CJEU judgment redraws the perimeter of EU medical device rules

The Court of Justice of the European Union (CJEU) has held in Zentrale zur Bekämpfung unlauteren Wettbewerbs v Diagramm 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.

The judgment's significance for medtech and healthcare businesses is not the product category itself but the court's methodology: how it frames intended purpose, filters promotional material, clarifies distributors' duties and restates the administrative versus clinical line for software first drawn in Snitem and Philips France (C-329/16).

Product design and dispute

In June 2023, Diagramm Halbach sold two types of thermoplastic patient identification wristbands manufactured by Zebra Technologies to a German nursing service. The bands could be printed individually with letters, numbers or barcodes so that a patient’s identity and related data could be recorded, but the units carried no print when supplied.

Zebra’s promotional material stated that high-quality patient identification wristbands enable staff to check the "five rights" of medication administration: right patient, right medication, right dose, right time and right route. It cited medical-error statistics and associated costs. Diagramm did not verify CE marking or an EU declaration of conformity before making the products available.

Germany's main self-regulatory association for fair competition, the Centre for Protection against Unfair Competition, known as the Wettbewerbszentrale, which is a qualified trade association under the Unfair Competition Act (UWG), treated Diagramm's position as an omission in breach of article 14 MDR and sought injunctive relief before the Regional Court of Bochum.

The national court referred two questions to the CJEU: whether the manufacturer's advertising contained an intended purpose within the meaning of article 2 (12) of the MDR; and, if so, whether the unprinted wristbands were medical devices under article 2 (1) of the MDR.

Intended purpose and manufacturer data

Under article 2 (1) of the MDR, a medical device is an instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used for one or more of the medical purposes listed in that provision. The manufacturer’s formulation of intended purpose is an element of that definition, but not the only one, the CJEU confirms. Unlike medicinal products under article 1 (2) (a) of the Medicinal Products Directive 2001/83/EC (also referred to as "medicinal products by presentation"), the MDR does not define a device solely and exclusively by how the manufacturer presents it.

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. On the facts, general statistics on treatment errors, references to the "five rights" and generic patient safety framing did not describe a medical use of the wristbands themselves; the promotional documents presented them solely in terms of patient identification. The intended purpose indicated by the manufacturer's use-related data was the correct identification of patients during their stay in care; in particular, in hospital stay.

Medical function

Whether a product qualifies as a medical device also turns on whether it objectively has the characteristics referred to in article 2 (1). Manufacturer data are interpreted from the recipient’s perspective and may inform intended purpose, though they cannot by themselves determine it. The referring court had observed that some manufacturers may have affixed a CE mark under the MDR purely for marketing reasons. The CJEU uses that observation to explain why manufacturer data, while relevant, must be read from the recipient's perspective and cannot by themselves "fix" intended purpose.

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. That phrase is not defined in the MDR or in Medical Device Coordination Group guidance but is the language the CJEU used to express the objective-capability check.

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 in 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. The absence of a clinical evaluation ordered by the manufacturer was consistent with a non-medical purpose, though the CJEU confirms that missing clinical evaluation does not of itself exclude qualification as a device.

Administrative versus clinical function

The Wettbewerbszentrale sought to transpose the reasoning of the court in Snitem and Philips France (C-329/16) from software 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-specific 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 wristbands, supplied unprinted, did not process or otherwise include patient data and generated no information of any kind for a clinician. They performed only the administrative function of identification, achievable equally by a nameplate or badge. Use in a medical context was, again, insufficient. Under the same Snitem reasoning (paragraph 26, recalled at paragraph 45 of the judgement), software confined to archiving, collecting or transmitting data, including software that merely indicates the generic name of a medicine the clinician already intends to prescribe, remains outside the definition. The manufacturer's use-related data had to indicate a medical intended purpose and the product had, objectively, to be capable of performing one of the medical functions listed in Article 2 (1); neither condition was met here.

