ISO 13485 (Clause 8.2) - EU Vigilance and Reporting to the Regulatory Authorities Procedure

Ensure your organization’s vigilance procedures and reporting processes are fully compliant with EU medical device regulations using our ISO 13485:2016 Clause 8.2 EU Vigilance and Reporting to the Regulatory Authorities Procedure Template. Post-market surveillance and vigilant reporting are crucial for maintaining device safety, performance, and regulatory compliance. This ready-to-use template provides a clear, structured process for handling adverse events, device incidents, and regulatory reporting to EU authorities, including the European Medicines Agency (EMA) and national Competent Authorities.

✔ Pre-Formatted Vigilance & Reporting Procedure – Fully aligned with ISO 13485:2016 Clause 8.2 and EU regulatory requirements.
✔ Incident Identification & Assessment – Establish procedures for identifying and evaluating adverse events, serious incidents, and product defects.
✔ EU Reporting Requirements – Ensure compliance with EU MDR 2017/745 for timely reporting to Competent Authorities and the European Commission.
✔ Corrective Actions & Risk Mitigation – Define CAPA (Corrective and Preventive Actions) based on incident findings.
✔ Audit-Ready Documentation – Maintain traceable, comprehensive records for audits and inspections.
✔ Editable Digital Format – Customizable to suit various device types and vigilance protocols.

This EU vigilance and reporting procedure template is ideal for regulatory affairs teams, quality managers, and compliance officers, ensuring a compliant, efficient reporting process.

Download the ISO 13485:2016 EU Vigilance and Reporting Procedure Template today and streamline your regulatory compliance and post-market surveillance efforts!