A medical device is an instrument, apparatus, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body and which does not achieve any of its primary intended purposes through chemical action within or on the body. Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, thermal, physico-chemical or chemical means.

Medizinprodukt bezeichnet einen Gegenstand, der zu medizinischen Zwecken für Menschen verwendet wird, wobei die Wirkung im Unterschied zu Arzneimitteln primär physikalisch erfolgt.