The Summary of Safety Characteristics and Clinical Performance (RCSPC) is a new European requirement for implantable and most risky medical devices.
The RCSPC is a document approved as part of the marketing authorization for each medical device. We make it available to patients or future patients, but it can also be downloaded via the Eudamed database (as soon as it is available). This summary is a complete overview of the device and its intended use. It also lists the associated risks and the precautions for use. The Summary of Safety Characteristics and Clinical Performance presents the available clinical data and also those being acquired as well as possible medical alternatives. This summary has been written in the most popularized way possible to ensure maximum understanding by all patients or future patients. However, if questions persist, we invite you to consult your surgeon.