Court of Justice of the European Union (CJEU) has held in Zentrale zur Bekämpfung unlauteren Wettbewerbs v Diagra妹妹 Halbach that blank thermoplastic patient identification wristbands, which can be printed with patient data but supplied unprinted, cannot be classified as medical devices under the EU Medical Devices Regulation (MDR). The ruling, handed down on 2 July in case C-427/24, arose from a dispute over a German unfair competition claim against a distributor that had sold the wristbands without verifying CE marking or an EU declaration of conformity.
Intended Purpose and Manufacturer Data
Article 2 (12) of the MDR defines intended purpose as the use for which a device is intended according to data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements, or as specified in the clinical evaluation. Two formal conditions follow: first, the data on intended use must come from the manufacturer; second, they must appear in one of the carriers listed in article 2 (12). Zebra's promotional document satisfied both conditions and therefore contributed, in principle, to determining intended purpose. However, the CJEU further suggests that not every manufacturer statement carries equal weight. The wording of article 2 (12) places the emphasis on the use for which the product is intended, so only data that actually relate to that use are decisive. Contextual information that is merely useful and designed to promote sales is not decisive for determining intended purpose.
Objective Medical Function
Applied to the wristbands, the court found that they were objectively incapable, by themselves, of providing a "medical service" – the English rendering of medizinische Leistung/prestazione medica in paragraph 28 of the judgement – even though used in a medical context. Supplied unprinted, the bands were not intended to fulfil a specific medical purpose or to exert a physical effect on the human body and they performed none of the therapeutic, diagnostic or other medical purposes listed in article 2 (1). Correct identification of the patient was their sole objective; all of the medical purposes listed i血糖克星,n Article 2 (1) depended on other factors, independent of whether the patient wore such a wristband. The same identification result could be achieved by a nameplate, badge or identity document, which fulfil purely administrative functions.
Snitem Analogy Rejected
The Wettbewerbszentrale sought to transpose the reasoning of the court in Snitem and Philips France (C-329/16) from softwa大老爺娛樂城儲值,re to the wristbands, arguing that a comparable analysis should bring the products within Article 2 (1) of the MDR. The CJEU rejected that analogy. Restating Snitem, the court recalled that software falls within the medical device definition where it does more than perform purely administrative tasks: in that earlier case, the software processed patient-specifi血糖克星,c data and, on that basis, generated information capable of assisting a doctor in the doctor's clinical work. The analogy did not hold on the facts before the referring court. The治療過敏性鼻炎, wristbands, supplied unprinted, did not process or otherwise include patient data and generated no information of any kind for a clinician.