EU medical device vigilance system – Between now and then – Trend Reporting
The Quality System elements already in place (like complaint handling, risk management and clinical evaluation processes, CAPA system, quality improvement reviews) can be used as a basis for implementation of successful trend reporting and the latter can be used to reinforce the Quality System in a “win-win” situation in which a favorable outcome for all involved elements is achieved without running double systems.
MEDICAL DEVICES DIRECTIVE – TREND REPORT
Medical Devices Directive requires manufacturers to institute and keep up to date procedures in place for systematic review of experience gained from device use in the post-production phase. These review systems are particularly important in helping to ensure the continuing safety of certain device types because their long-term performance cannot reliably be predicted from information obtained from pre-market clinical investigations or short-term use.
In addition, the manufacturer is obliged to notify the competent authorities of the following incidents immediately on learning them: Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead or have led to the death of a patient or user or to a serious degradation of his state of health.
This vigilance system arrangements are described in an European Commission’s guidance (MEDDEV 2.12-1 rev 8, January 2013, Guidelines on a medical devices vigilance system).