Comparative analysis of medical device adverse event reporting forms for patients and industries across various countries, and the introduction of a unified generic form for harmonization.

Abstract

This comparative study examines the complexities of adverse event reporting forms for medical devices across various nations. Despite rigorous clinical trials and surveillance techniques, variations persist in processes and data elements used to report adverse events. The study highlights the importance of standardizing adverse event reporting for medical devices and suggests a comprehensive 'Generic Adverse Event Reporting Form' to accurately determine causality. The advice encourages widesprea