R-TF-007-001 Post-Market Surveillance (PMS) Plan

Purpose

This plan describes product-specific post-market surveillance activities to monitor the safety and performance of devices placed on the market and continuously review the benefit-risk analysis.

Scope

This PMS plan applies to:

• Legit.Health Plus (version 1.1.0.0): this is our class IIb medical device according to the requirements set out in MDR 2017/745.

This plan is for the device Legit.Health Plus, but to define the post-market activities for the Legit.Health Plus, we will need summarise the results of the activities of the PMS report of Legit.Health device (class I legacy device). Then, next year, the PSUR for Legit.Health Plus device (class IIb) will be updated. Legit.Health (version 2.1) is our class I legacy device certified according to the requirements set out in MDD 93/42/EEC. The period under evaluation for the class I legacy device is from January 2021 to December 2025.

Device lifetime

In accordance with UK Medical Devices Regulations 2002 (as amended) and MHRA guidance on post-market surveillance, the expected lifetime of Legit.Health Plus is 10 years from the date of first placing on the market. This lifetime estimate is based on:

• The software nature of the device (no physical degradation)
• Continuous updates and maintenance as part of the software lifecycle
• Ongoing cybersecurity support and vulnerability management
• Expected technological relevance and clinical utility

The PMS activities described in this plan will continue throughout the device lifetime to ensure ongoing safety and performance monitoring.

Surveillance period

The period under evaluation for the class IIb device (Legit.Health Plus) will cover from the date of the first device placed on the market up to one calendar year.

Regulatory references

This Post-Market Surveillance Plan follows the requirements set out in:

• Regulation (EU) 2017/745 on medical devices, specifically Articles 83, 84, 86 (as applicable), and Annex III in its entirety
• UK Medical Devices Regulations 2002 (SI 2002/618, as amended), Part IV - Post-market surveillance requirements for devices placed on the UK market
• MHRA Guidance on vigilance - medical device incident reporting and investigation requirements for the UK market

For devices placed on both EU and UK markets, this PMS plan addresses the requirements of both regulatory frameworks.

Abbreviations

• PMS: Post-market surveillance
• PMCF: Post-market clinical follow up
• FSCA: Field Safety Corrective actions
• CAPA: Corrective Action Preventive Action
• PSUR: Periodic Safety Update Report
• CER: Clinical Evaluation Report
• PMCF report: Post-Market Clinical Follow-up report

General considerations

Annex III sections 1.1(a) and 1.1(b) of MDR 2017/745 describe the requirements applicable to the post-market surveillance plan. Point (a) specifies the sources of information that the plan shall address, and point (b) specifies the minimum content of the plan.

The table below shows the regulatory requirements and how we comply with them:

MDR requirement	Activity
Annex III 1(a) — The post-market surveillance plan shall address the collection and utilization of available information, in particular: information concerning serious incidents, including information from PSURs, and field safety corrective actions; records referring to non-serious incidents and data on any undesirable side-effects; information from trend reporting; relevant specialist or technical literature, databases and registers; information, including feedback and complaints, provided by users, distributors and importers; and publicly available information about similar medical devices	R-TF-007-001 Post-Market Surveillance (PMS) Plan, § Data collection activities (consolidated mapping of all six information sources); GP-004 Vigilance system, § Receipt of notification of an incident; § Field Safety Corrective Action (FSCA); § Trend report; GP-014 Feedback and complaints, § Information coming from customers; § Customer complaint management; GP-007 Post-market surveillance, § Active monitoring of the information received (specialist literature, similar devices, state of the art)
A proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market	GP-007 Post-market surveillance, § Post-market surveillance system; § Active monitoring of the information received
Effective and appropriate methods and processes to assess the collected data	GP-020 Data analysis, § Data analysis procedure
Suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I	R-TF-007-001 Post-Market Surveillance (PMS) Plan, § Indicators and threshold values for benefit-risk reassessment; § Trend analysis; R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan, § Specific PMCF Methods
Effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field	GP-014 Feedback and complaints, § Information coming from customers; § Customer complaint management; § Customer complaint investigation and evaluation
Methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period	GP-004 Vigilance system, § Trend report; GP-020 Data analysis, § Data analysis procedure; R-TF-007-001 Post-Market Surveillance (PMS) Plan, § Trend analysis
Methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users	GP-004 Vigilance system, § Notification to Regulatory Authorities; § Field Safety Corrective Action (FSCA); § Criteria to notify an incident to the national competent authorities
Reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86	GP-007 Post-market surveillance, § Post-market surveillance (PMS) plan; § Periodic Safety Update Report (PSUR)
Systematic procedures to identify and initiate appropriate measures including 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
Effective tools to trace and identify devices for which corrective actions might be necessary	GP-016 Traceability and identification, § Traceability; § Product serial number and UDI assignment; SP-004-001 Product withdrawal, § Procedure
A PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable	R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan

