arcoro Glossar

Vigilance system

A vigilance system is a monitoring and reporting system for medical devices that is demanded by the MDR. As a reactive security concept, it is intended to supplement the general market surveillance of conformity assessments prior to the market launch of medical products and thereby offer greater security for users and patients. The underlying intent of vigilance systems is an efficient risk management. Due to the limited informative value of clinical evaluations and tests of a newly introduced medical device and the resulting higher risk of subsequent problems in broad application, the information stored in the system and the knowledge gained in the following should avoid comparable problems with similar products from other manufacturers and thus, higher security standards can be achieved.