Patient Wristbands as Medical Devices or Mere Identification Tools? The CJEU on Intended Purpose under the MDR

Patient wristbands are part of the standard inventory of inpatient care. By being individually printed with names, dates of birth or barcodes, they are intended to ensure that patients are correctly matched to their treatment. Quite frequently, patient wristbands are marketed with the claim that identifying patients with the help of these wristbands improves patient safety. Whether such a product, on that basis, classifies as a medical device within the meaning of Regulation (EU) 2017/745 on medical devices (“MDR”) had until now remained unresolved. In its judgment of 2 July 2026 in Case C-427/24 – Zentrale v Diagramm Halbach, the Court of Justice of the European Union (“CJEU”) answered this question in the negative and made fundamental findings on the concept of intended purpose under Article 2(12) MDR.

In the underlying proceedings, Diagramm Halbach marketed patient wristbands made of thermoplastic resin that had been manufactured by Zebra Technologies. The patient wristbands were supplied blank and could be individually printed with patient data (name, date of birth, barcode). The wristbands did not bear a CE marking under the MDR. Zebra’s promotional materials, however, emphasised that the wristbands enabled staff to check the “five rights” at the patient’s bedside (the right patient, the right medication, the right dose, the right time and the right route of administration) and that using the wristbands could improve patient safety, in particular in connection with the administration of medication, tests and procedures, blood transfusions and sample collection. The material also contained data on the statistical frequency of identification errors and their consequences.

Zentrale, the German trade association for combating unfair competition, brought claims for injunctive relief, arguing that the wristbands – at least in combination with other products – served the monitoring, diagnosis and treatment of diseases and injuries and therefore fell within the scope of the MDR. Following a reference for a preliminary ruling from the Regional Court Bochum, the CJEU has now held that the patient wristbands at issue cannot be classified as a medical device.

I. Only Use-Related Manufacturer Information Is Relevant

The CJEU first clarifies that, while the relevant intended purpose under Article 2(12) MDR must be determined by reference to the data supplied by the manufacturer on the label, in the instructions for use, in promotional and sales material and in the clinical evaluation, not all of that data is necessarily material to that determination. According to the wording of the provision, only data that actually relates to the use of the product concerned is decisive. Contextual information that is merely useful and is intended to promote the sale of particular products, such as general statistics on treatment errors or generic references to benefits for patient safety, is therefore not material to determining the intended purpose. With regard to the patient wristbands, the CJEU explains that promotional material describing the wristbands solely in terms of their use for patient identification does not, in itself, provide any indication of a medical use.

II. Objective Limitation of the Intended Purpose

The CJEU further emphasises that the MDR does not define a medical device solely on the basis of how it is presented by its manufacturer. Unlike medicinal products under Article 1(2)(a) of Directive 2001/83/EC, the classification of a product as a medical device must also take into account whether that product is objectively capable of performing the specific medical functions listed in Article 2(1) MDR. The CJEU also justifies this approach on teleological grounds: some manufacturers might affix a CE marking under medical device law purely for marketing reasons. The objective functional test therefore acts as a corrective in both directions. It prevents manufacturers from circumventing the MDR by deliberately omitting any reference to a medical purpose, while also preventing excessive regulation of products whose actual function is not medical in nature. With regard to the patient wristbands at issue, the CJEU finds that they are objectively not capable, by themselves, of providing a medical service, even though they are used in a medical context. The patient wristbands were supplied unprinted and served a purely administrative purpose. The identification objective could equally be achieved by wearing a nameplate or another means of identification. This shows that the method of identification, as such, has no direct effect on the administration of medication, tests and procedures, blood transfusions or sample collection. All of the medical benefits depend on other factors – not on whether the patient is wearing a wristband.

III. Confirmation of the Snitem Case-Law

Finally, the CJEU reaffirms the distinction between administrative and medical products in its judgment in Case C‑329/16, Snitem and Philips France. The software at issue in that case did not perform solely administrative functions such as patient identification, but processed the data which had been fed into it and provided physicians with information to support their decisions. By contrast, a product that merely archives, collects and transmits data, such as pure data storage software or software indicating generic drug names, is not a medical device, even where it is used in a medical context. The distinction therefore continues to turn on whether a product merely archives, collects and transmits data or, beyond that, performs a specifically medical function.

IV. Conclusion and Outlook

The CJEU’s judgment is not surprising: it stands to reason that an unprinted wristband cannot objectively perform a medical function. Further, the classification is correct on the merits, as it consistently reflects the two-tier approach by the manufacturer’s information and objective functional capability adopted by the EU legislature. Nevertheless, the judgment is of considerable practical significance for manufacturers. First, the CJEU provides clarity that, even in a medical context, it remains permissible to promote products using contextual information, such as references to patient safety or error-rate statistics. It is also notable that the referring court found that some manufacturers of comparable patient wristbands had apparently affixed a CE marking under medical device law solely for marketing purposes, without the underlying products actually serving a medical purpose. Such conduct is not without legal risk. A manufacturer that adorns a product with a CE marking under medical device law without being able to demonstrate an actual clinical benefit and the required performance runs the risk of engaging in misleading conduct relevant under competition law and regulatory supervision. The same applies where a product has been certified as a Class IIa or IIb device by a Notified Body.

Second, by confirming the Snitem case-law, the judgment also opens up a welcomed perspective for the AI industry. For so-called medical scribes and other documentation tools that merely archive, collect and transmit data (for example, by transcribing doctor-patient conversations or automating medical documentation), the judgment confirms that such tools do not fall within the scope of the MDR, provided that they do not offer clinical decision support. However, as soon as software processes patient-related data and derives recommendations or guidance for the treating physician from it, it crosses the threshold into becoming a medical device.

This article was prepared in collaboration with our research assistants Carla Alpüstün and Sophia Heun.