Data collection activities

The following table provides a summary of the identified PMS activities together with responsibilities, frequency of the activities and documents where the activities and their results are detailed.

PMS Activity	Responsible Person	Frequency of Review	Initial Data Source Procedure (IDSP)	MDR Vigilance Type	Data Collected / Focus	Data Type (Quant/Qual)
Legacy Device Data	JD-004 / JD-005	Annual / As Needed	GP-007 (PMS), Historical Technical Files (MDD)	Proactive / Reactive	Historical incident reports, clinical data, performance issues from previous regulations.	Quantitative/Qualitative
Serious incidents and FSCA documentation	JD-004	Annual	GP-004 (Vigilance system), GP-006 (CAPA)	Reactive	Severe adverse events, trends, root cause analysis, risk reduction measures.	Quantitative/Qualitative
Non-serious incidents and undesirable side-effects documentation	JD-004 / JD-005	Annual	GP-004 (Vigilance system)	Reactive	Minor adverse events, high-volume/low-severity trends, early warning signals.	Quantitative
Customer feedback documentation	JD-005 / JD-016	Annual	GP-014 (Feedback and complaints)	Proactive/Reactive	User satisfaction, usability issues, suggestions for improvement, minor non-conformities.	Qualitative
Customer complaints documentation	JD-004	Annual	GP-014 (Feedback and complaints)	Reactive	Product failures, discrepancies in performance, reported harms, complaint resolution status.	Quantitative/Qualitative
Corrective and preventive actions (CAPA)	JD-004	Annual	GP-006 (Non-conformities, CAPA)	Reactive	Effectiveness check of actions taken, systemic issues.	Qualitative
Research data about similar devices in the market	JD-005	Annual	GP-007 (PMS)	Proactive	Safety and performance data of competing/equivalent devices, identification of new risks.	Quantitative/Qualitative
Research updates of standards and legislation	JD-004	Annual	GP-007 (PMS)	Proactive	Changes in harmonised standards, MDR updates, national implementing laws.	Qualitative
Analyse trends, decide on necessary measures and implement them	JD-005	Annual	R-TF-007-001 (PMS Plan, § Trend analysis), GP-006 (CAPA)	Proactive/Reactive	Statistical analysis of incident/complaint data, early detection of statistically significant increases.	Quantitative
Clinical literature review	JD-005	Annual	GP-007 (PMS) / R-TF-007-002 (PMCF Plan)	Proactive	New clinical data, long-term safety/performance, state-of-the-art for the device category.	Qualitative
Research on cybersecurity and state of the art	JD-005	Annual	GP-007 (PMS)	Proactive	Identified security flaws, patch status, industry best practices, new technologies.	Qualitative
Research on security vulnerabilities of SOUPs and software tools	JD-017	Semi-annual	GP-007 (PMS)	Proactive	Known vulnerabilities in third-party software (Software of Unknown Provenance), dependency scanning.	Qualitative
Conduct post-market clinical follow-up (PMCF) activities	JD-005	Annual	R-TF-007-002 (PMCF Plan)	Proactive	Targeted clinical data collection, long-term safety, device performance in the target population.	Quantitative/Qualitative
Update risk management file	JD-004	Annual	GP-006 (CAPA) / GP-007 (PMS)	Proactive/Reactive	New/changed risks, risk-benefit ratio re-evaluation, residual risk acceptability.	Qualitative

