Medical Devices, or also referred to as sanitary products, are by definition "any instrument, device, equipment, hardware, software, material or other article, used alone or in combination, including software, by its manufacturer for diagnostic and/or therapeutic purposes and involved in its proper functioning, intended by the manufacturer to be used in human beings for diagnostic and/or therapeutic purposes:
- Diagnosis, prevention, control, treatment or alleviation of a disease.
- Diagnosis, monitoring, treatment, alleviation or compensation of an injury or impairment.
- Investigation, replacement or modification of anatomy or a physiological process.
- Birth control
And which does not exert the principal intended action within or on the surface of the human body by pharmacological, immunological or metabolic means, but to whose function such means may contribute".