CJEU Ruling Clarifies Scope Of Medical Device Definition

The CJEU has delivered a preliminary ruling in Case C-427/24 Diagramm Halbach, which provides guidance on determining whether a product is a medical device within the meaning of Regulation (EU) 2017/745 (“MDR”). The judgment confirms that the manufacturer’s advertising of a product is not necessarily decisive in determining whether it has a “medical purpose” within the definition of “medical device” under the MDR, and that the product must also objectively perform one (or more) of those medical purposes to fall within that definition. The judgment also provides guidance on what constitutes a solely administrative function that does not fall within those medical purposes. The decision has the potential to guide other classification decisions of borderline products used in the healthcare sector.

Background

The referral arose from a German case concerning patient identification wristbands used in healthcare settings. The wristbands were supplied blank, and could be printed individually with letters, digits and/or a barcode to identify patients.

The producer’s promotional materials stated that identifying patients using the wristbands could improve patient safety, particularly in the areas of medication, performance of tests and procedures, blood transfusions and sample collection. The company supplying those wristbands in Germany did not verify whether the wristbands were CE marked or whether an EU declaration of conformity had been drawn up. A trade association brought a claim against the distributor seeking,amongst other things, a prohibitory injunction to prevent the sale of the wristbands in Germany, as they qualify as “medical devices” within the meaning of Article 2(1) of the MDR due to the way they are advertised. As the products are not CE marked under the MDR, it would be unlawful to make available the products if they do qualify as medical devices.

The German Court referred to the CJEU the question of whether the wristbands were classified as medical devices within the meaning of Article 2(1) of the MDR, which includes products used for specific medical purposes, including diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.

The Court also asked whether the promotional material indicated the “intended purpose” of the wristbands within the meaning of Article 2(12) of the MDR i.e., 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 held that the wristbands do not qualify as a medical device under the MDR. In its reasoning, it laid down several principles to guide the determination in device qualification borderline cases, which we discuss below.

Intended purpose

The CJEU emphasised that the intended purpose is an “important element” of the concept of a medical device under the MDR. However, the ruling notes that the MDR does not define a medical device solely based on how it is “presented” by its manufacturer, but the product must also “objectively perform” one of the medical purposes within the definition of “medical device” in the MDR.

The trade association argued that the wristbands were, based on the advertising, intended to prevent patient-identification errors in medication, tests and procedures (including operations), blood transfusions and sample collection, and ultimately to prevent deaths caused by medical errors.

The CJEU disagreed, and concluded that the intended purpose was simply the correct identification of patients, which was not a medical purpose within the meaning of Article 2(1) of the MDR.

The CJEU held that the contextual information in the advertisement was not decisive in this case. That information in the advertisement was not necessarily presenting the product as a medical device, but was arguably promoting the putting in place of appropriate patient identification systems.

Administrative function

A key aspect of the CJEU’s reasoning was that the wristband performed a purely administrative function, facilitating the correct identification of the patient. The CJEU noted that this function could have been achieved through other simple means, such as a nameplate, personalised badge, or an identity document. Therefore, the method of identifying the patient had no direct influence on diagnostic or therapeutic activities.

The CJEU also dismissed the trade association’s arguments based on the earlier decision in Snitem and Philips France (C‑329/16), where software capable of analysing patient-specific information for clinical purposes was found to constitute a medical device. The CJEU distinguished that case, explaining that the software held to be a medical device in that case did not perform a solely administrative function, given that it processed the data which had been fed into it, and provided information to doctors with a view to assisting them in their work.

The CJEU explained that the concept of a medical device cannot be regarded as including software that, while intended for use in a medical context, has the sole purpose of archiving, collecting and transmitting data (as it held in Snitem and as has long been stated in EU-level guidance in the form of current MDCG Guidance and the previous MEDDEV guidance). In extending this reasoning to the current case, these would be solely administrative functions analogous to the patient identification wristbands.

Looking ahead

The guidance from the CJEU in this ruling has the potential to be applied to other determinations of borderline devices. The decision may be of particular interest for software developers that do not wish to be subject to the medical device regime. The judgment is clear that not all software tools would be classed as medical devices, even when used in a medical context, so long as they have a purely administrative function.

The judgment also suggests that making references to the advantages of use in a healthcare setting will not automatically qualify a product as a medical device where that product does not itself perform a medical purpose under the MDR. However, in borderline situations where it is more arguable that the device is performing a medical purpose, suppliers should still be cautious in making any claims that may link the product with a medical purpose.