LIFE SCIENCES | The ECJ on Medical Devices and Medicinal Products legal classification

On 13 March 2025, the European Court of Justice (ECJ), in its judgement in Case C-589/23, (Cassella-med GmbH & Co. KG and MCM Klosterfrau Vertriebsgesellschaft mbH v Verband Sozialer Wettbewerb eV), established a key interpretative principle concerning the legal classification of medicinal products under Directive (CE) No. 83 of 6 November 2001. The dispute concerned the regulatory classification of products (Femannose and Femannose N) containing D-mannose, which were marketed as medical devices. However, the claimant argued that, since the active substance exerts a pharmacological action, such products should be classified as medicinal products by function pursuant to Article 1(2)(b) of Directive 2001/83/CE. Upon assessing the mechanism of action of the substances in question, the Court confirmed the existence of a pharmacological effect, thereby establishing the applicability of the regulatory framework for medicinal products. Regulation (UE) No. 745 of 5 April 2017 (MDR) also reinforces the criterion of the principal mode of action as the decisive factor for distinguishing between the legal regimes of medical devices and medicinal products. Further supporting this interpretation, Article 2(2) of Directive 2001/83/CE provides that, in cases of doubt, the medicinal products legislation shall prevail over other EU regulatory frameworks. This approach aligns with well-established case law and aims to ensure a higher level of public health protection. The judgment has a significant impact, particularly on D-mannose-based products (and similar substances), which may require marketing authorization (MA) if they are classified as medicinal products by function. More broadly, it calls on economic operators to carefully assess the principal mode of action of their products to ensure correct regulatory classification.

Newsletter n. 108 – June 2025