Legacy Device Data

Legacy device data is collected and reviewed by JD-004 and JD-005 on an annual or as-needed basis. The data sources are the legacy-device umbrella PMS Plan R-TF-007-005, the paired umbrella PMS Report R-TF-007-003 (MDR Article 85 via MDR Article 120(3) for the legacy Class I MDD device) and the study-specific cross-sectional observational study Protocol R-TF-015-012 and its Report (Appendix D to R-TF-015-012). Together these documents capture four-plus years of continuous commercial deployment across 21 active client contracts and approximately 250,000 diagnostic reports. This proactive and reactive activity focuses on the historical incident pattern, clinical-performance outcomes, residual uncertainties and safety signals carried forward from the legacy programme, and is both quantitative and qualitative. The legacy-device post-market evidence is a named input to the Plus PMS system under MDCG 2020-6 §6.2.2; the five specific integration points (benefit-confirmation continuity; carried-forward safety signals; surveillance-cadence rationale; residual uncertainties routed to PMCF; evidence-quality substantiation continuity) are implemented in the subsections below and in R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan.

Surveillance cadence — calibrated against legacy-device operational experience

The annual PSUR cycle and quarterly quality-indicator reviews declared in § Surveillance period and § Trend analysis are calibrated against the legacy-device operational experience documented in R-TF-007-003, not defaulted from a template. Over the legacy reporting period the device generated approximately 250,000 diagnostic reports across 21 active client contracts with zero MDR Article 87 serious incidents (rule-of-three one-sided 95% upper bound ≤ 3 / 250,000 ≈ 0.0012%), zero Article 88 trend reports triggered, zero Field Safety Corrective Actions, and seven non-serious complaints closed through the R-006-002 non-conformity registry. This operational pattern justifies the annual PSUR cadence with quarterly interim quality-indicator reviews for the Plus device as proportionate under MDR Article 83; any deviation from this pattern during Plus post-market deployment (detected via the trend-analysis threshold in § Trend analysis or via the carried-forward safety-signal baselines in § Carried-forward safety-signal baselines from legacy post-market) triggers escalation to an unscheduled benefit-risk reassessment. The rule-of-three upper bound stated above is descriptive context for the legacy denominator; the Plus-side reassessment trigger is the MDR baseline — any single confirmed MDR Article 87 serious incident, any confirmed Article 88 trend report, or any FSCA during Plus deployment triggers PSUR entry and benefit-risk reassessment regardless of current Plus denominator.

Serious incidents and FSCA

Serious incidents are documented, notified to Regulatory Authorities, investigated and addressed according to the requirements set out in GP-004 Vigilance system and in GP-006 Non-conformities, Corrective and preventive actions. Once a year, JD-004 will actively analyse the new data collected from the vigilance system. The PSUR will summarize the number of reported serious incidents, their investigation results and any taken subsequent measures. The same approach is followed for Field Safety Corrective Actions (FSCA): they are documented, notified to Regulatory Authorities and implemented according to the requirements set out in GP-004 Vigilance system and in SP-004-001 Product withdrawal. The PSUR will summarize the number of FSCA initiated and their status (ongoing, completed).

Non-serious incidents and undesirable side-effects

Non-serious incidents and undesirable side-effects are documented, investigated and addressed according to the requirements set out in GP-004 Vigilance system. The non-conformities detected are registered in the T-006-001 Non-conformity report and are reviewed every 3 months to monitor their status. They are also reviewed on a yearly basis by JD-004 and the evaluation results and conclusions will be summarised in the PSUR. Minor adverse events, high-volume/low-severity trends, and early warning signals are monitored as part of this process.

Customer feedback

Feedback from users is documented, analysed and addressed according to the requirements set out in GP-014 Feedback and complaints and is evaluated every year by JD-005 and JD-016 to identify any actions and improvements to be implemented on the products. This includes user satisfaction, usability issues, suggestions for improvement, and minor non-conformities. Evaluation and results of user feedback will be summarised in the PSUR.

Customer complaints

Customer complaints are documented, analysed and addressed as explained in GP-014 Feedback and complaints. As part of the analysis, JD-005 or JD-004 will identify whether there are any non-serious incidents or serious incidents and categorise them as such. In case of serious incidents, we will follow the reporting process described in GP-004 Vigilance system. Customer complaints will be reviewed on a yearly basis by JD-004 and the results of the revision will be summarised in the PSUR.

