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

Ensure that your organization meets the UK vigilance and reporting requirements with our ISO 13485:2016 Clause 8.2 UK Vigilance and Reporting to the Regulatory Authorities Procedure Template. Post-market surveillance and reporting are critical for the ongoing safety and performance monitoring of your medical devices. This ready-to-use template provides a structured framework for managing vigilance activities and ensuring compliance with UK regulations, including timely reporting of adverse events and incidents to the relevant regulatory authorities.

✔ Pre-Formatted Vigilance & Reporting Procedure – Aligned with ISO 13485:2016 Clause 8.2 and UK regulatory requirements.
✔ Vigilance Process Overview – Define the steps for identifying, assessing, and reporting adverse events and device-related incidents.
✔ Reporting Guidelines – Ensure compliance with UK regulations, including timing, format, and required documentation for reporting to the MHRA.
✔ Incident Evaluation & Risk Assessment – Implement procedures for evaluating risks associated with reported incidents and determining necessary corrective actions.
✔ Corrective Actions & Preventive Measures (CAPA) – Establish corrective actions and preventive measures based on the incident analysis.
✔ Audit-Ready Documentation – Maintain well-organized records for audits, inspections, and regulatory reviews.
✔ Editable Digital Format – Fully customizable for various medical device types and reporting requirements.

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

Download the ISO 13485:2016 UK Vigilance and Reporting Procedure Template today to streamline your vigilance process and regulatory compliance!