Action on the human body

This matters when deciding whether a product is a medical device or a medicinal product. Because the action also covers substances, organisms or pathogens in or on the body, a product that acts on bacteria on the skin can still count as acting on the human body.

The ‘action on the human body’ is to be understood to include action on any of its constituents. Such constituents include also exogenous substances, organisms or pathogens within or on the body. For the purposes of applying the MDR, the definitions for pharmacological, immunological, metabolic means of action also apply to explanted constituent parts of the body that are intended to be (re)introduced in the body or to assisted reproduction procedures.

MDCG 2022-5 Rev.1, Section 1.2.2, Definitions of pharmacological, immunological, metabolic means, Note 4