Corrective and preventive actions (CAPA)

Corrective and preventive actions are documented, investigated, implemented and verified for effectiveness according to the requirements set out in GP-006 Non-conformities, CAPA. These actions are reviewed every 3 months by JD-004 to review their status and/or their effectiveness. Once a year, JD-004 performs an additional review and the evaluation results and conclusions will be summarised in the PSUR. The focus is on the effectiveness check of actions taken and identification of systemic issues.

Research data about similar devices in the market

Research data about similar devices is gathered and reviewed annually by JD-005 using GP-007 (PMS) as the data source. This proactive activity focuses on safety and performance data of competing or equivalent devices and identification of new risks. The results are both quantitative and qualitative and are used to inform the ongoing PMS activities.

Research updates of standards and legislation

Research updates of standards and legislation are performed annually by JD-004 using GP-007 (PMS) as the data source. This proactive activity focuses on changes in harmonised standards, MDR updates, and national implementing laws. The results are qualitative and are used to ensure ongoing compliance.

Trend analysis

Trend analysis is performed annually by JD-005 using the data collected from all PMS activities described in this plan, together with GP-006 (CAPA) records. This activity is both proactive and reactive and focuses on statistical analysis of incident and complaint data and early detection of statistically significant increases.

Observation period

The primary observation period for trend analysis is annual, aligned with the PSUR cycle. Quality indicators (T-002-003 Quality indicators) are reviewed quarterly to enable early detection of emerging trends within each annual period. Multi-year comparisons are performed at each annual management review to identify long-term patterns, as described in GP-020 Data analysis, § Data analysis procedure.

Statistical methods and threshold for statistically significant increase

Trend analysis uses statistical and comparison techniques as described in GP-020 Data analysis, § Data analysis procedure. Current-period data is compared with historical data from previous observation periods. As defined in GP-020, each new trend that exceeds the historic or foreseeable information by 25% is registered as a T-006-001 Non-conformity report (when required) or a T-020-001 Trend report, containing: the finding and its historic information, comparison with historic and/or foreseeable data, investigation of the causes, defined actions, follow-up actions, and responsibilities.

A 25% increase over historic or foreseeable data constitutes the threshold for a statistically significant increase in the frequency or severity of incidents, as required by Article 88 of MDR 2017/745.

Escalation and reporting

If a statistically significant increase in the frequency or severity of incidents is identified, the following actions are taken:

• A T-006-001 Non-conformity report is opened, and the CAPA process described in GP-006 Non-conformities, Corrective and preventive actions is initiated.
• If the trend involves incidents that are generally excluded from the obligation to be individually notified, a trend report is submitted to the NCA using the MEDDEV 2.12-1 rev.8 Annex VII: Manufacturer's trend report form, as described in GP-004 Vigilance system, § Trend report.
• The trend analysis results and any measures taken are documented in the PSUR.

Clinical literature review

Clinical literature is reviewed annually by JD-005 using GP-007 (PMS) and R-TF-007-002 (PMCF Plan) as data sources. This proactive activity focuses on new clinical data, long-term safety and performance, and the state-of-the-art for the device category. The results are qualitative and are summarised in the PMCF evaluation report.

Research on cybersecurity and state of the art

Research on cybersecurity and state of the art is performed annually by JD-005 using GP-007 (PMS) as the data source. This proactive activity focuses on identified security flaws, patch status, industry best practices, and new technologies. The results are qualitative and are used to maintain cybersecurity effectiveness.

Research on security vulnerabilities of SOUPs and software tools

Research on security vulnerabilities of SOUPs and software tools is performed semi-annually by JD-017 using GP-007 (PMS) as the data source. This proactive activity focuses on known vulnerabilities in third-party software (Software of Unknown Provenance) and dependency scanning. The results are qualitative and are used to mitigate risks related to software components.

Conduct post-market clinical follow-up (PMCF) activities

Post-market clinical follow-up activities are conducted annually by JD-005 using R-TF-007-002 (PMCF Plan) as the data source. This proactive activity focuses on targeted clinical data collection, long-term safety, and device performance in the target population. The results are both quantitative and qualitative and are summarised in the PMCF evaluation report.

