Pharmacological means

If a product's principal intended action works by pharmacological means, it is a medicine in the EU, not a device. MDCG 2022-5 helps manufacturers of substance-based devices show that their principal action is physical or another non-pharmacological mechanism.

‘Pharmacological means’ is understood as an interaction typically at a molecular level between a substance or its metabolites and a constituent of the human body which results in initiation, enhancement, reduction or blockade of physiological functions or pathological processes. Examples of constituents of the human body may include, among others: cells and their constituents (cell membranes, intracellular structures, RNA, DNA, proteins, e.g. membrane proteins, enzymes), components of extracellular matrix, components of blood and components of body fluids.

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