In its judgment of 2 July 2026 in Case C-427/24, the Court of Justice of the European Union ruled that, in light of the definition of ‘medical device’ set out in Article 2(1) and (12) of Regulation (EU) 2017/745, patient identification wristbands supplied without any markings and intended to be worn by patients in the healthcare sector cannot be classified as such, even though they may be individually printed with letters, numbers and/or a barcode for the purpose of recording identification details and other relevant data.

Specifically, the question referred for a preliminary ruling to the Court arose from the fact that, in an advertising document provided by the manufacturer of the products, it was stated that the identification of patients by means of such wristbands could improve their safety, in particular in the context of the administration of medicines, the performance of tests and blood transfusions, by preventing dangerous errors on the part of healthcare staff.

According to the European judges, although advertising may help to clarify the ‘intended purpose’ of the products, as defined in Article 2(12), when classifying a product as a ‘medical device’, account must be taken not only of the information provided by the manufacturer but also of whether the product objectively fulfils the functions set out in Article 2(1) of Regulation 2017/745, and the information itself must also be interpreted from the perspective of the intended user.

In the present case, the wristbands were supplied unmarked and described solely in relation to their use, namely the identification of patients, an objective which  could also be achieved by other means (via a name tag, a personalised badge or a copy of an identity document), which demonstrates that an identification bracelet, as such, has no direct influence on diagnostic or therapeutic activities, nor does it have any other specific medical purpose amongst those mentioned in the regulation.