In two recent preliminary ruling proceedings, the ECJ has clarified key aspects of Regulation (EU) 2017/745 (MDR): In the context of competition law disputes, the Court, on the one hand, clarified the duties of care incumbent on distributors in relation to the CE marking and, on the other hand, specified the conditions under which a product is to be classified as a medical device, in particular the requirements regarding the specific medical purpose necessary for such classification.
Facts of the case
The main proceedings concern a competition law dispute between Dürr Dental and the German distributor of compressors manufactured by the Italian company Cattani SpA. Dürr Dental, as the claimant, argued that the compressors sold were to be classified as accessories to medical devices and, due to a lack of conformity under the MDR, did not meet the regulatory requirements. Although the products bore the CE marking, the EU declaration of conformity referred exclusively to Directive 2006/42/EC (Machinery Directive); furthermore, the identification number of a Notified Body, which is required for Class IIa products, was missing. The distributor, however, pointed out that the manufacturer had not placed the products on the market as medical devices and that the Federal Institute for Drugs and Medical Devices (BfArM) did not share the objections. In view of the divergent decisions of the lower courts, the Federal Court of Justice (BGH) referred several questions to the Court of Justice of the European Union (CJEU) regarding the interpretation of the distributor’s obligations under Article 14 of the Medical Devices Regulation (MDR) in a preliminary ruling procedure.
Decision
No systematic review of the manufacturer’s classification, but a ‘consistency check’
In its judgment, the ECJ clarifies that Article 14(2), first subparagraph, point (a) of the MDR merely obliges distributors to check whether the product in question bears a CE marking and is accompanied by an EU declaration of conformity. However, they are not required to carry out a substantive review of the conformity assessment; responsibility for this remains, in principle, with the manufacturer.
Nevertheless, the duty of care under Article 14 of the MDR requires a ‘consistency check’ to be carried out prior to making the product available on the market, based on the information available to or accessible by the distributor. This includes, in particular, the EU Declaration of Conformity, the CE marking, the instructions for use and, where applicable, information on the manufacturer’s website or in promotional materials. On the basis of these documents, the distributor must be able to identify obvious inconsistencies, for example where a product is clearly intended for medical purposes but is not treated as a medical device.
However, a breach of the duty of care can only be considered if the incorrect classification is obvious.
No obligation to verify the risk classification
In response to the third question referred for a preliminary ruling, the ECJ clarifies that distributors are not obliged to verify the accuracy of a product’s risk classification. Such a verification would go beyond the consistency check required under Article 14 of the MDR, as it would require detailed knowledge of the product’s design, functioning and intended purpose, which is usually only available to the manufacturer. Furthermore, such an obligation would blur the division of responsibilities between economic operators as provided for by the MDR.
However, the situation is different if the information available to the distributor indicates that the product has been classified in a class requiring the involvement of a Notified Body (Class IIa, IIb or III). In this case, the distributor must check whether the four-digit identification number of the Notified Body is affixed to the CE marking.
Effect of warning letters and statements from regulatory authorities
The ECJ thus confirms that a warning letter from a competitor may give a distributor ‘reason to believe’ that a product is not MDR-compliant. The distributor must therefore take the warning letter into account and assess independently whether it justifies reasonable doubts as to conformity.
If, upon enquiry, the manufacturer states that the alleged non-compliance does not exist, the distributor may, in principle, rely on this assessment, provided it does not appear manifestly incorrect.
If the trader notifies the competent authority in accordance with Article 14(2), third subparagraph, of the MDR, any existing doubts are fully dispelled by a reasoned and unambiguous statement from the authority refuting the alleged non-compliance.
Facts of the case
In the main proceedings, the Competition Centre is taking action against Diagramm Halbach GmbH & Co. KG, which distributed unprinted patient wristbands manufactured by Zebra Technologies. The wristbands could be printed with patient information and were used to identify patients. Prior to placing them on the market, the distributor had not checked for the presence of either a CE marking or an EU declaration of conformity.
The Competition Centre relied in particular on the manufacturer’s advertising claims, according to which patient identification using the wristbands could improve patient safety and reduce medical errors, and argued that the sale of the patient wristbands without authorisation under medical device legislation was anti-competitive.
