LIFE SCIENCES | The CJEU on the meaning of “Medical Device”and “Intended Purpose” under Regulation (EU) 2017/745

On 2 July 2026, the EU Court of Justice issued its judgment in Case C-427/24 (Zentrale zur Bekämpfung unlauteren Wettbewerbs Frankfurt am Main eV v Diagramm Halbach GmbH & Co. KG) ruling that patient identification wristbands (made from thermoplastic resin and intended to be worn in the healthcare sector) supplied without any printing and capable of being personalized subsequently with patients’ data, cannot be classified as “medical devices” within the meaning of Article 2, points 1 and 12 of Regulation (EU) No. 745 of 5 April 2017 on medical devices (the MDR).

To this end, the Court examined the concept of “intended purpose”, as this is one of the relevant factors for determining whether a product constitutes a medical device. In particular, the Court clarified that the intended purpose is determined on the basis of the indications for use provided by the manufacturer, which appear in one of the media exhaustively listed in Article 2.12 of the MDR, including promotional or sales materials and statements. However, the Court specified that not all information contained in advertising or sales materials is relevant for determining the intended purpose; rather, only indications concerning the use of the product are relevant. Consequently, contextual information contained in advertising and aimed at promoting the sale of products is not decisive for determining the intended purpose of those products (par. 29 of the judgement).

Furthermore, the Court stated that it is necessary to verify whether the product objectively performs one of the specific medical functions listed under Article 2.1 of the MDR (par. 28). Accordingly, the classification of a product as a medical device cannot be based solely on the manufacturer’s presentation of its product, unlike what may be the case for medicinal products (within the meaning of Article 1(2)(a) of Directive (EC) No. 83 of 6 November 2001) (par. 22). Therefore, marketing claims cannot, by themselves, determine the intended purpose of a product (par. 28).

In this case, the Court established that the wristbands performed a merely administrative function, namely facilitating the identification of patients, and that they could not perform any of the specific medical functions referred to in Article 2.1 MDR (e.g., diagnostic or therapeutic functions).

Newsletter n. 121 – August/September 2026