Vigilance means "watchfulness" and to make something "known and transparent". The Swiss agency for the authorization and supervision of therapeutic products, Swissmedic, ensures that only high-quality, safe and effective therapeutic products can be put on the market in Switzerland. If there is an incident with a medical product, a report must be made to Swissmedic.
The obligation to report serious adverse effects (incidents) with medical products has already existed in Switzerland since 1996. Until 2002, however, this was only mandatory for the manufacturers and suppliers of medical products. In 2002, legislation (the Therapeutic Products Act) extended this obligation to professional users. Every hospital must appoint a designated Vigilance Contact Person (VCP) who is responsible for reports to Swissmedic and must implement an internal reporting system (Materiovigilance System).
Medical devices are becoming more complex and, due to their application in diagnostics, treatment and patient monitoring, influence the quality of patient care considerably. The success of medical and healthcare-related services depends directly on the correct and safe use of medical devices. It is therefore imperative that all users applying devices on patients are instructed or trained in the correct operation of the respective type of device. The device certificate was introduced on a group-wide basis.