The Regulation 2017/745 lays down rules concerning the placing on the market of Medical Devices, aiming at ensuring the safety and protection of the health of patients, users and other persons when using such products.
Medical Devices are a wide range of products (instruments, apparatus, implants, substances, software or other) intended to be used in or on human beings for diagnosis, prevention, monitoring or treatment, alleviation of or compensation for injuries or disabilities, but also for investigation, replacement or modification of the anatomy or of a physiological process or for the control of conception. The Medical Device does not achieve its principal intended action by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means (ancillary action).
The intended use of the product shall be characterized as a medical purpose.