CJEU Decision on Classification as a ‘Medical Device’ or a ‘Medicinal Product’

The Court of Justice of the European Union (CJEU) delivered its judgment in March 2025 on Case C-589/23. The case considered the interpretation of what constitutes a ‘pharmacological action’ within the meaning of Article 1(2)(b) of Directive 2001/83.

The decision provides useful insights on the CJEU’s approach to the sometimes unclear boundary between ‘medical devices’ and ‘medicinal products’ in the EU.

Background

Femannose and Femannose-N were products containing D-mannose and cranberry extract. These products were marketed by the company Cassella-med GmbH & Co. KG (Cassella-med) as medical devices. The products were also advertised as medical devices on a website operated by MCM Klosterfrau Vertriebsgesellschaft mbH (MCM Klosterfrau).

Verband Sozialer Wettbewerb eV (VSW), a trade association, brought an action before the Landgericht Köln (Regional Court, Cologne, Germany) seeking an injunction against the marketing and advertising of Femannose as a medical device. This was on the basis that the products were actually medicinal products and by extension, had been placed on the market in the absence of the necessary marketing authorisations.

The injunction was granted and an appeal brought by Cassella-med and MCM Klosterfrau was dismissed by the Oberlandesgericht Köln (Higher Regional Court, Cologne, Germany).

Cassella-med and MCM Klosterfrau brought a further appeal on a point of law to the Bundesgerichtshof (Federal Court of Justice, Germany), which then referred the following question to the CJEU:

‘Is there a pharmacological action within the meaning of the first case in Article 1(2)(b) of Directive 2001/83 where the substance in question (in this case: D-mannose), by means of a reversible binding to bacteria via hydrogen bonds, prevents the bacteria from adhering to human cells (in this case: the bladder wall)?’

Decision

In concluding that the answer was yes, the CJEU endorsed the findings of the national German courts that the products in question were more correctly classified as medicinal products under EU law.

In arriving at this conclusion, the CJEU set out a number of important observations derived from relevant legislative provisions, case law and guidance:

• An established body of EU case law was referred to e.g. C‑616/20 (M2Beauté Cosmetics), C‑495/21 and C‑496/21 (Bundesrepublik Deutschland (Nasal drops)), C‑308/11 (Chemische Fabrik Kreussler) and C‑84/06 (Antroposana and Others).
• The CJEU also analysed relevant classification guidance:
  • MEDDEV 2.1/3 Rev. 3, concerning the Medical Device Directive
  • MDCG 2022 – 5 Rev. 1, concerning the Medical Device Regulation
• The CJEU also noted various features of Directive 2001/83 such as:
  • Article 2(2) which provides that, in cases of doubt as to the correct classification of a product that may fall within the definition of a ‘medicinal product’, priority must be given to that classification.
  • Recital 7 of Directive 2004/27, which introduced Article 2(2) into Directive 2001/83, and states that, ‘in order to take account both of the emergence of new therapies and of the growing number of so-called “borderline” products between the medicinal product sector and other sectors, the definition of “medicinal product” should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products’.
  • As regards the objectives, the CJEU also noted how Directive 2001/83 is aimed at ensuring a high level of protection of human health, which is also the objective of Article 168 TFEU. From that perspective, as is apparent from recital 7 of Directive 2004/27, the scope of Directive 2001/83 must be interpreted in such a way as to ensure high standards for the quality, safety and efficacy of medicinal products for human use.

In analysing these materials, the CJEU reasoned as follows:

1. The type of interaction required to qualify as a ‘pharmacological action’ is defined relatively broadly in the Meddev Guidance and MDCG Guidance, that is to say, ‘between the molecules’ or ‘typically at a molecular level’.
2. That conclusion is reinforced by the case-law, according to which the concept of ‘medicinal product’, within the meaning of Directive 2001/83, is to be broadly construed.
3. It does not follow either from Directives 2001/83 or from the Meddev Guidance and MDCG Guidance that the molecules of the substance being classified should necessarily have to interact with a cellular constituent by means of a binding that is permanent. A substance whose binding to a cellular constituent is reversible may therefore be regarded as exerting a ‘pharmacological action’, particularly in the light of the requirement that the concept of ‘medicinal product’ be broadly construed.
4. In the circumstances, a narrow interpretation of ‘pharmacological action’ (such as an interpretation excluding interactions consisting, as in this case, in a reversible binding of a substance to bacteria by means of a hydrogen bond) would run counter to the case-law cited and jeopardise the over-arching objectives pursued by Directive 2001/83.

Impact

While providing clarity on the interpretation of ‘pharmacological action’, a concept that is to be broadly construed, this decision also highlights the importance of appropriately classifying products more generally. When considering similar issues relevant to their own products, stakeholders should carefully analyse the relevant case law and guidance. Particular consideration should be placed on how Directive 2001/83 expressly provides that in cases of doubt as to the correct classification of a product that may be a ‘medicinal product’, priority will ordinarly be given to that classification in the absence of compelling evidence that the product falls within the definition of another type of regulated product.

For more information, contact a member of our Life Sciences team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.