Distributors and mixed catalogues

Article 14 of the MDR addresses general obligations of distributors, among them verification that products bear CE marking and are accompanied by an EU declaration of conformity. Those obligations presuppose that the products made available on the market are medical devices. Once the wristbands fell outside Article 2 (1), Diagramm Halbach's alleged failure to check CE marking did not crystallise as a breach of article 14 MDR.

The claim reached the CJEU through a German unfair competition action. Under the UWG, breach of a statutory rule that regulates market conduct in the interests of market participants can be challenged as an unfair commercial practice where the breach is liable to affect the interests of consumers, other market participants or competitors. Here, article 14 of the regulation was the market conduct rule relied on for the German UWG claim.

Affixing a CE marking to a product that lacks a medical function carries commercial risk, from unfair competition exposure under domestic laws to potential regulatory scrutiny in selected EU member states. Conversely, removing medical language from a product that falls within article 2 (1) will not take it outside the MDR either. Distributors that carry a mixed portfolio of medical devices and non-medical goods face a practical question of where article 14 duties apply, since those duties are triggered only for products that are medical devices. How each distributor operationalises that threshold is a matter for the operator concerned.

Pending draft revisions of importer and distributor roles under the MDR and IVDR are aimed at supply chain resilience. Those changes sit downstream of article 2 (1) and do not disturb the "qualification first" sequence confirmed in Diagramm Halbach. Furthermore, the judgement leaves open the position of pre-printed wristbands already bearing clinical data, integrated identification systems that themselves perform a medical function, multi-module software platforms and MDR Annex XVI products without an intended medical purpose. Ongoing EU legislative workstreams on more predictable qualification and classification, including those associated with the so-called Helsinki procedure, may limit how often those borderline configurations return to national courts.

Osborne Clarke comment

Diagramm Halbach carries a relevance that extends beyond the wristbands under review by the court. One of the CJEU's key points in this case is that the manufacturer's stated intended purpose and the product's objective medical function must both be made out before the product falls within the MDR. This is a discipline that courts and regulators may now apply more consistently across the medtech and diagnostics sector to devices with an obvious clinical role as well as those near the qualification line.

Mainstream manufacturers whose products plainly serve a therapeutic or diagnostic purpose would do well to take note of the judgement. It shows that general patient-safety framing in marketing collateral – here, the "five rights" of medication administration in Zebra's promotional document – will be discounted where it does not describe what the product does in use.

That same reading of intended purpose can be mapped onto article 7 of the MDR on claims, which prohibits misleading text, names, trademarks, pictures and other signs in labelling, instructions for use, making available, putting into service and advertising as regards a device's intended purpose, safety and performance. Article 7 (d) in particular ties presentation back to the intended purpose for which conformity assessment was carried out, and notified bodies may test that consistency during surveillance and re-certification – an expectation reflected in Team-NB best-practice guidance on MDR annexes II and III technical documentation. In practical terms, businesses may wish to check that labels, instructions for use, marketing materials and other materials used when making the device available or putting it into service describe the intended purpose recorded in the technical documentation, since divergences of that kind can lead to requests for corrective action or restrictions on the certificate.

For businesses nearer the boundary, the judgement sets out two elements that are likely to become the standard test for contested medical status. The first is a stated intended purpose supported by use-related manufacturer data. The second is an objective capability to perform one of the medical purposes listed in article 2 (1). The Snitem line restated in this decision continues to guide software cases.

Distributors form a third audience. Their obligations under article 14 of the MDR depend on a prior qualification finding and this recent referral to the CJEU confirms that such findings can be forced into the open through ordinary domestic litigation, including on grounds of unfair competition. Rather than a fully-fledged review of existing files, it may be more useful for businesses to look again at products whose intended purpose has evolved since first placement, at products whose promotional materials lean heavily on general patient-safety themes rather than on a description of use and at distributor arrangements resting on an upstream qualification call that has never been formally documented. Businesses seeking clarity on how the judgement's reasoning applies to a particular product or distribution arrangement may find tailored legal and regulatory advice to be a useful starting point.