Reporting to Regulatory Authorities Procedure - ISO 13485

Ensure regulatory compliance and effective incident reporting with our ISO 13485:2016 Clause 8.2 Reporting to Regulatory Authorities Procedure Template. Timely and accurate reporting of adverse events, non-conformities, and post-market surveillance findings is essential for maintaining compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 803. This structured procedure template provides a clear framework for identifying reportable events, determining regulatory obligations, and ensuring proper submission of reports to relevant authorities.

✔ Pre-Formatted Reporting Procedure – Covers key ISO 13485:2016 Clause 8.2 and regulatory requirements.

✔ Incident Classification & Reportability Assessment – Determine which events require regulatory reporting.

✔ Regulatory Reporting Timelines & Requirements – Ensure compliance with MDR vigilance reporting, FDA MedWatch, and global requirements.

✔ Investigation & Root Cause Analysis Guidelines – Align with ISO 14971 risk management principles.

✔ Corrective & Preventive Action (CAPA) Integration – Ensure proper follow-up and resolution.

✔ Approval & Submission Workflow – Assign responsibilities for report creation, review, and submission.

✔ Audit-Ready Documentation – Maintain structured records for regulatory inspections.

✔ Editable Digital Format – Fully customizable for different medical device classifications and global markets.

This ready-to-use regulatory reporting procedure is ideal for quality managers, regulatory teams, and compliance officers, ensuring a structured, compliant, and efficient reporting process.

Download the ISO 13485:2016 Reporting to Regulatory Authorities Procedure Template today and improve your regulatory compliance and vigilance system!