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.
Medical device and in vitro diagnostic manufacturers who sell within the European Union are now required to maintain robust post-market surveillance systems and submit periodic safety reports to notified bodies and other regulatory authorities. Adapting to meet these new requirements will require an expanded data strategy, new processes and planning, and a tight alignment between quality and regulatory teams.
Join Rimsys for an interactive panel discussion about MDR/IVDR postmarket requirements, how they’re influencing regulations in other markets, and best practices that companies can adopt to ensure compliance.
-The elements of effective post-market surveillance plans
-Reporting requirements for different product types and risk classes
-Strategies to increase collaboration between regulatory and quality teams