In its referral decision of May 28, 2024 (Case No.: I-16 O 76/23) to the Court of Justice of the European Union (CJEU), the Regional Court of Bochum addresses the question of whether blank patient wristbands qualify as medical devices within the meaning of Article 2 para. 1 of Regulation (EU) 2017/745 (Medical Device Regulation – “MDR”). Although the court tends to reject this qualification in its decision, it has not made a final ruling on the matter but has instead referred it to the CJEU for a preliminary ruling. As a result, the CJEU will now examine this classification issue.
The referral decision of the Regional Court of Bochum is based on a competition law dispute between the German Centre for Combatting Unfair Competition and a retailer who distributes patient wristbands on the German healthcare market without CE-marking, relying on the classification of a U.S. manufacturer. The wristbands in question are entirely unprinted and can be customized with printed information to ensure the clear identification of patients in hospitals, even if they are unable to provide information themselves due to anesthesia or their personal health condition.
The manufacturer promotes its product by stating that the patient wristbands enable hospital staff to verify the "five rights" at the patient’s bedside – right patient, right medication, right dose, right time, and right administration method. This, in turn, is said to contribute to the reliable medication of patients and help prevent treatment errors, including potentially fatal ones.
Regulatory Background
The question of whether the patient wristbands in question qualify as medical devices under Article 2 para. 1 of the MDR is of particular relevance because, in this case, the product- and manufacturer-related requirements of the MDR would have to be met. Among the key requirements for the lawful distribution of medical devices is the completion of a conformity assessment procedure (Article 52 MDR) before placing the product on the market to demonstrate compliance with the essential safety and performance requirements, followed by CE-marking (Article 20 MDR) of the product. Additionally, before a distributor makes a medical device available on the market, they must also verify compliance with the product requirements in accordance with Article 14 MDR.
The qualification of a product as a medical device is determined by the legal definition in Article 2 para. 1 of the MDR. According to this definition, a "medical device" refers, among other things, to "(...) a material or another 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 (...)."
The key factor in classifying a product is primarily the so-called "intended purpose" defined by the manufacturer, as stated in Article 2 para. 12 MDR. A product qualifies as a medical device under Article 2 para. 1 MDR only if the manufacturer intends it to serve a specific medical purpose. Simply put, a product is considered a medical device only if the manufacturer attributes this characteristic to it. The mere fact that a product is used in a hospital does not automatically make it a medical device. Instead, its intended purpose must be medical, and the product must fulfill a specifically medical function. Determining the intended purpose requires a detailed analysis of the functions defined by the manufacturer, which can be found in the product labeling, the instructions for use, and accompanying promotional materials.
Court Decision
The defendant sold the wristbands without CE-marking, as they believed the wristbands did not serve a medical purpose. According to their view, the wristbands were solely for patient identification, did not perform any measurements on or within the human body, and did not otherwise affect it. Patient identification was considered an administrative process that could also be achieved with a name tag on the patient’s bed, which is unquestionably not classified as a medical device.
The plaintiff, on the other hand, argued that the wristbands qualified as medical devices under Article 2 para. 1 MDR and therefore required CE-marking. They contended that the manufacturer’s advertising included a medical intended purpose as defined in Article 2 para. 12 MDR. The wristbands were designed to improve the reliability of patient medication, medical procedures, and tests. This also included preventing mix-ups during surgeries and medical errors that could result in patient fatalities. Based on the intended purpose stated by the U.S. manufacturer, the wristbands provided an independent medical function in the form of therapeutic properties.
Furthermore, the parties dispute whether, even if the patient wristbands in question were to be classified as a medical device, the defendant would have violated its obligations as a distributor under Article 14 MDR. In this context, the defendant argues that, as a mere distributor of products from the responsible manufacturer, it should not be expected to question in detail the classification made by the manufacturer, especially due to a lack of the necessary expertise. Distributors could instead generally rely on the correctness of the manufacturer’s classification decision, unless there is a valid reason to suspect an incorrect classification.
The court tends to classify the patient wristbands in question not as medical devices under Article 2 para. 1 MDR, as they likely do not serve a diagnostic, therapeutic, or medical purpose. The purpose of the wristbands is solely patient identification, which could equally be achieved with a name tag at the patient’s bedside or their ID card. The court further noted that comparable wristbands from competitors sometimes carry the CE-marking, but sometimes do not. The distribution of the wristbands by some competitors with the corresponding CE-marking could, according to the Regional Court, have marketing reasons rather than legal obligations. To create legal certainty, the court therefore decided to refer the questions to the CJEU for a ruling.
Practical Note
The patient identification wristbands, when printed, undeniably serve to enhance patient safety in hospitals. However, it is indeed questionable whether the function of these wristbands goes beyond purely administrative purposes in the hospital and whether they have an independent medical function that would justify their classification as a medical device under Article 2 para. 1 MDR. The Regional Court of Bochum’s tendency to classify the blank wristbands as non-medical devices thus appears, at first glance, to be understandable.
The decision of the Regional Court of Bochum also clearly highlights the crucial importance of the manufacturer’s intended purpose in general, and the product advertising in particular. The case in question once again illustrates that manufacturers should carefully consider how they define the specific purpose of their product and how it is presented in their advertising. A misidentification of the product by the relevant market segments based on the manufacturer's information can have serious consequences: for the manufacturer itself, but potentially also for the importers and distributors of the product.
