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SubscribeThe July 2, 2026, judgment of the Court of Justice of the European Union (CJEU) in Case C-427/24, Diagramm Halbach, clarifies the criteria for determining whether a product constitutes a "medical device" under Article 2(1) and (12) of Regulation (EU) 2017/745 ("MDR"). The ruling analyzes the role of the "intended purpose" and the requirement that the product objectively performs one of the specific medical functions set forth in the Regulation.
Background and subject matter of the dispute
The case originated in Germany, where patient identification wristbands for hospital use were marketed. The wristbands were supplied blank and could be printed with letters, numbers, or barcodes to identify patients. The manufacturer’s promotional material indicated that identification using these wristbands could improve patient safety, particularly in the administration of medications, the performance of tests and procedures, blood transfusions, and the collection of samples.
A German association combating unfair competition argued that the wristbands were medical devices due to the intended purpose stated by the manufacturer in its advertising[1]. Therefore, the wristbands should bear the CE marking and a declaration of conformity. The manufacturer contended that, since the wristbands were supplied blank, they served a purely administrative identification function.
The German court asked the CJEU whether the wristbands should be classified as medical devices and what role the “intended purpose” plays in that analysis.
Intended purpose: manufacturer’s statements and objective functionality
Article 2(12) of the MDR defines "intended purpose" as the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation. The CJEU acknowledges that promotional material can help determine the intended purpose. However, not every statement in such material is decisive: the key question is whether the data actually relate to the use of the product or merely provide contextual information to promote its adoption.
Furthermore, the CJEU confirms that the manufacturer’s presentation of the product is not conclusive on its own: the product must also objectively perform one of the functions for the specific medical purposes listed in Article 2(1) of the MDR. In the case at hand, the wristbands did not fulfill this function, as they were limited to identifying the patient without having any direct influence on diagnostic or therapeutic activities[2] .
The CJEU also distinguishes the present case from the doctrine established in the judgment of December 7, 2017, Snitem and Philips France (C-329/16, EU:C:2017:947). In that case, the product at issue was software that used patient-specific data to detect contraindications, drug interactions, or excessive dosages, providing useful information to the physician to assist in his or her practice. Therefore, the software did not merely perform administrative functions but processed data and generated relevant medical information.
The Diagramm Halbach judgment confirms that the mere use of a product in a healthcare context is not sufficient to classify it as a medical device when it does not objectively perform a medical function.
Conclusion
The ruling establishes a two-part test for classifying a product as a “medical device”: (i) the intended purpose indicated by the manufacturer, based on data regarding the product’s actual use, and (ii) verification that the product objectively performs functions for any of the specific medical purposes listed in Article 2(1) of the MDR. The ruling also provides useful guidance for borderline products, including certain types of software, confirming that mere use in a healthcare context is not sufficient when the product does not objectively perform a medical function.
For more information, please contact our specialists through the Knowledge and Innovation Area.
[1] According to Article 2(1) of the MDR: “medical device” means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease (…).
[2] Paragraph 38 of the Judgment: “it must be observed that that objective could also be achieved, for example,through the wearing of a nameplate, a personalised badge, a copy of an identity document or anyother means of identification, which demonstrates that an identification wristband, as such, has nodirect influence on diagnostic or therapeutic activities.”
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