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Glossary Term
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Adverse Event (AE) Reporting

Definition

Adverse Event Reporting refers to the process of documenting and submitting information about adverse events (AEs) associated with medical devices to regulatory authorities, such as the FDA or European competent authorities. It involves collecting detailed information about the event, assessing causality, and ensuring timely compliance with reporting requirements.

Relevance to the MedTech Industry

Adverse Event Reporting is vital for maintaining patient safety, regulatory compliance, and public trust. By systematically tracking and reporting AEs, manufacturers can identify potential risks, implement corrective actions, and ensure their devices remain safe and effective throughout their lifecycle.

Additional Information & Related Terms

  • Post-Market Surveillance Tracks and evaluates AEs to ensure continued device safety and efficacy.

  • Risk Management File (ISO 14971) Incorporates AE Reporting data to refine risk assessments.

  • Corrective and Preventive Actions (CAPA) Responds to trends or specific issues identified through AE Reporting.

  • Medical Device Reporting (MDR) Regulatory requirement for reporting AEs in the U.S.

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