Vigilance system
A vigilance system ( Latin vigilantia , 'alertness', 'cunning') is a monitoring and reporting system, the establishment of which is prescribed by European law , in particular by European medical device law .
The vigilance system covers all stages of market monitoring in traffic accommodated medical devices by the manufacturer or importer , monitoring and evaluation of all incidents, which reports to the authorities and the security such. B. Recalls. Furthermore, the vigilance system includes all information levels of the national authorities, their briefing among themselves, their risk assessment and other actions to avert danger.
In the Federal Republic of Germany, reports by the manufacturer to the authorities are made exclusively via online forms, which are administered by the German Institute for Medical Documentation and Information (DIMDI).
In the Federal Republic of Germany, the higher authority of the vigilance system is the Federal Institute for Drugs and Medical Devices (BfArM).
The Medicines and Healthcare products Regulatory Agency (MHRA) developed recommendations on vigilance systems for medical devices in Europe (MEDDEV 2.12 / 1 rev 5).
