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Class C — Full Registration

Overview​

Class C requires an enhanced registration dossier with substantive clinical evidence in addition to all Class B requirements. A third-party Conformity Assessment Body (CAB) review of technical documentation is required. Target processing time is 120 working days.

Additional Requirements vs Class B​

Full Clinical Evaluation Report (CER)​

The CER must comply with GHTF SG5 / IMDRF MDCE WG guidance and include:

  • Systematic literature search and appraisal
  • Clinical data from relevant clinical investigations
  • Demonstration of clinical benefit
  • Acceptable benefit-risk analysis
  • Equivalence justification (if applicable, with full equivalence documentation)

Post-Market Clinical Follow-Up (PMCF) Plan​

  • Plan for collecting ongoing clinical data after registration
  • Frequency and methodology of PMCF activities
  • Integration with the overall PMS plan

Conformity Assessment Body (CAB) Review​

For Class C devices, the technical documentation must be reviewed by a MDA-recognised CAB before submission:

  • CAB issues a Technical Documentation Assessment Report
  • This report is submitted as part of the registration dossier
  • CAB review is separate from QMS certification (ISO 13485)

Recognised CABs include international notified bodies and testing organisations recognised by MDA. Check the current MDA-recognised CAB list on the MDA website.

Enhanced Risk Management File​

  • Full risk management file (not summary) — ISO 14971 compliant
  • Risk management report
  • Post-production information procedures

Full Dossier Structure​

Class C includes all Class B sections plus:

Additional SectionContent
Full Clinical Evaluation ReportPer GHTF SG5 / IMDRF MDCE WG
PMCF PlanPer IMDRF MDCE WG/N56
CAB Technical Documentation AssessmentFrom MDA-recognised CAB
Full Risk Management FileISO 14971 compliant file
Biological Safety EvaluationFull ISO 10993 reports (not just summary)

Practical Considerations​

Engage CAB Early

CAB review can take 3–6 months for complex Class C devices. Engage your CAB early in the preparation process — ideally before your full dossier is assembled. Incorporate CAB feedback before submission to MDA.

Clinical Equivalence

If relying on equivalence to an already-marketed device, MDA requires demonstration of:

  1. Clinical equivalence (same intended use and clinical conditions)
  2. Technical equivalence (similar design, dimensions, materials)
  3. Biological equivalence (same materials in contact with body) Full access to the equivalent device's technical documentation is typically required.