The classification of healthcare products in the European Union affects compliance, market access, and regulatory obligations. One of the common challenges involves distinguishing between the classification of certain medical devices and medicines. A recent judgment by the Court of Justice of the European Union (CJEU) in Case C‑589/23 further clarifies the distinction between medical devices and medicinal products.
How medicines and medical devices are regulated in the EU?
In the EU, medical devices are regulated by Regulation (EU) 2017/745 (MDR), while medicinal products are mainly regulated by Directive 2001/83/EC. Generally, one of the main criteria to take into consideration when classifying medicines and medical devices is how the product achieves its intended use. For instance, when a product achieves its intended use through “pharmacological, immunological, or metabolic action”, it can qualify as a medicinal product.
CJEU’s key findings: clarification on pharmacological action
The case concerned the interpretation of Article 1(2)(b) of Directive 2001/83/EC:
Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
The case involved a product intended to prevent bacterial adhesion in urinary tract infections, marketed as a medical device. The Court assessed whether the product’s mechanism of action met the criteria of “pharmacological action” as defined in the mentioned Article, and should therefore be classified as a medicinal product. Considering the objectives of the EU legislation (including broadly interpreted concept of ‘’medicinal product’’), past case-law, and existing Meddev and MDCG Guidance, the main findings include:
- Interpretation of pharmacological action: The Court analysed the product’s interaction with the body based on the existing definitions that provide relatively open concepts of an ‘’interaction, typically at a molecular level, between a substance or its metabolites and a constituent of the human body which results in initiation, enhancement, reduction or blockade of physiological functions or pathological processes’’ In this line, the Court added that such an interaction does not need to result in a priori in a modification of the molecular structure of the cellular constituent. Moreover, the binding between the molecules of the substance and the cellular constituent does not need to be of permanent nature, Consequently, the judges concluded that a substance binding reversibly to bacteria to prevent adhesion constitutes a pharmacological action. Consequently, the product falls under the scope of Directive 2001/83/EC.
Impact on medical device classification: The Court reaffirmed that in case of doubt whether a product is a medicinal product, the Directive on medicinal products prevails over other EU product safety legislation and cannot be classified as a medical device.
Implications for manufacturers
Manufacturers must carefully evaluate their products’ mode of action before determining classification. Errors in classification can lead to regulatory issues, market restrictions, and legal consequences.
We recommend manufacturers to:
- Assess their product’s mode of action as per EU product safety legislation.
- Seek guidance for borderline cases.
- Consider examples in MDCG guidance and case law in classification decisions
The CJEU’s ruling in Case C‑589/23 reinforces the importance of precise classification. Manufacturers must take a proactive approach to ensure compliance to avoid regulatory challenges.
Do you have questions on the classification of your device? Contact us here or at mdlaw@obelis.net.
References
Court of Justice of the European Union, Judgment of 13 March 2025, Case C‑589/23, Cassella-med GmbH & Co. KG and MCM Klosterfrau Vertriebsgesellschaft mbH v Verband Sozialer Wettbewerb eV, ECLI:EU:C:2025:XXX.
MDlaw (2023), “Which Guides to Consider When Classifying Devices? Retrieved on 19/03/2025
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