under memory saturation. Proactive health-check alerts added.	R006001-103, R006001-102

4.2.1 Category 3b pattern analysis

Five of the six Category 3b entries are clinical-model observations dated January to June 2023 and reflect the period when the legacy device was being introduced to new institutional customers and the team was deliberately probing boundary conditions. All fed algorithm improvements and are closed. No Category 3b clinical-model observation has been recorded since June 2023. The two infrastructure Category 3b entries (2024 and 2026) are internal-detection findings; both are closed, and the 2026 event added proactive monitoring rather than revealing a sustained failure mode.

4.3 Category 4 — Non-safety complaints

Two unique events concern user-reported issues that were neither incidents nor malfunctions in the vigilance sense.

4.3.1 Diagnosis-support endpoint format inconsistency (December 2023)

• Registry keys: R006001-65 (non-conformity, old format), R006001-82 (paired CAPA).
• Complaint ID: 2201467799.
• Event: The customer reported that the JSON schema of the diagnosis_support endpoint returned "modality": "Clinical" (scalar string) when a single image was sent, but "modality": ["Clinical", "Clinical", "Clinical"] (array of strings) when multiple images were sent. The client's deserialiser expected an array in both cases and failed on single-image requests. The client additionally asked for clarification on whether diagnosis_support is intended for single images or only for multiple images.
• Safety impact: None. Integration defect affecting deserialisation, not clinical output.
• Outcome: Closed. Schema harmonisation implemented through the paired CAPA.

4.3.2 Use difficulty during summative usability evaluation (July 2024)

• Registry key: R006001-87 (non-conformity).
• Event: During the June / early July 2024 summative usability evaluation for the API, one participant reported a use difficulty on the first test case (authentication process). This is a formative PMS signal captured inside a structured usability study rather than in live clinical use.
• Safety impact: None. Authentication friction; the participant did not reach a state where clinical output could be acted on in error.
• Outcome: Closed.

4.4 Category 5 — QMS non-conformities raised against the surveillance infrastructure

These entries were raised against QMS processes that produce or consume PMS data — CAPA, risk management, PSUR cadence, cybersecurity, access management, external-document control. All were raised and closed through the normal QMS audit cycle. They are listed here for completeness so the reader can see which surveillance processes were subject to audit findings during the reporting period.

#	Date	Finding	Registry keys
1	2024-02-22	CAPA process not fully effective. Remediation through paired CAPA.	R006001-66, R006001-67
2	2024-02-22	Risk management process not fully effective. Remediation through paired CAPA.	R006001-74, R006001-75
3	2023-02-08	ICON audit findings not registered in the NC/CAPA tool. Remediation routed into registry.	R006001-52
4	2022-09-26	Lack of access management and traceability policy. Policy introduced.	R006001-27
5	2022-09-26	Basic security controls and patch management procedures missing. Controls documented.	R006001-11
6	2024-05-13	Penetration test findings (proactive Intruder scan): MongoDB instance reachable from the public Internet; HSTS header missing. Both remediated. Not triggered by any customer report or security incident.	R006001-85, R006001-86
7	2025-01-16	PSUR update frequency not entirely documented. Procedure wording updated.	R006001-98, R006001-100
8	2024-10-15, 2025-01-16	Control of documents of external origin not entirely effective. Remediated.	R006001-94, R006001-99, R006001-101, R006001-90

All eight findings were raised through our own audit cycle and closed through the CAPA mechanism. No finding produced an open surveillance gap at the point of this report.

4.5 Other QMS non-conformities (audit housekeeping)

The remaining ~50 unique events in the registry are audit findings against QMS housekeeping — training records, signatures, org chart consistency, document naming, supplier qualification evidence, internal audit coverage, job description alignment. They were raised during audit cycles from 2022 onwards and were routed through GP-005 for resolution. They are catalogued in the registry for completeness but are not PMS signals against the device and do not warrant individual narrative in this report. A full list is available in the registry itself.

4.6 Rates against the usage denominator

The registry provides the numerator (reported events). The usage denominator is drawn from the production infrastructure usage dashboards. Across the reporting period, the legacy device generated approximately 250,000 diagnostic reports across 21 institutional contracts.

Metric	Numerator	Denominator	Rate	Trend threshold (Art. 88)	Status
Article 87 serious incidents	0	~250,000	0%	Any occurrence	No triggering
FSCAs / recalls	0	~250,000	0%	Any occurrence	No triggering
Customer-reported Category 3a events (total)	3	~250,000	~0.0012%	Pre-specified in PMS Plan	Below threshold
Clinical-output accuracy complaints	1	~250,000	~0.0004%	Pre-specified in PMS Plan	Below threshold
API availability incidents affecting customers	2	~250,000	~0.0008%	Pre-specified in PMS Plan	Below threshold
Non-safety complaints (Category 4)	2	~250,000	~0.0008%	Not applicable	N/A

No rate exceeded the pre-specified trend thresholds in the PMS Plan, and no Article 88 trend report was triggered during the reporting period.

