Class C — Medium-High Risk
Definition and Scope
Class C devices present a medium to high risk and require an enhanced registration dossier with substantive clinical evidence and robust conformity assessment. These are typically long-term invasive devices or devices supplying significant energy to the body.
Classification Criteria
A device is typically Class C when it:
- Is a long-term invasive device (implanted for > 30 days) other than Class D
- Is active and intended to diagnose, monitor, or supply energy for therapeutic purposes in a potentially hazardous manner
- Delivers ionising radiation
- Has a biological effect (e.g. bioresorbable implants)
- Is intended for use in direct cardiac contact (non-Class D)
- Is a blood bag or central vascular catheter
Class C Examples
| Product | Notes |
|---|---|
| Long-term urinary catheters (>30 days) | Long-term invasive |
| Bone fixation plates and screws | Long-term implantable |
| Haemodialysis systems | Extracorporeal blood circuit |
| Lung ventilators | Life-supporting but not Class D |
| Diagnostic X-ray machines | Delivers ionising radiation |
| Drug infusion pumps | Active, life-sustaining adjacent |
| Intraocular lenses (IOLs) | Long-term implantable |
| Vascular grafts (non-cardiac) | Long-term implantable |
| Mammography systems | Ionising radiation diagnostic |
| Infusion pumps | Active, medication delivery |
Registration: Enhanced Dossier
In addition to all Class B requirements, Class C dossiers must include:
Enhanced Technical Documentation
- Full risk management file (ISO 14971) — not just summary
- Complete clinical evaluation report (CER) per GHTF SG5/IMDRF MDCE WG
- Post-market clinical follow-up (PMCF) plan
- Summary of safety and performance (SSP) if available
Clinical Evidence Requirements
- Clinical data from clinical investigations and/or literature
- Demonstration of clinical benefit
- Acceptable benefit-risk profile
- Equivalence justification (if relying on equivalent device data)
Conformity Assessment
- ISO 13485 QMS certificate
- Third-party review of technical documentation by a recognised Conformity Assessment Body (CAB) for Class C
Processing Timeline
Target: 120 working days from acceptance of complete application.
Clinical Data is Critical
MDA scrutinises clinical evidence for Class C devices carefully. Insufficient clinical data is a leading cause of rejections. Ensure your Clinical Evaluation Report is comprehensive, current, and product-specific.