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Risk Class Justification – CardioMonitor Pro ECG-12

1. Device Classification

1.1 Assigned Risk Class

Medical Device Class: IIa (per EU MDR 2017/745 Annex VIII)

1.2 Regulatory Basis

  • MDR 2017/745: European Medical Device Regulation
  • IEC 62304: Medical device software lifecycle processes
  • IEC 60601-1: General safety requirements for medical electrical equipment
  • IEC 60601-2-25: Particular requirements for ECG equipment

2. Classification Rules (MDR Annex VIII)

2.1 Applicable Rule

Rule 10: Active devices for diagnosis and monitoring are Class IIa unless intended to monitor vital physiological parameters where variations could result in immediate danger, or for diagnosis in life‑threatening clinical situations (then Class IIb).

2.2 Classification Rationale

CardioMonitor Pro ECG-12 is Class IIa because:
1. Active diagnostic device: Performs cardiac diagnostic acquisition & interpretation.
2. Not continuous vital monitoring: Designed for discrete short examinations, not continuous surveillance of vital parameters.
3. Not primary use in acute life‑threatening scenarios: Supplementary diagnostic tool, not sole device in critical resuscitation.
4. Routine diagnostic context: Typical use in standard cardiology & preventive screening.

3. Risk Profile per Criteria

3.1 Functional Risk

Assessment: Moderate
Justification: ECG data influences clinical decisions; single measurement errors rarely immediately life‑threatening; ECG is one of several diagnostic inputs.

3.2 Energy / Electrical Safety

Assessment: Low
Characteristics:
- Patient leakage current <10 µA (well below limits)
- No therapeutic energy delivery
- BF applied part compliance (IEC 60601‑1)
- Galvanic isolation for shock protection

3.3 Invasiveness

Assessment: None
Non‑invasive surface electrodes; no penetration; reversible at any time.

3.4 Duration of Use

Assessment: Low
Short, intermittent sessions (seconds to minutes); no cumulative exposure effects.

4. Comparable Devices & Precedent

4.1 Market Comparison (Class IIa ECG Devices)

  • Established multi‑lead diagnostic ECG systems
  • Portable practice cardiographs
  • Digital ECG units without continuous monitoring capability

4.2 Regulatory Precedents

  • FDA: Class II (21 CFR 870.1025)
  • MDCG Guidance: Confirms IIa classification for diagnostic ECGs
  • Notified Bodies: Consistent EU classification outcomes

5. Technical Safety Measures

5.1 Electrical Safety

IEC 60601‑1 conformity: BF applied part, EMV compliance, shock protection, mechanical enclosure integrity.

5.2 Software Safety

IEC 62304 classification: Predominantly Class B modules; safety‑related algorithm controls & integrity checks may elevate subcomponents. Structured lifecycle, documented risk management, verification & validation of all safety functions.

5.3 Usability Safety

IEC 62366 applicability: Clear labeling, intuitive UI, minimized user error potential, comprehensive IFU.

6. Clinical Evidence & Post‑Market Monitoring

6.1 Clinical Evaluation

Demonstrated technical & clinical equivalence to marketed ECG systems; literature review; comparative performance studies; validated diagnostic accuracy metrics.

6.2 Post‑Market Follow‑Up (PMCF)

Systematic collection of field performance, adverse event surveillance, periodic safety update reports (PSUR), continuous benefit‑risk reassessment.

7. Quality Management System

7.1 QMS Requirements (Class IIa)

ISO 13485 certified full QMS; notified body audits; documented design controls.

7.2 Conformity Assessment Path

Annex IX route: Quality system assessment or EU type examination; CE marking upon successful conformity; EUDAMED registration.

8. Classification Conclusion

8.1 Confirmation of Class IIa

Justified through:
1. Rule 10 applicability
2. Acceptable moderate functional risk
3. Adequate technical safety controls
4. Market conformity with peer devices
5. Positive benefit–risk profile.

8.2 Regulatory Implications (Required Measures)

  • ✅ Notified body conformity assessment
  • ✅ CE marking
  • ✅ ISO 13485 QMS
  • ✅ Clinical evaluation per MDR
  • ✅ Post‑market surveillance system
  • ✅ EUDAMED registration

8.3 Ongoing Classification Review

Triggered by changes in intended use, technical modifications, new regulatory requirements, or post‑market findings.

Document Status: Effective from 2025-09-24
Version: 1.1.0 - Gültig ab: 17. November 2025- Erstellungsdatum: 17. November 2025- Letzte Überarbeitung: 17. November 2025Next Review: 2026-09-24

  • Letzte Überarbeitung: 19. November 2025Approved by: Regulatory Affairs Manager

  • Nächste Überprüfung: 19. November 2026Quality Assurance: ISO 13485 QMS

Anhang D: Änderungshistorie

Datum Version Autor Änderungen
19. November 2025 1.1.0 Unbekannt Automatische Metadatenaktualisierung
17. November 2025 1.0.1 Unbekannt Automatische Metadatenaktualisierung