A crucial EU ruling (Case C-589/23) redefines the distinction between medical devices and medicinal products, clarifying when a substance—like D-mannose—exerts a pharmacological action under Directive 2001/83/EC
The boundary between “medicinal product” and “medical device” is often subject to divergent interpretations in European markets, especially for so-called borderline products that do not clearly fall under one or the other definition. The recent CJEU judgment C-589/23 provides a key clarification on the concept of “pharmacological action” within the meaning of Directive 2001/83/EC.
The case concerned the marketing and promotional advertising of two D-mannose-based products, proposed as medical devices for the prevention and treatment of cystitis and other urinary tract infections. The products differed in that one included a secondary plant extract (cranberry extract), which was later removed in the newer version.
These products became the subject of a lawsuit filed with the Regional Court of Cologne by a German association active in defending competition in the healthcare sector, which challenged their classification as medical devices. According to the association, the products should have been considered medicinal products by function, and therefore subject to the requirement for marketing authorization.
The court upheld the claim, and the decision was confirmed on appeal, with a ruling recognizing that the mechanism of action of D-mannose constituted a pharmacological action under European medicinal product law.
The key question: what is a “pharmacological action”?
According to Article 1, point 2, letter b) of Directive 2001/83, a “medicinal product by function” is any substance that restores, corrects, or modifies physiological functions by exerting a pharmacological, immunological, or metabolic action.
In the case at hand, the D-mannose molecule binds reversibly to bacteria (particularly Escherichia coli), preventing them from adhering to the bladder wall. The question raised was whether this mechanism could be considered pharmacological, even in the absence of direct metabolic or immunological action.
Medical device vs. medicinal product: what’s the difference?
Medical device: a product (instrument, substance, software, implant, etc.) intended to be used for diagnostic or therapeutic purposes, but whose principal action on the human body is not achieved by pharmacological, immunological, or metabolic means. The therapeutic effect is generally mechanical, physical, or barrier-based (e.g., patches, lenses, barrier substances).
Medicinal product (drug): a substance or combination of substances that exerts its primary effect through pharmacological, immunological, or metabolic mechanisms to restore, correct, or modify physiological functions or to make a diagnosis. Requires marketing authorization and clinical studies to support efficacy and safety.
The Court’s interpretation: reversible binding is still pharmacological
With a binding decision, the CJEU ruled that:
“A substance that binds reversibly to bacteria and prevents them from attaching to human cells exerts a pharmacological action.”
The Court justified this position with:
- An extensive interpretation of the definition of “medicinal product,” in line with public health protection (Art. 168 TFEU);
- Reference to EU guidance documents (Meddev and MDCG 2022-5), which recognize pharmacological action even in cases of reversible interactions and without structural modifications to cells;
- The need to classify such products under the stricter regulatory framework, that of medicinal products, in case of doubt (Art. 2(2) of Directive 2001/83).
Regulatory and commercial implications
➤ A new interpretative threshold for borderline devices
The ruling substantially redefines the criteria for determining whether a product primarily acts through pharmacological means. A functional molecular interaction, even reversible, as in the case of D-mannose, is enough to fall under medicinal product regulation.
➤ Risk of reclassification for many products on the market
Many medical devices currently marketed could, under this interpretation, be subject to re-evaluation. Particularly:
- products for urinary tract infections,
- substances acting on viruses, bacteria, or parasites via molecular binding.
➤ Marketing authorization required if considered medicinal
If a product is classified as a medicinal product by function, it cannot be marketed without marketing authorization (MA), making a CE mark as a medical device insufficient.
A clear but stricter approach
The Court reiterated that in case of doubt, the medicinal product legislation takes precedence over that of medical devices. This principle confirms a judicial trend of strengthening pre-market surveillance on borderline products, prioritizing the precautionary principle.
With the Court’s interpretation, pharmacological action is extended to mechanisms previously considered mechanical or physical. This requires companies to review their classification strategies, technical dossiers, and regulatory approaches.
As manufacturers of food supplements, medical devices and cosmetics, we provide our in-house regulatory and scientific expertise to help navigate an ever-evolving market. We are the ideal partner for companies seeking to grow while confidently addressing regulatory changes.
