[Medical device surveillance]. / La matériovigilance.

ABSTRACT

The medical device vigilance system was set up in France in line with European directives. It consists of reporting of incidents or risks of incidents related to medical devices, evaluation of information, follow-up of files and conduct of device safety studies. Health establishments must appoint a local medical device vigilance correspondent responsible for sending declarations to the ministry. The Ministry of Health centralizes and evaluates the various declarations. The national medical device vigilance commission and the eight technical subcommittees consequently play an advisory role to the Minister of Health. When decided by the Minister, manufacturers of medical devices for which a declaration has been submitted may be required to modify them or withdraw them from the market. Medical device vigilance is therefore now an integral part of clinical practice.