Update risk management file

The risk management file is updated annually by JD-004 using GP-006 (CAPA) and GP-007 (PMS) as data sources. This proactive and reactive activity focuses on new or changed risks, risk-benefit ratio re-evaluation, and residual risk acceptability. The results are qualitative and are used to ensure ongoing risk management.

Integration of PMS and PMCF results into risk management and clinical evaluation:

• All relevant findings from PMS and PMCF activities (including new risks, changes in frequency/severity, and emerging safety signals) are systematically reviewed and incorporated into the risk management file.
• The risk management process is closely linked to the clinical evaluation, ensuring that any new information affecting the benefit-risk profile is reflected in the Clinical Evaluation Report (CER).
• Identified risks or changes are assessed for impact, and risk control measures are updated as necessary.
• This integration ensures continuous alignment with MDR requirements and supports the ongoing demonstration of device safety and performance.

Indicators and threshold values for benefit-risk reassessment

The following specific indicators and threshold values are used in the continuous reassessment of the benefit-risk analysis and risk management, as required by Annex III 1(b) of MDR 2017/745.

Trend detection threshold

As defined in GP-020 Data analysis, § Data analysis procedure, any new trend that exceeds the historic or foreseeable information by 25% triggers a formal investigation. The trend is registered as a T-020-001 Trend report or, when applicable, a T-006-001 Non-conformity report with root cause analysis and corrective actions per GP-006 Non-conformities, Corrective and preventive actions.

Clinical performance thresholds (PMCF)

The following clinical performance thresholds are defined in R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan, § Specific PMCF Methods, Activity C.1: Image-based diagnosis non-interventional performance analysis (Code: PMCF-ICD-DXP-2026), under Acceptance Criteria, and are monitored as part of the ongoing benefit-risk reassessment:

• AUC > 0.8
• Top-5 >= 70%
• Top-3 >= 55%
• Top-1 >= 40%

Sustained performance below any of these thresholds triggers a reassessment of the benefit-risk determination.

Severity assessment agreement (PMCF)

For automated severity assessment, agreement with clinical gold standards is measured using the Interobserver Correlation Coefficient (ICC), as defined in R-TF-007-002 PMCF Plan, § Specific PMCF Methods, Activities B.1–B.5.

Quality indicators

Quality objectives and indicators are established in T-002-002 Quality objectives and T-002-003 Quality indicators. These are reviewed quarterly and compared against expected values at each annual management review, as described in GP-020 Data analysis, § Data analysis procedure and GP-002 Quality planning.

Carried-forward safety-signal baselines from legacy post-market

The legacy-device post-market programme established pre-specified, denominator-bearing values for four safety items through the cross-sectional observational study (R-TF-015-012, analysis set N = 56 after the pre-specified Section 10.7 evidence-quality substantiation principle). Items F1, F2 and F4 are proportion-valued (percentage of respondents answering "Yes" with substantiation); F3 is a Likert mean across respondents. All four are Rank-8 professional-opinion signals per MDCG 2020-6 Appendix III, not Rank-4 clinical-outcome rates, and are used as sensitive early-warning triggers alongside the Article 88 statistical-increase threshold.

Item	Legacy baseline value (N = 56)	Plus measurement unit and sampling frame	Plus breach trigger (subject to minimum-N rule below)
F1 — Physician observation of potentially-misleading device output	26.8 % (below 30 % threshold)	Proportion of Plus-site physicians in the annual PSUR survey reporting a substantiated F1 = Yes	Observed Plus proportion exceeding 30 % with one-sided exact 95 % lower CI above 30 %, triggering unscheduled CER / benefit-risk reassessment
F2 — Usability issues affecting clinical use	30.4 %	Proportion of Plus-site physicians in the annual PSUR survey reporting a substantiated F2 = Yes	Observed Plus proportion exceeding 40 % with one-sided exact 95 % lower CI above 40 %, triggering root-cause analysis and CAPA under GP-006
F3 — Overall perceived safety (Likert 1–5)	Mean 4.14 / 5	Annual-window mean Likert response across all Plus-site physicians who completed the F3 item	Observed annual-window mean below 3.5 with one-sided 95 % upper confidence bound below 3.5, triggering thematic review against risk-management file
F4 — Formal institutional incident or adverse-event report	7.1 %	Proportion of Plus-site physicians reporting a substantiated F4 = Yes in the annual PSUR survey	Observed Plus proportion exceeding 10 % with one-sided exact 95 % lower CI above 10 %, triggering cross-check against the complaints registry and CAPA
Aggregate passive-surveillance pattern (vigilance, trend, FSCA history)	0 Art. 87; 0 Art. 88; 0 FSCA	MDR-mandated individual-event reporting (not proportion-based); denominator-independent	Any single confirmed Article 87 serious incident, confirmed Article 88 trend report, or FSCA during Plus deployment triggers PSUR entry

