According to EU Regulation 2017/745 (MDR) Chapter I, Article 2/1, a medical device is an instrument, apparatus, device, software, implant, reagent, material, or other article that, according to the manufacturer, is intended for human use and is intended, alone or in combination, to fulfil one or more of the following specific medical purposes:
Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
Diagnose, monitor, treat, mitigate, or compensate for injury or disability,
Examination, replacement, or alteration of anatomy or of a physiological or pathological process or condition,
Obtaining information through the in vitro study of from the human body.
including samples from organ, blood and tissue donations
and whose principal intended action in or on the human body is not achieved by pharmacological or immunological means or metabolically, but whose mode of action may be assisted by such means.