Head of Medical Devices Department Spanish Agency for Medicines and Medical Devices (AEMPS), Spain
Description: Post-market surveillance serves as a vital mechanism for tracking the real-time performance and safety of medical devices once they are in use. Initial tests and investigations are incredibly insightful but do not always capture the full spectrum of potential issues in diverse, everyday environments.
This ongoing monitoring is critical to validating medical devices’ practical safety and utility. It provides a pathway for manufacturers to receive and integrate user feedback, crucial for refining and advancing their products. Beyond enhancing device quality, this surveillance is essential for regulatory compliance.
In this session we will explore prospectives of regulators and industry on the post-market surveillance activities and Eudamed data base, challenges such as a risk of product shortages, that MDR brings, and recommendations from a regulator and industry representatives on the best practices.