Minimum-N rule. Proportion-based triggers for F1, F2 and F4, and the Likert-mean trigger for F3, are only evaluated when the annual PSUR survey has at least N = 30 substantiated responses per item. This minimum-N requirement mirrors the Obuchowski-Rockette / Hillis reader-count framework used in PMCF Activity C.1 and avoids false-firing on small annual samples while preserving the pre-specified early-warning intent.

Sources: R-TF-007-003 § 4.7 (umbrella consolidation of the Section F safety signals) and R-TF-015-012 Appendix D § Safety. These baselines are applied alongside the trend-detection threshold above; they do not replace the Article 88 statistical-increase threshold but provide a more sensitive pre-specified reference that shortens time-to-detection for the specific safety items observed in the legacy evidence. Deviations from any baseline are recorded through the T-020-001 Trend report or T-006-001 Non-conformity report as appropriate and are summarised in the annual PSUR.

Benefit-risk reassessment triggers

A reassessment of the benefit-risk determination is initiated when any of the following occurs:

• A trend exceeding the 25% threshold is confirmed
• Clinical performance falls below any of the PMCF thresholds listed above
• Any carried-forward safety-signal baseline listed in § Carried-forward safety-signal baselines from legacy post-market is breached during Plus post-market deployment
• A new risk is identified through PMS or PMCF activities that was not previously included in the risk management file
• A statistically significant increase in the frequency or severity of incidents is detected
• New clinical evidence from literature review or PMCF activities contradicts the existing benefit-risk determination

The reassessment follows the procedures described in GP-013 Risk management and GP-015 Clinical evaluation, and the results are documented in the PSUR and the updated T-015-003 Clinical Evaluation Report.

PMCF activities

A PMCF plan has been developed for the device to consistently collect relevant clinical data, confirming the benefit-risk determination in the Risk Management Report (R-TF-013-003) and Clinical Evaluation Report (R-TF-015-003).

In accordance with Annex XIV Part B of MDR 2017/745 and MDCG 2020-7 guidance, the need for PMCF for this class IIb device is justified as follows:

• The device is innovative medical software with new functionalities and algorithms.
• There are residual clinical uncertainties after the initial clinical evaluation.
• It is necessary to confirm long-term safety and performance in the target population and under real-world conditions.

The PMCF plan includes:

• Systematic collection of post-market clinical data.
• Ongoing monitoring of safety and performance in clinical practice.
• Identification of emerging risks and verification of the acceptability of the benefit-risk balance.
• Methods: observational studies, real-world data analysis, user surveys, and continuous literature review.

This information is integrated into the PSUR and the periodic update of the clinical evaluation.

Benefit confirmation — continuity with legacy evidence

The Plus post-market programme takes as direct input the three declared clinical benefits (7GH Diagnostic accuracy; 5RB Objective severity assessment; 3KX Care pathway optimisation), which were validated in routine clinical practice on the equivalent legacy device through the pre-specified co-primary endpoints B2, C4 and D4 of the cross-sectional observational PMS study (R-TF-015-012, analysis set N = 56). All three co-primary endpoints were MCID-positive under Holm-Bonferroni family-wise α = 0.05 control; six pre-specified supportive quantitative endpoints (B4, B6, C5, D2, D6, D7) also exceeded their MCIDs. The per-benefit results were consolidated in R-TF-007-003 § 4.7 and appraised in R-TF-015-003 Clinical Evaluation Report § R-TF-015-012.