Decision
The intended purpose is decisive, but not solely the manufacturer’s statement
The ECJ clarifies that the intended purpose stated by the manufacturer is an important, but not the sole, component of the definition of a medical device. Only information that actually relates to the use of the product is decisive. Mere advertising claims or general references to benefits in a medical context are not sufficient. Furthermore, manufacturers’ specifications must be interpreted from the perspective of the relevant public.
Patient wristbands fulfil only an administrative function
In the view of the ECJ, patient wristbands serve solely to identify patients. They are supplied unprinted, do not serve any of the medical purposes set out in Article 2(1) of the MDR, and do not perform any independent diagnostic or therapeutic function. A patient could be identified just as easily by other means of identification. The wristbands therefore merely fulfil an administrative function and do not constitute either medical devices or accessories for medical devices.
Objective suitability as an additional criterion
It is particularly worth noting that the ECJ subjects the concept of ‘intended use’ to objective limits. Even if a medical purpose is attributed to a product, it must also be objectively suitable for fulfilling that purpose. The MDR thus requires both a corresponding intended use and the objective suitability of the product.
Distinction from the Snitem case law
The ECJ rejects the reference to the Snitem and Philips France judgment (C-329/16). Unlike the software at issue in that case, which assisted doctors in making medical decisions through data processing, patient wristbands merely fulfil administrative functions. The mere use of a product in a medical setting is not sufficient for it to be classified as a medical device.
The decision in Case C-10/24 (Dürr Dental) underlines the importance of consistent product classification and CE marking. Obvious discrepancies between the CE marking, the EU declaration of conformity and the instructions for use may trigger distributors’ duties of care and thus also give rise to competition law risks, potentially leading to sales bans. Manufacturers should ensure that all product-related documentation, including websites and promotional material, reflects a consistent and accurate regulatory classification, as this serves as the basis for the ‘consistency check’ required by the ECJ.
At the same time, the ECJ clarifies the obligations of distributors under Article 14 of the MDR: Distributors are not required to systematically verify a product’s classification; however, they must be vigilant for obvious inconsistencies on the basis of the documentation available to them, in particular the EU Declaration of Conformity, the CE marking and the instructions for use. In practice, distributors should, in particular, check whether the CE marking and the declaration of conformity relate to the same regulatory framework and whether this is consistent with the product’s apparent intended use. This is all the more relevant when competitors issue a warning letter, as such letters, in the view of the ECJ, may constitute ‘grounds for assuming’ non-compliance.
At the same time, the ruling strengthens the legal position of retailers. They may, in principle, rely on the manufacturer’s statement, provided that it is not manifestly incorrect. Furthermore, if the competent authority is involved and refutes the alleged non-conformity in a reasoned and unambiguous statement, any existing doubts are unreservedly dispelled. Where there are reasonable doubts as to the conformity of a product, distributors should involve both the manufacturer and the competent authority and document the statements received in order to be able to demonstrate that they have fulfilled their due diligence obligations.
The judgment in Case C-427/24 (patient wristbands) further clarifies the requirements for medical intended purpose within the meaning of the MDR. General advertising claims that place a product in a medical context do not, in themselves, establish a medical intended purpose. Furthermore, a product must be objectively suitable for fulfilling the claimed medical purpose. A mere assertion by the manufacturer is not sufficient. This is particularly relevant for so-called borderline products. Manufacturers should check whether their product classification complies with the criteria developed by the ECJ and carefully review their advertising material, as manufacturers’ claims must also be interpreted from the recipient’s perspective.
The lack of clarity regarding the specific medical intended purpose to date has led to considerable legal uncertainty, particularly in the case of borderline products. In some instances, virtually identical products were classified differently for regulatory purposes, which encouraged distortions of competition and disputes under competition law. Furthermore, the CE marking was sometimes sought for marketing reasons. The ECJ explicitly addresses this point and refers to the possibility that a CE marking might ‘in certain circumstances have been affixed purely for marketing reasons’ (para. 28). The current clarification of the definition of a medical device and the requirement for objective suitability are likely to contribute to greater legal certainty. As the ECJ has set out general principles of interpretation, the judgment is likely to have significance far beyond the specific case of patient wristbands.
(ECJ, judgment of 4 June 2026 – Case C-10/24 – Dürr Dental)
(ECJ, judgment of 2 July 2026 – Case C-427/24 – Patient wristbands)
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