The EU Directive for the registration of medical devices defines a medical device as:
Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap,
- Investigation, replacement or modification of the anatomy or of a physiological process, or
- Control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.