The Plus PMCF activities documented in R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan continue benefit-confirmation monitoring for all three benefits at least at the legacy cadence, with design improvements that address the legacy study's acknowledged residual uncertainties (routed to specific PMCF objectives in R-TF-007-002 § Residual uncertainties from legacy PMS: confirmation in PMCF):

• Benefit 7GH (Diagnostic accuracy) — continued via PMCF Activities A.1, A.2, A.3 (triage / malignancy prioritisation / referral adequacy across teledermatology and primary-care workflows), C.1 (image-based diagnosis non-interventional performance analysis across 346 ICD-11 categories), C.2.1–C.2.3 (FDA-parity enriched-dataset standalone sensitivity, MRMC second-read, reproducibility), D.1 (autoimmune diseases prospective surveillance) and D.2 (genodermatoses passive surveillance).
• Benefit 5RB (Objective severity assessment) — continued via PMCF Activities B.1, B.2, B.3, B.4, B.5 (prospective ICC against expert consensus across FFA, acne, atopic dermatitis, vitiligo and hidradenitis suppurativa on device-captured images, independently measurable outcomes).
• Benefit 3KX (Care pathway optimisation) — continued via PMCF Activities A.1, A.2 (waiting-time reduction confirmation), A.3 (referral-adequacy confirmation and remote-care enablement), with site-level before-and-after workflow comparisons embedded in the activity designs.

No new benefits are introduced in the Plus post-market programme; the legacy evidence confirms the benefit-risk argument, and the PMCF activities strengthen it with prospective, independently-measurable outcomes (MDCG 2020-6 § 6.3). Severity-assessment Pillar 3 evidence was already pre-certification-addressable through the four published peer-reviewed severity-validation studies (APASI_2025, AUAS_2023, AIHS4_2023, ASCORAD_2022) supplemented by the preliminary AIHS4_2025 result; the Plus PMCF activities B.1 – B.5 therefore strengthen the pre-market severity position rather than first-establish it — the same confirm/strengthen discipline applies across 7GH, 5RB and 3KX and is not a §6.4 pre-cert gap-filling exercise.

Planned PSUR

For a class IIb device, a Periodic Safety Update Report (PSUR) will be prepared in accordance with Article 86 of MDR 2017/745 and following the recommendations of MDCG 2022-21 and related guidance documents. The PSUR will be updated at least every year and will summarize and analyze the results of the post-market surveillance activities described in this plan.

The PSUR will include:

• Confirmation of the benefit/risk determination
• Identification of new risks or trends
• Any changes to the clinical evaluation
• Actions taken or planned to ensure the continued safety and performance of the device
• Summary of vigilance activities (including serious incidents, FSCA, and trend reporting)
• Summary of PMCF activities and results
• Conclusions and recommendations for risk management and clinical evaluation

The PSUR will be prepared in accordance with the structure and content recommended by MDCG 2022-21. When EUDAMED becomes fully functional, the PSUR will be submitted through the EUDAMED database as required. Until then, the PSUR will be made available to the notified body and competent authorities upon request, as required by the regulation and guidance.

Detailed regulatory traceability

This section provides sub-clause level traceability for the regulatory requirements referenced in the Annex III 1(b) mapping table above.

Article 83 — Post-market surveillance system

• Article 83(1): Obligation to plan, establish, document, implement, maintain and update a PMS system proportionate to the risk class and integrated in the quality management system — addressed in this PMS Plan (R-TF-007-001) and GP-007 Post-market surveillance, § Post-market surveillance system.
• Article 83(2): PMS system shall be suited to actively and systematically gather, record and analyse relevant data on the quality, performance and safety of the device throughout its entire lifetime, and to draw necessary conclusions and determine, implement and monitor preventive and corrective actions — addressed in GP-007, § Post-market surveillance system; § Active monitoring of the information received; GP-020 Data analysis, § Data analysis procedure.
• Article 83(3): PMS data shall be used, in particular, to update the benefit-risk determination and risk management, the design and manufacturing information, the IFU and labelling, the clinical evaluation, and the summary of safety and clinical performance; to identify needs for preventive, corrective or field safety corrective action; to identify options to improve usability, performance and safety; to contribute where relevant to the PMS of other devices; and to detect and report trends in accordance with Article 88. The technical documentation shall be updated accordingly — addressed in this PMS Plan, § Indicators and threshold values for benefit-risk reassessment; § Update risk management file; GP-015 Clinical evaluation; GP-006 Non-conformities, Corrective and preventive actions, § Corrective and Preventive Actions (CAPA); GP-004 Vigilance system, § Trend report; PSUR.
• Article 83(4): Where, in the course of PMS, a need for preventive or corrective action is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body; serious incidents and FSCAs shall be reported in accordance with Article 87 — addressed in GP-006 Non-conformities, Corrective and preventive actions, § Corrective and Preventive Actions (CAPA); GP-004 Vigilance system, § Notification to Regulatory Authorities; § Field Safety Corrective Action (FSCA); SP-004-001 Product withdrawal, § Procedure.

