MDR reporting obligations, complaint handling as an engineering process, post-market clinical follow-up under EU MDR, and recall classification.
Regulatory clearance is a starting line, not a finish line: premarket clinical and bench evidence is inherently limited by smaller study populations, shorter follow-up, and controlled-site use conditions that never fully capture real-world deployment, and this module builds the postmarket surveillance obligations that close that gap — Medical Device Reporting to FDA under 21 CFR 803, and complaint handling run as a rigorous engineering process rather than a customer-service function.
It then covers Post-Market Clinical Follow-up under EU MDR, field corrective actions and recall classification, and trend analysis that closes the loop directly back to the risk management file from Module 3 — a field failure pattern is exactly the kind of new information ISO 14971 requires a manufacturer to evaluate against previously accepted residual risk.