FAYEZ ABOU HAMAD
Terumo Europe, Leuven, Belgium

Abstract

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).