MEDICAL DEVICE
VIGILANCE FORM
At TOLLEON, we strictly adhere to and implement all European and National Guidelines related to Material Vigilance Systems, providing our partner companies with comprehensive updates on the required system and the mandatory use of the White Card.
At TOLLEON, we strictly adhere to and implement all European and National Guidelines related to Material Vigilance Systems, providing our partner companies with comprehensive updates on the required system and the mandatory use of the White Card.
Upon agreement, TOLLEON provides:
- The preparation and development of a Material Vigilance System, including the Corrective Actions System (customer list, recommended corrective actions/FSCA, execution timeline, sample Safety Notice Letter/FNS with customer acceptance form and response sheet).
- Training on Material Vigilance and the White Card system for involved safety personnel to ensure proper handling of any adverse events.
- Compilation of the Initial Incident Report for submission to the responsible national authority.
- The Investigation of incidents and submission of Follow-up Reports.
- Final Report submission to the national regulatory body and summary feedback to the reporting user.
- Supervision of the implementation of the Corrective Safety Action System (FSCA).
- Secure storage for and record-keeping of adverse incidents.
- Preparation of Periodic Summary Reports.
- Drafting and/or reviewing Material Vigilance Agreements for medical devices.
- The assessment of reports based on frequency, medical significance, and root causes.
- The establishment of Prevention/Corrective Action Procedures for potential safety profile changes and corrective measures (e.g., updates to instructions for use, labeling and warnings, depending on the nature and frequency of SUEs).
- The maintenance of a clear and defined Traceability Process.
- Written procedures with practical and functional aspects to ensure the timely execution of product withdrawal, replacement, or recall, whether by regulatory demand or company decision due to serious safety concerns, mislabeling, or poor product quality.
TOLLEON safeguards product safety through a fully compliant Material Vigilance System, aligned with EU and national standards. From White Card training and incident reporting to investigation, corrective actions, and recalls, we manage the entire process with precision and regulatory expertise. Our proactive monitoring, documentation, and traceability ensure your medical devices remain trusted, compliant, and safe in the market.