Biochemical processes

The term helps decide whether a product acts by metabolic means, which would usually make it a medicinal product rather than a device. MDCG 2022-5 notes that no known receptor is needed for an action to count as metabolic.

The term ‘biochemical processes’ is understood as reactions available for the human body including anabolic and catabolic reactions and transport of substances between compartments. An interaction with a known receptor is not a prerequisite for the metabolic means of action.

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