Guidance for Reporting Incidents with Cardiac Implantable Electronic Devices (CIEDs)

5 Apr

Written By MDRG

MDCG 2024-1-3 provides guidance for manufacturers on vigilance reporting for Cardiac Implantable Electronic Devices (CIEDs), including what constitutes a serious incident, how to conduct periodic summary reporting, and when to identify and report trends. This document aligns with MDR requirements and offers examples of incidents related to CIEDs, aiming to enhance the harmonization of vigilance reporting.

🔗 Original: https://health.ec.europa.eu/document/download/c1e34b32-4faf-4ea5-af66-959642148b3a_en?filename=mdcg_2024-1-3_en.pdf

MDRG

Guidance for Reporting Incidents with Cardiac Implantable Electronic Devices (CIEDs)

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