·         Objective: Establishes standardized vigilance reporting for breast implant manufacturers, aligning with MDR requirements.

·         Reporting Focus: Emphasizes the importance of reporting individual serious incidents, conducting periodic summary reporting, and recognizing trend reporting.

·         Incident Examples: Lists specific examples of incidents related to breast implants that necessitate reporting, enhancing manufacturer awareness.

·         Additional Resources: Guides manufacturers to clinical references, IMDRF terminologies, and provides essential links for further guidance.

🔗 Original: https://health.ec.europa.eu/document/download/07c958e3-c2c7-4a22-82f1-86ab2debf40e_en?filename=mdcg_2024-1-4_en.pdf