ClinicalCompass — Clinical Evaluation Navigator

1 · Device & Intended Purpose Profiler Foundation — all modules read from this profile

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Device name / model

Previous regulatory history

EU MDR risk classification

FDA classification / pathway

Intended purpose / indications for use

Free-text detail feeds the completeness check below. Completeness is measured here as "field length > 3 characters" — a navigator-level proxy, not a clinical-sufficiency judgment; a short but complete sentence can still pass this check while being clinically insufficient.

Target patient population / condition

Intended users / use environment

Device / technology flags

Novel (not well-established technology) Software / SaMD / AI-enabled Implantable / active implantable / invasive Contains SOUP / OTS software Networked / connected / data-transmitting High use-error risk scenarios present

2 · Clinical Evaluation Strategy Engine EU MDR Art. 61 + Annex XIV · FDA pathway logic

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EU MDR — Article 61(4–6) clinical investigation decision tree

Is the device implantable or Class III?

Yes

Does an Art. 61(4) / 61(6) exception apply? (well-established technology, prior CE-marked equivalent by same manufacturer, sufficient literature per MDCG 2023-7)

Yes — exception applies

No / not established

FDA — pathway clinical data expectation

Driven by the FDA classification/pathway selected in Module 1.

3 · Equivalence Assessment MDCG 2020-5 — three-pillar comparison

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Technical characteristics

Equivalent

Minor differences

Not equivalent

Biological characteristics

Equivalent

Minor differences

Not equivalent

Clinical characteristics

Equivalent

Minor differences

Not equivalent

Does the manufacturer have sufficient access to the equivalent device's technical documentation (MDCG 2020-5 access requirement)?

Sufficient access

Not established

Access is generally internal/straightforward when comparing to the manufacturer's own previously marketed device. The strict contractual/legal-access requirement (written agreement demonstrating the same level of access as if the data were their own — MDCG 2020-5 §D, MDCG 2023-7) applies specifically when claiming equivalence to a third-party competitor device. This field does not distinguish the two — treat "sufficient access" more conservatively for a competitor device.

4 · Clinical Data Sufficiency & Gap Analyzer Evidence hierarchy — inspired by MDCG 2020-6 Appendix III

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Data sources available (check all that apply)

Manufacturer's own clinical data (investigations / PMCF) Literature / published clinical data Equivalent / similar device data Real-world evidence / registries Non-clinical data supporting clinical claims

Claimed clinical benefits / performance / safety endpoints to map data against

6 · PMCF Planning & Report Module MDCG 2020-7 / 2020-8 · Annex XIV Part B

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PMCF methods planned

Post-market surveys / questionnaires Registries Ongoing literature review Specific PMCF study Complaint / vigilance trend analysis

Justification (required if no PMCF method is selected)

7 · SSCP Generator Support MDR Art. 32 · MDCG 2019-9 Rev.1 — Class III / implantable devices

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SSCP sections present

Device identification & intended purpose Intended patient population / users Diagnostic/therapeutic alternatives Summary of clinical evaluation data Residual risks / warnings Patient-facing version considerations

Is the SSCP consistent with CER conclusions?

Consistent

Inconsistent / not yet checked

7b · PSUR & Post-Market Surveillance MDR Art. 83–86, Annex III · MDCG 2022-21

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Applicability and frequency are class-driven and computed automatically from the EU MDR class selected in Module 1: Class I → PMS Report only (no PSUR); Class IIa → PSUR at least every 2 years; Class IIb/III → PSUR at least annually, submitted to the Notified Body via EUDAMED for Class III/implantable (Art. 86(2)).

PMS/PSUR elements present

PMS plan proportionate to risk class (Annex III §1.1) Systematic data collection from multiple sources (complaints, vigilance, literature, registries) Trend analysis / statistical methodology documented Summary of main PMCF findings included (Art. 86(1)) Benefit-risk conclusion updated against PMS data CAPA / preventive-corrective action rationale documented

8 · SaMD / AI Clinical Evaluation Module IMDRF N41 + MDCG 2020-1 · FDA PCCP (§515C) · EU AI Act intersection

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Valid clinical association

Established

Partial

Not established

Analytical validation

Established

Partial

Not established

Clinical validation

Established

Partial

Not established

Does the algorithm continuously learn / adapt post-deployment (locked vs. adaptive)?

