Judgment_paragraph 44 · Laboratoires Lyocentre v Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto (C-109/12)

44As regards more particularly the distinction between medicinal products and medical devices, Article 1(5)(c) of Directive 93/42 specifically requires the competent authorities to take particular account of the principal mode of action of the product. It thus follows from Article 1(2)(a) of that directive that only a product which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means may be classified as a medical device.