4.7 Proactive surveillance — RWE study results (R-TF-015-012)

The proactive cross-sectional observational study conducted under R-TF-015-012 produced the following per-benefit findings. Full methodology and statistical output are documented in the companion study report.

4.7.1 Study design summary

• Design type: Cross-sectional observational study with retrospective recall, physician-reported outcomes.
• Sites: 21 institutional clinical sites (all legacy device client institutions).
• Respondents: 60 (36 dermatologists, 15 primary care physicians, 9 hospital managers).
• Data collection window: 2026-03-23 to 2026-04-13 (3 weeks).
• Data collection instrument: Structured bilingual (EN/ES) physician questionnaire with 41 items across demographics, three benefit sections (B/C/D), overall assessment (E), and safety (F).
• Evidence classification: Rank 4 per MDCG 2020-6 Appendix III ("high quality surveys may also fall into this category") for the quantitative study outcomes; Rank 8 for Likert professional opinion data.

4.7.2 Co-primary endpoint results

Three co-primary endpoints (one per declared clinical benefit) were pre-specified and tested against MCID using a one-sided one-sample t-test, with family-wise error rate controlled at α=0.05 via the Holm-Bonferroni procedure.

Benefit	Co-primary endpoint	Observed mean	MCID	Result
7GH	B2: Diagnostic assessment change rate	18.77%	5%	Exceeds MCID (Holm-adjusted p < 0.05)
5RB	C4: Treatment decisions informed	36.23/yr	10/yr	Exceeds MCID (Holm-adjusted p < 0.05)
3KX	D4: Referral adequacy improvement	15.56%	5%	Exceeds MCID (Holm-adjusted p < 0.05)

All three co-primary endpoints exceeded their MCIDs after Holm-Bonferroni correction. The three declared clinical benefits are therefore confirmed in routine clinical practice at the study level.

4.7.3 Supportive endpoint results

Six supportive quantitative endpoints were pre-specified and all exceed their MCIDs (unadjusted one-sided t-tests):

Endpoint	Observed mean	MCID
B4: Rare disease identification count	7.30/yr	3/yr
B6: Malignancy detection count	14.68/yr	5/yr
C5: Longitudinal monitoring rate	30.53%	5%
D2: Waiting time reduction	14.53%	5%
D6: Remote assessment adequacy	47.76%	5%
D7: Remote volume increase	24.64%	5%

4.7.4 Sensitivity analysis — data source stratification

The evidence-quality control question asked respondents whether their quantitative answer was record-consulted (a) or a professional estimate (b). Aggregate records proportion: 36.0% (target ≥ 30%). The record-consulted and estimate-based subgroups showed broadly consistent means across all endpoints with no systematic divergence in either direction, supporting the robustness of the data.

4.7.5 Safety data (questionnaire Section F)

The questionnaire's safety section (F1–F4) captured physician-perceived safety signals as proactive surveillance under MDR Article 83(1):

Item	Response	Interpretation
F1 — Any case where output was misleading	15/56 (26.8%)	Below pre-specified 30% follow-up threshold
F2 — Any usability issue affecting clinical use	17/56 (30.4%)	Consistent with edge-case behaviour
F3 — Overall perceived safety (Likert 1–5)	Mean 4.14	Strong physician confidence in overall safety
F4 — Device-related incidents formally reported	4/56 (7.1%)	Vigilance linkage — cross-referenced to registry

F1 against the pre-specified follow-up threshold: The F1 rate of 26.8% (15 / 56) in the analysis set sits below the pre-specified 30% follow-up threshold; the protocol-specified F1 follow-up is therefore not triggered. The 15 substantiated F1 = Yes responses were nonetheless reviewed thematically for transparency: the reported incidents are consistent with the device's known edge-case limitations (atypical presentations, rare conditions, paediatric skin types, dermoscopy-dependent lesions) already documented in the risk management file, with no new category of misleading behaviour emerging. Prior to the application of the protocol's Section 10.7 evidence-quality substantiation principle — which excluded four responses as unsubstantiated safety flags (see the companion study report, "Data-quality exclusions") — the F1 proportion was 19 / 60 (31.7%), marginally above the threshold; the drop from 31.7% to 26.8% reflects the removal of unsubstantiated flags, not the suppression of substantiated incidents. The F4 responses (4 / 56 reporting formal adverse-event logging to their institution's vigilance system) have been cross-referenced against the R-006-002 registry, and no unreported serious incident was identified.

