AET Training and Guidance Documents
Aligned with the IMDRF 2021-2025 Strategic Plan, IMDRF is enhancing efforts to promote regulatory convergence. A key strategy to achieve this is the creation of training programs and materials designed to ensure consistent understanding and implementation of IMDRF technical documents.
Adverse event reporting enables the monitoring of medical devices in use, their performance in the real world and identify trends that may indicate emerging safety and performance issues.
Understanding Adverse Event Reporting and using the correct terminology is an essential part of monitoring medical devices on the market and ensuring that any post-market issues and incidents are appropriately reported. This training is intended for regulatory authorities, manufacturers, and healthcare institutions.