Guidance on Vigilance Reporting for CE-Marked Devices: An Overview

·         Purpose: The MDCG 2024-1 document provides detailed guidance on the vigilance system applicable to manufacturers of CE-marked devices, aiming for harmonization across reporting practices.

·         Reporting Requirements: Clarifies what constitutes a reportable incident, including individual serious incidents, periodic summary reports, and trend reporting, to ensure manufacturers meet their obligations under the MDR/IVDR.

·         Examples and References: Includes practical examples of non-reportable cases, alongside references to clinical guidelines and the IMDRF terminologies for adverse event reporting, aiding manufacturers in compliance.

🔗 Original: https://health.ec.europa.eu/document/download/dbd0d748-d646-4274-afaa-399952809389_en?filename=mdcg_2024-1_en.pdf