Medtech Post-market essentials

Post-market surveillance planning and reporting is a new motion for many medtech regulatory affairs teams. Unclear and inconsistently enforced requirements have allowed companies to support a wide range of approaches. The transition to EU MDR/IVDR regulations, however, has brought many of these vague requirements into sharp relief. We will discuss the elements of effective post-market surveillance plans, reporting requirements for different product types and risk classes, and strategies to increase collaboration between regulatory and quality teams.