Class D — High Risk Devices
Definition
Class D devices present the highest level of risk and correspond to EU MDR Class III. Examples include active implantable cardiac devices (pacemakers, defibrillators), heart valves, vascular grafts, total joint replacement systems, and HIV diagnostic tests (IVD).
MDMA pathway
Class D requires the most extensive technical documentation, including:
- Comprehensive clinical investigation data or justification for equivalence
- Full risk management (ISO 14971) with residual risk justification
- Detailed pre-clinical testing (biocompatibility, sterility, mechanical testing)
- Clinical Evaluation Report (CER) with long-term follow-up strategy
QMS and mandatory audit
SFDA typically requires an on-site inspection and audit of Class D manufacturer QMS facilities. This is in addition to ISO 13485 certification from a CAB or IAF-accredited CB. Manufacturers of Class D devices should expect SFDA direct engagement throughout the review process.
Post-market for Class D
Class D devices require an annual PSUR, updated with:
- Comprehensive PMS data from all available sources
- Risk-benefit determination
- PMCF study results
- Sales volume and distribution data
- Adverse event analysis and CAPA summary