These guidelines describe the European system for the notification and evaluation of Incidents and FIELD SAFETY CORRECTIVE ACTIONS(FSCA)involving Medical Devices,known as the Medical Devices Vigilance system.
The principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients,Users and others by reducing the likelihood of reoccurrence of the INCIDENT elsewhere,This is to be achieved by the evaluation of reported Incidents and,where appropriate,dissemination of information,which could be used to prevent such repetitions,or to alleviate the consequences of such Incidents.
These guideline are intended to facilitate the uniform application and implementation of the Medical Device Vigilance System requirements contained within:
- the Directive for Active Implantable Medical Device(AIMD),90/385/EEC
- the Directive for Medical devices(MDD),93/42/ECC
- the In Vitro Diagnostic Medical Devices Directive(IVDD),98/79/EC.
FIELD SAFETY CORRECTIVE ACTION (FSCA),FIELD SAFETY NOTICE(FSN),USE ERROR and ABNORMAL USE are new concepts introduced in this revision of the guideline to enhance and clarify the European Medical Device Vigilance System while promoting harmonization with GHTF provisions.
The Medical Device Vigilance System is intended to facilitate a direct,early and harmonized implementation of FIELD SAFETY CORRECTIVE ACTION across the Member States where the device is in use,in contrast to action taken on a country by country basis.
Corrective action includes,but may not be confined to:a device recall;the issue of a FIELD SAFETY NOTICE; additional surveillance/modification of devices in use;modification to future device design,components or manufacturing process;modification to labeling or instructions for use.