Immunological means

This matters at the border between devices and medicines. If a product's principal intended action is achieved by immunological, pharmacological or metabolic means, it is a medicinal product rather than a device.

‘Immunological means’ is understood as an action initiated by a substance or its metabolites on the human body and mediated or exerted (i.e. stimulation, modulation, blocking, replacement) by cells or molecules involved in the functioning of the immune system (e.g. lymphocytes, toll-like receptors, complement factors, cytokines, antibodies).

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