The legal dispute underlying the judgment of the Federal Administrative Court (BVerwG) of 30 July 2025 (Case No.: 3 C 6.24) concerns the distinction between substance-based medical devices and medicinal products. The claimant is a manufacturer of nasal drops, which it markets as a medical device.
The defendant, the Federal Institute for Drugs and Medical Devices (BfArM), considers the claimant’s nasal drops to be a medicinal product subject to marketing authorization under Section 21 of the German Medicinal Products Act (AMG). In its view, the product meets the requirements of a functional medicinal product pursuant to Section 2(1) No. 2(a) AMG, since the intended primary effect of the preparation is achieved by pharmacological means. At the very least, the product qualifies as a medicinal product by presentation within the meaning of Section 2(1) No. 1 AMG. The claimant’s objection against this classification was rejected by the defendant.
Previous Course of Proceedings
The claimant’s action and subsequent appeal were also unsuccessful. In its judgment of 26 September 2019, the Higher Administrative Court (OVG) of Münster held that, based on the information in the instructions for use and on the packaging of the nasal drops, the requirements of a medicinal product by presentation under Section 2(1) No. 1 AMG were fulfilled. The concept of a medicinal product by presentation also applies where a product is marketed as a substance-based medical device. At the same time, a non-pharmacological mode of action had not been established at the time of the oral hearing according to the state of scientific knowledge: the product’s mechanism of action ultimately remained unclear, so that its classification as a medicinal product under Section 2(1) No. 1 AMG persisted.
The claimant has lodged an appeal on points of law against this judgment. It takes the view that the concept of a medicinal product by presentation is not applicable to substance-based medical devices. The contrary view adopted by the appellate court would result in the primacy of pharmaceutical law, which does not correspond to the statutory system and would impose on the manufacturer the burden of proof for a non-pharmacological mode of action.
Decision of the Federal Administrative Court
BVerwG dismissed the claimant’s appeal on points of law as unfounded. In doing so, the Court confirmed the classification of the nasal drops as a medicinal product subject to marketing authorization. In its reasoning, BVerwG relied in particular on the judgment of the Court of Justice of the European Union (CJEU) of 19 January 2023 (Cases C-495/21 and C-496/21), which had been delivered in preliminary ruling proceedings concerning a similar product from the same manufacturer.
Following the CJEU’s decision, BVerwG held that a product marketed as a medical device may simultaneously qualify as a medicinal product by presentation within the meaning of Section 2(1) No. 1 AMG. The claimant’s argument that this approach improperly imposes on it the burden of proof for the classification as a medical device was rejected. CJEU had clarified that a manufacturer intending to market a product as a medical device must demonstrate that the requirements for such classification are met.
The decisive factor for classification as a medicinal product by presentation is whether the product is either expressly described as a means for treating or preventing disease, or whether, from the perspective of an average, reasonably well-informed, observant, and circumspect consumer, its presentation creates the impression that it has curative, preventive, or symptom-relieving effects. This assessment requires an overall evaluation of the product. Relevant considerations include, in particular, the product’s presentation, references to interactions with medicinal products, information on adverse effects, and whether the product is sold exclusively in pharmacies.
In the present case, the packaging referred to the indication “for the supportive treatment of a common cold,” the product was distributed exclusively through pharmacies, and the instructions for use contained information on interactions. According to BVerwG, these elements created the impression, from the consumer’s perspective, that the product was a medicinal product. The fact that the packaging bore the abbreviation “MP” did not alter this assessment, as this designation is not commonly understood by consumers. Nor did the explicit statements on the packaging and in the instructions for use indicating that the product was a (pharmacy-only) medical device suffice, since the mode of action constitutes the decisive criterion for distinguishing between medical devices and medicinal products.
The fact that, according to the findings of the lower court, the mechanism of action of the nasal drops remained scientifically unclear did not lead to a different conclusion. Rather, the OVG had correctly assumed that there was no scientific evidence supporting the physical mode of action asserted by the manufacturer, while a pharmacological principal effect could not be ruled out. In this respect, BVerwG confirmed that where a non-pharmacological principal mode of action cannot be established due to a lack of evidence, classification as a medical device is excluded – the burden of proof in this regard lies with the manufacturer. In such cases, pharmaceutical law takes precedence over medical device law. The courts are not required to obtain further expert opinions where the mode of action remains uncertain.
Implications for Practice
The decision of BVerwG significantly tightens the regulatory requirements for manufacturers of substance-based medical devices. Given the allocation of the burden of proof to the detriment of manufacturers, they are required to substantiate and demonstrate that the relevant criteria are met if they seek classification as a medical device. In practical terms, this means that manufacturers must provide robust scientific evidence of a non-pharmacological – i.e., physical – principal mode of action already at the development and approval stage. If they fail to do so, the product risks being classified as a medicinal product regardless of its intended designation as a medical device, thereby becoming subject to the correspondingly stringent marketing authorization requirements.