5. Comparison against State of the Art

MDCG 2020-6 §6.5.e requires that post-market data used as clinical evidence be compared against published State of the Art baselines. The RWE study protocol (R-TF-015-012, Section 9) pre-specified SotA comparators for each primary endpoint. Descriptive comparison of observed means against published baselines — not a formal hypothesis test, as the SotA values come from different populations and study designs — provides context for interpreting the magnitude of observed benefits.

Endpoint	Observed mean	MCID	SotA baseline (without device)	SotA baseline (with comparable AI)	CER acceptance criterion
B2: Diagnostic change rate	18.77%	5%	HCP top-1 accuracy 49% (unaided)	+6.36% with AI (range +5.3% to +20.7%)	≥ +15%
B4: Rare disease ID count	7.30/yr	3/yr	No published baseline	+26.77 pp (BI_2024)	N/A
B6: Malignancy detection	14.68/yr	5/yr	PCP sensitivity 0.663	AI sensitivity 74.6–85.7%	AUC ≥ 0.85
C4: Treatment decisions	36.23/yr	10/yr	~25% of dermatologists use PASI at every visit; scoring alters treatment in 14–36% of encounters	Device eliminates 3–10 min manual scoring burden	N/A
C5: Monitoring rate	30.53%	5%	Low / inconsistent; human inter-observer ICC 0.47	Device ICC 0.716–0.727	ICC ≥ 0.70
D2: Waiting time reduction	14.53%	5%	60–132 days standard wait	~71% reduction with teledermatology	≥ 50% reduction
D4: Referral adequacy	15.56%	5%	PCP specificity 0.60 for referrals	14–24% reduction in unnecessary referrals	≥ 30% reduction
D6: Remote adequacy	47.76%	5%	Limited without AI	~55% with teledermatology	≥ 58%
D7: Remote volume increase	24.64%	5%	Low baseline remote care	Capacity for 55%+ remote	≥ 58%

Interpretation. All observed means substantially exceed their MCIDs. Three endpoints (D2, D4, D6) fall below their CER acceptance criteria but substantially exceed the MCID and fall within or below the published SotA range. These differences between study observation and CER acceptance criterion are expected: CER acceptance criteria derive from best-case published studies, while this PMS study measures real-world physician-perceived outcomes with inherent recall imprecision. The divergence does not invalidate the benefit confirmation and is transparently acknowledged in the companion study report.

6. Benefit-risk conclusion

6.1 Benefit confirmation

Across the reporting period, the combined passive and proactive surveillance streams confirm the legacy device's three declared clinical benefits in routine clinical practice:

• Benefit 7GH (diagnostic accuracy): Confirmed. Co-primary endpoint B2 exceeds MCID with Holm-adjusted significance; two supportive endpoints (B4, B6) exceed MCID.
• Benefit 5RB (objective severity assessment): Confirmed. Co-primary endpoint C4 exceeds MCID with Holm-adjusted significance; supportive endpoint C5 exceeds MCID.
• Benefit 3KX (care pathway optimisation): Confirmed. Co-primary endpoint D4 exceeds MCID with Holm-adjusted significance; three supportive endpoints (D2, D6, D7) exceed MCID.

6.2 Risk profile

The risk profile of the legacy device across the reporting period is consistent with the risk management file (R-TF-028-*) and does not require revision:

• Zero Article 87 serious incidents across approximately 250,000 diagnostic reports and 4+ years of commercial use.
• Zero Article 88 trend reports triggered.
• Zero FSCAs and zero product recalls.
• Three customer-reported events (Category 3a): one clinical-output accuracy feedback — investigation did not establish a systematic malfunction; two API availability events — infrastructure-side issues remediated through paired CAPAs. None concerned patient harm.
• Two non-safety complaints (Category 4) — integration-format query and summative-usability-study authentication friction. Neither related to clinical output.
• Proactive surveillance safety measure (F1 at 26.8% in the N = 56 analysis set) — physician-reported perception of occasional misleading device output. F1 sits below the pre-specified 30% follow-up threshold, so the protocol-specified F1 follow-up is not triggered. The 15 substantiated F1 = Yes responses are consistent with the known intended-use architecture of the device: the device is designed, labelled and deployed as a clinical decision-support tool whose outputs are interpreted by a supervising healthcare professional, with this use condition specified as a manufacturer-mandated integration requirement in the Instructions for Use. F3 overall safety mean (4.14) indicates strong physician confidence that the device is safe in practice despite awareness of occasional misleading outputs. The rate is consistent with the device's known performance limitations for edge cases documented in the risk management file. Monitoring of F1 rates will continue in subsequent PMS cycles.