No — locked model

Yes — continuous learning / adaptive

FDA — Predetermined Change Control Plan (PCCP)

Required consideration for any AI/ML-enabled device (locked or adaptive) submitting under 510(k)/De Novo/PMA — FDA final guidance, Aug 2025, under FD&C Act §515C.

PCCP elements present (only required if a PCCP will be submitted — locked models may skip)

Description of planned modifications (data, performance, retraining scope) Modification protocol (methodology to develop/validate/implement each change) Impact assessment (benefit-risk of the bounded changes) Aligned with GMLP (Good Machine Learning Practice) 10 guiding principles

EU — AI Act intersection (Reg. (EU) 2024/1689)

Auto-derived from EU MDR classification in Module 1: devices requiring Notified Body involvement (Class IIa and above) are high-risk AI systems under AI Act Art. 6(1)/Annex I when they qualify as AI systems. Compliance deadline (post Digital Omnibus, 2026): 2 August 2028 for Annex I (regulated-product) AI systems.

9 · Human Factors / Usability Linkage IEC 62366-1

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Have critical tasks and use errors been mapped to residual risk?

Yes

Not yet

Is summative usability validation evidence available (required where high-risk use scenarios exist)?

Yes / not applicable

10 · Cybersecurity Considerations in Clinical Evaluation MDCG 2019-16 + FDA cybersecurity guidance

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Cybersecurity items addressed in the clinical evaluation

Cybersecurity-related residual risks identified and linked to clinical performance/safety claims Information for safety / labeling addresses cyber risk (IFU warnings, network requirements) Impact of planned security updates/patches on locked clinical performance claims assessed Cyber-related adverse scenarios considered in the benefit-risk conclusion (not risk-management file alone)

For jurisdiction-by-jurisdiction cybersecurity requirement detail, see the companion CyberCompass tool.

11 · SOUP / OTS Software Clinical Impact IEC 62304

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SOUP risk classification (IEC 62304 §5.1, or 62304 amendment for legacy items)

SOUP/OTS documentation present

SOUP components inventoried Provenance documented Known anomalies reviewed for clinical/safety impact (not just catalogued) Clinical performance/safety impact assessed Residual risk accepted or mitigated, with rationale documented

Live Gap & Sufficiency Status

—completeness

Thresholds (≥75% green / ≥45% amber / below red) are an internal design choice for this navigator, not a regulatory pass/fail line.

Prioritized Action List

Complete the Device Profiler to generate a prioritized, cited action list.

Export

Printing generates the Integrated Clinical Evaluation Master Report (all modules, current status, and citations) in one pass — led by the prioritized action list and overall score.

1 · Device & Intended Purpose Profiler Foundation — all modules read from this profile

2 · Clinical Evaluation Strategy Engine EU MDR Art. 61 + Annex XIV · FDA pathway logic

EU MDR — Article 61(4–6) clinical investigation decision tree

FDA — pathway clinical data expectation

3 · Equivalence Assessment MDCG 2020-5 — three-pillar comparison

Technical characteristics

Biological characteristics

Clinical characteristics

4 · Clinical Data Sufficiency & Gap Analyzer Evidence hierarchy — inspired by MDCG 2020-6 Appendix III

5 · CEP / CER Structure & Completeness Checker MDR Annex XIV Part A + MEDDEV 2.7/1 Rev.4 + MDCG

6 · PMCF Planning & Report Module MDCG 2020-7 / 2020-8 · Annex XIV Part B

7 · SSCP Generator Support MDR Art. 32 · MDCG 2019-9 Rev.1 — Class III / implantable devices

7b · PSUR & Post-Market Surveillance MDR Art. 83–86, Annex III · MDCG 2022-21

8 · SaMD / AI Clinical Evaluation Module IMDRF N41 + MDCG 2020-1 · FDA PCCP (§515C) · EU AI Act intersection

Valid clinical association

Analytical validation

Clinical validation

FDA — Predetermined Change Control Plan (PCCP)

EU — AI Act intersection (Reg. (EU) 2024/1689)

9 · Human Factors / Usability Linkage IEC 62366-1

10 · Cybersecurity Considerations in Clinical Evaluation MDCG 2019-16 + FDA cybersecurity guidance

11 · SOUP / OTS Software Clinical Impact IEC 62304

Live Gap & Sufficiency Status

Prioritized Action List

Export

Integrated Clinical Evaluation Master Report