Guidance for Vigilance Reporting on Coronary Stents and Delivery Systems

·         Overview: MDCG 2024-1-2 offers guidance for manufacturers on vigilance reporting of coronary stents and their associated delivery systems.

·         Reportable Events: Details what constitutes a serious incident, including device-related malfunctions and health complications, and how to report them in compliance with MDR.

·         Examples and Reporting Frequency: Provides examples of specific incidents related to coronary stents and outlines the frequency for periodic summary and trend reports.

·         References and Guidelines: Includes clinical guidelines and references for further clarification, alongside IMDRF terminologies for adverse event reporting.

🔗 Original: https://health.ec.europa.eu/document/download/6bfe418c-b72e-4e8a-b7e3-7aa1d0060da8_en?filename=mdcg_2024-1-2_en.pdf