Article 86 — Periodic safety update report

• Article 86(1): Manufacturers of class IIa, IIb and III devices shall prepare a PSUR summarising the results and conclusions of the analyses of the PMS data, together with a rationale and description of any preventive and corrective actions taken — addressed in GP-007, § Periodic Safety Update Report (PSUR); the structure follows MDCG 2022-21 guidance.
• Article 86(2): The PSUR shall be updated at least annually for class IIb devices — the PSUR is prepared annually as stated in this PMS Plan, § Planned PSUR.

Article 87 — Reporting of serious incidents and field safety corrective actions

• Article 87(1): Obligation to report serious incidents to the competent authority of the Member State in which the incident occurred — addressed in GP-004 Vigilance system, § Criteria to notify an incident to the national competent authorities.
• Article 87(2): Reporting timeframes: no later than 15 calendar days for serious incidents, 10 calendar days for death or unanticipated serious deterioration, and 2 calendar days for serious public health threats — addressed in GP-004 Vigilance system, § Timelines for initial communication of incidents.
• Article 87(7): Content requirements for the manufacturer's report — addressed in GP-004 Vigilance system, § Notification to Regulatory Authorities, using the Manufacturer Incident Report (MIR) format per MEDDEV 2.12-1 rev.8.
• Article 87(8): Follow-up reports when investigation exceeds the initial reporting period — addressed in GP-004 Vigilance system, § Incidents occurred in Spain (follow-up report submission to the NCA when the investigation exceeds the period established in the initial report).
• Article 87(9): Final report detailing investigation results and actions taken — addressed in GP-004 Vigilance system, § Notification to Regulatory Authorities (final report using MIR format, detailing actions such as absence of measures, additional control, preventive actions, and FSCAs).
• Article 87(11): Field safety corrective actions and field safety notices — addressed in GP-004 Vigilance system, § Field Safety Corrective Action (FSCA); § Field Safety Notice (FSN).

Article 88 — Trend reporting

• Obligation: Report any statistically significant increase in the frequency or severity of non-serious incidents or expected undesirable side-effects that could have a significant impact on the benefit-risk analysis — addressed in GP-004 Vigilance system, § Trend report.
• Observation period: Annual, aligned with the PSUR cycle, with quarterly interim reviews of quality indicators. Multi-year comparisons are performed at each annual management review. See § Trend analysis, above.
• Statistical method: Comparison with historical data using statistical and comparison techniques per GP-020 Data analysis, § Data analysis procedure. A 25% increase over historic or foreseeable data constitutes the threshold for triggering a formal investigation. See § Indicators and threshold values for benefit-risk reassessment, above.
• Reporting format: MEDDEV 2.12-1 rev.8 Annex VII: Manufacturer's trend report form, as referenced in GP-004 Vigilance system, § Trend report.

Annex XIV — Clinical evaluation and post-market clinical follow-up

Annex XIV Part A — Clinical evaluation

The PMS system integrates with the clinical evaluation process as follows:

• Clinical literature is reviewed annually by JD-005 as part of PMS activities (see § Clinical literature review, above), and the results feed into the clinical evaluation per GP-015 Clinical evaluation.
• All relevant findings from PMS and PMCF activities — including new risks, changes in frequency or severity, and emerging safety signals — are systematically reviewed and incorporated into the T-015-003 Clinical Evaluation Report (see § Update risk management file, above).
• PMS data is compared with previous clinical data, evaluating the contribution of new information, as described in 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 of MDR 2017/745, as described in § PMCF activities above. The PMCF evaluation report is prepared in accordance with Article 86 and Annex XIV Part B, Section 5.

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 & Person Responsible for Regulatory Compliance (PRRC)
• Approver: JD-001 General Manager

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