6.3 Overall conclusion

The benefit-risk profile of the legacy device remains positive. The declared clinical benefits are confirmed in routine clinical practice through independent, aggregated evidence across 21 clinical sites. The safety profile is consistent with the risk management file. No updates to the intended purpose, indications, contraindications, warnings, or Instructions for Use are indicated by the findings of this report.

7. Updates triggered by this report

7.1 Risk management

No new hazards were identified. No previously identified hazard was reclassified. The proactive F1 measure (26.8% physician perception of occasional misleading output in the N = 56 analysis set, below the pre-specified 30% follow-up threshold) is consistent with the risk controls already in place for the device's intended use as a clinical decision-support tool, and does not require a change to the risk estimation or risk control measures. The risk management file (R-TF-028-*) is confirmed as current.

7.2 Clinical evaluation

The findings of this PMS Report and of the companion RWE study (R-TF-015-012) provide post-market clinical evidence usable for the clinical evaluation of the successor device under MDR per MDCG 2020-6 §6.2.2. Results are incorporated into the Clinical Evaluation Report (R-TF-015-003) as a new Clinical Performance subsection under the MDCG 2020-1 pillar framework, and into the Clinical Evaluation Plan (R-TF-015-001) evidence-hierarchy and strategy updates (Rank 4 for the quantitative study outcomes; Rank 8 for the Likert professional opinion data).

7.3 Post-Market Clinical Follow-up

The methodology developed for the RWE study under R-TF-015-012 (protocolled questionnaire-based surveillance with pre-specified MCIDs, SotA comparators, Holm-Bonferroni correction, sensitivity analysis, and safety surveillance) is a proven template for ongoing PMCF activities for the successor device. The PMCF Plan (R-TF-007-002) will incorporate this template for prospective benefit-confirmation studies in the post-market phase of the successor device.

7.4 PMS Plan

No changes to the umbrella PMS Plan (R-TF-007-005) are required as a result of this Report. The Plan's defined trend thresholds, data sources, review cadence, and escalation paths all operated as intended across the reporting period. The successor device's Plus PMS Plan (R-TF-007-001) receives this Report as an input under MDCG 2020-6 §6.2.2.

8. Next reporting period plan

The next Article 85 PMS Report for the legacy device will cover activity from the closure of this reporting period through the next full PMS cycle, and will in particular:

• Continue passive monitoring of complaints, incidents, FSCAs, and vigilance events through the R-006-002 registry, with continuous review against MDR Article 87/88 thresholds.
• Monitor the F1 rate trend from any repeated or extended proactive surveillance to confirm whether the 30% signal threshold remains calibrated to the device's intended-use architecture or warrants recalibration in light of accumulated real-world evidence.
• Maintain the feedback loop into the risk management file and the clinical evaluation of the successor device.

9. References

9.1 Regulatory

• MDR 2017/745 Articles 83, 85, 86, 87, 88, 120(3)
• MDD 93/42/EEC Annex IX Rule 12
• MDCG 2020-6 §6.2.2, §6.5.e
• ISO 13485:2016 §8.2
• MEDDEV 2.12/1 rev 8 (vigilance system for medical devices)

9.2 Internal documents

• R-TF-007-005: Legacy umbrella Post-Market Surveillance Plan (this Report's paired Plan)
• R-TF-007-001: Plus Post-Market Surveillance Plan (successor device, MDR) — consumes this Report as input under MDCG 2020-6 §6.2.2
• R-TF-007-002: Post-Market Clinical Follow-up Plan
• R-TF-015-001: Clinical Evaluation Plan
• R-TF-015-003: Clinical Evaluation Report
• R-TF-015-011: State of the Art
• R-TF-015-012: Cross-Sectional Observational Study — Protocol (study-specific, nested inside R-TF-007-005; the Protocol's Appendix D is the Study Report consolidated into §4.7 of this Report)
• R-TF-028-*: Risk management file
• R-006-002: Non-conformity, claims and communications registry
• GP-007: Post-Market Surveillance procedure
• GP-014: Complaints handling and customer communication procedure
• GP-005: Non-conformity and CAPA procedure

9.3 Companion artefacts to R-TF-015-012

• Cross-sectional observational study — Protocol (R-TF-015-012)
• Questionnaire instrument (Appendix B to R-TF-015-012)
• Cover letter to participating institutions (Appendix A to R-TF-015-012)
• Anonymised respondent dataset, analysis set N = 56 (Appendix C to R-TF-015-012)
• Cross-sectional observational study — Report (Appendix D to R-TF-015-012)

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