Principal mode of action

Under EU rules, a product that achieves its principal intended action by pharmacological, immunological or metabolic means is a medicine, while physical or other means point to a device. MDCG 2022-5 says this must be judged on objective scientific data.

The principal mode of action represents the means by which the product achieves its principal intended action, i.e. pharmacological, immunological, metabolic, physical or other. It is objective and must be based on state of the art scientific data.

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