Surveillance system
For each product, the manufacturer shall plan, establish, document, implement, maintain and update a post-market monitoring system proportional to the risk class and type of the product. Such a system shall be an integral part of the manufacturer’s quality management system.
The system shall be suitable for actively and systematically collecting, storing and analysing data on the quality, performance and safety of a product throughout its life cycle, and shall be able to draw the relevant conclusions, determine, implement and monitor any preventive and/or corrective action.
The data collected will be used to:
- Improve the determination of the risk-benefit ratio and risk management of the product.
- Update information on design, manufacturing, instructions for use and labelling.
- Update the clinical assessment.
- Update the safety and operation summary.
- Detect the need for preventive or corrective actions.
- Determine possible improvements in the use, operation and safety of the product.
- Contribute to the monitoring of other products, where appropriate.
- Detect trends and report on them.
The technical documentation shall be kept updated accordingly and the competent authority shall be notified of the occurrence of any incident.
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