In brief
On 19 January, the Court of Justice of the European Union (CJEU) specified that Art. 2(2) of Directive 2001/83/EC, pursuant to which, in case of doubt on the classification of a product as a medicine or a medical device, the provisions on medicinal products shall apply, covers both “medicinal products by function” (i.e., substances exerting pharmacological, immunological or metabolic action) and “medicinal products by presentation” (i.e., substances presented as having properties for treating or preventing disease).
Key takeaways
Moreover, with reference to the distinction between a medicinal product and a medical device, the CJEU clarified that where the principal mode of action of a product is not scientifically established, that product cannot meet the definition of medical device nor of medicinal product by function and that, in such a case, it is for the national courts to assess, on a case-by-case basis, whether the conditions relating to the definition of “medicinal product by presentation” are satisfied.
