Court of Justice, Seventh Chamber

19 January 2023, Joined Cases C‑495/21 and C‑496/21

(C‑495/21 L. GmbH v Bundesrepublik Deutschland)

(C‑496/21 H. Ltd v Bundesrepublik Deutschland)

Reference for a preliminary ruling – Medical devices – Directive 93/42/EEC – Article 1(2)(a) – Definition – Article 1(5)(c) – Scope – Medicinal products for human use – Directive 2001/83/EC – Article 1(2) – Definition of the concept of ‘medicinal product’ – Article 2(2) – Applicable legal framework – Classification as a ‘medical device’ or as a ‘medicinal product’

1. Article 2(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004,

must be interpreted as meaning that it applies not only to ‘medicinal products by function’, as referred to in Article 1(2)(b) of Directive 2001/83, as amended, but also to ‘medicinal products by presentation’, as referred to in Article 1(2)(a) of that directive.

2. Article 1(2)(a) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, and Article 1(2) of Directive 2001/83, as amended by Directive 2004/27,

must be interpreted as meaning that where the principal mode of action of a product is not scientifically established, that product cannot meet the definition of the concept of ‘medical device’, within the meaning of Directive 93/42, as amended by Directive 2007/47, or that of ‘medicinal product by function’, as referred to in Directive 2001/83, as amended by Directive 2004/27. It is for the national courts to assess, on a case-by-case basis, whether the conditions relating to the definition of the concept of ‘medicinal product by presentation’, as referred to in Directive 2001/83, as amended by Directive 2004/27, are satisfied.

categoria:European Case Law