Guidance on Vigilance for Cardiac Ablation Devices: Key Insights

·         Purpose: Provides harmonized vigilance reporting guidelines for manufacturers of cardiac ablation devices, in line with MDR [1] requirements.

·         Key Reporting Categories: Highlights when to report individual serious incidents, engage in periodic summary reporting, and identify trends needing attention.

·         Examples Provided: Offers specific examples of incidents related to cardiac ablation devices, aiding manufacturers in determining reportability.

·         Further Resources: Includes references to clinical guidelines and IMDRF terminologies for accurate adverse event reporting.

🔗 Original: https://health.ec.europa.eu/document/download/e170bdf5-1684-4e24-bfbc-ec34b1ea1b4f_en?filename=mdcg_2024-1-1_en.pdf