Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics

This document offers a comprehensive guide on the monitoring and evaluation of medical devices after they've been introduced to the market, known as post-market surveillance. It emphasizes the importance of collecting and analyzing user experiences to ensure the continued safety and efficacy of these devices. The guidance delineates the roles and responsibilities of various stakeholders, including manufacturers and National Regulatory Authorities (NRAs). It covers the processes of gathering feedback, reporting incidents, and taking corrective actions. Additionally, the document aligns with international standards set by organizations like the World Health Organization (WHO) and discusses the evolving landscape of regulations and standards in the medical device industry. The guidance also underscores the significance of user feedback in enhancing device performance and safety.