Principal intended action

In EU borderline decisions, the principal intended action is identified first, and its principal mode of action then decides whether the product is a device or a medicine. Claims in labeling and promotion therefore carry real regulatory weight.

The principal intended action of a medical device is described in manufacturer's labelling and claims and must be based on state of the art scientific data regarding the principal mode of action, on a case-by-case basis.

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