Medicine / medicinal product

The line between a medicinal product and a medical device is drawn mostly by the principal mode of action. If the main intended action is pharmacological, immunological or metabolic, the product is a medicine under Directive 2001/83/EC, and products that combine both need a careful borderline assessment.

Medicine / medicinal product: According to the definition given in Directive 2001/83/EC: ‘(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

MDCG 2021-24 Rev.1, Section 3.1, Basic terms and definitions (Other terms; quoting Directive 2001/83/EC)