How far do a distributor’s obligations extend before making a medical device available on the market? This question was referred to the Court of Justice of the European Union (CJEU) by the German Federal Court of Justice (BGH) in its request for a preliminary ruling of 21 December 2023. Following the publication of the judgment on 4 June 2026 (Case C-10/24), a significant and authoritative answer is now available. The decision is of considerable practical importance for all companies involved in the medical device supply chain, as Article 14 of Regulation (EU) 2017/745 on medical devices (MDR) has now been subject to an in-depth interpretation by the CJEU. This article outlines the Court’s key considerations regarding the scope and limits of distributors’ obligations.
Overview of the Facts
The proceedings arose from a dispute between a German manufacturer of compressed-air compressors for dental treatment and a German company acting as an independent sales representative for an Italian manufacturer of oil-free dry-air compressors. According to their intended purpose, these compressors are used for various applications in the context of dental treatment. Although the compressors bore a CE marking, this marking was not based on a declaration of conformity under the MDR. Instead, the declaration of conformity referred solely to Directive 2006/42/EC on machinery. Furthermore, the four-digit identification number of a notified body – which would have been mandatory for Class IIa medical devices – was absent.
According to the claimant manufacturer, the intended purpose of the marketed dry-air compressors already indicated that they qualified as accessories to a medical device within the meaning of the MDR. Consequently, the compressors themselves could only be placed on the market after undergoing the appropriate certification procedure involving a notified body and obtaining a CE marking under the MDR. The claimant argued that the defendant, in its capacity as a distributor, was obliged to verify and ensure compliance with these requirements, which constitute mandatory conditions for lawful marketing. Against this background, the BGH referred several key questions to the CJEU under the preliminary ruling procedure, seeking clarification on the scope and extent of distributors’ obligations under Article 14 MDR.
Distributor’s Duty of Care
In response to the first two questions referred by the BGH, the CJEU held that Article 14(1) and Article 14(2), first subparagraph, point (a), MDR must be interpreted as meaning that, in fulfilling its duty of care, a distributor is required to verify, on the basis of the information available to it, whether the CE marking and the EU declaration of conformity relating to a product it makes available on the market clearly concern a product falling within the scope of the MDR.
The Court first emphasized that responsibility for ensuring a product’s compliance with the requirements of the MDR primarily rests with the manufacturer, given the clear allocation of roles established by the Regulation. The CJEU based this conclusion in particular on the fact that the manufacturer has the best knowledge of its product and is responsible for affixing the CE marking and issuing the EU declaration of conformity. By contrast, pursuant to Article 14(1) MDR, a distributor is merely required to act with “due care” in relation to the applicable requirements. According to the Court, the wording of Article 14(2), first subparagraph, point (a), MDR indicates that a distributor must verify the existence of a CE marking and an EU declaration of conformity, but is not required to assess their substantive correctness. Consequently, the classification of a product as a medical device does not, as a general rule, fall within the distributor’s responsibilities. The checks incumbent upon the distributor are therefore, in principle, of a purely formal nature.
However, with regard to Article 14(2), third subparagraph, MDR – which obliges a distributor to take action where it has reason to believe that a product is not in conformity – the CJEU imposed what may be described as a “consistency check” obligation. The distributor must examine, on the basis of the documentation available to it or readily accessible, whether the CE marking and the EU declaration of conformity manifestly relate to a product covered by the MDR. Relevant sources of information include, in particular, the declaration of conformity, the product labelling, the instructions for use, the manufacturer’s website, and any marketing materials. By contrast, the distributor is not required, as part of its duty of care, to analyse highly technical documentation. A duty to react arises only where a misclassification is apparent on its face.
Accordingly, Article 14(2), third subparagraph, MDR implies that a distributor who has reason to believe that a product does not comply with the requirements of the Regulation may be obliged to take appropriate action before making that product available on the market, even though the distributor is not itself responsible for ensuring the product’s conformity with the applicable regulatory requirements. Such an obligation follows from the distributor’s “due care” duty within the meaning of Article 14(1) MDR.
No Obligation to Verify the Risk Classification
In response to the third question referred by the BGH, the CJEU further held that Article 14(2), first subparagraph, point (a), in conjunction with Article 14(1) MDR, must be interpreted as meaning that a distributor is not required to verify whether a product it makes available on the market falls within a particular risk class. However, where the information available to the distributor indicates that the manufacturer has classified the product in a risk class requiring the involvement of a notified body, the distributor’s duty of care includes verifying the presence of that body’s four-digit identification number.
In this regard, the CJEU stated that the obligations imposed on distributors under Article 14 MDR do not extend to verifying the correctness of the manufacturer’s classification of a product into a specific risk class. The classification of a medical device requires detailed knowledge of the product’s design, operation, and intended purpose and is sufficiently complex that, in the event of a dispute between the manufacturer and the notified body, the competent authority of the Member State may ultimately be called upon to decide the matter. Imposing such an assessment on distributors would significantly broaden their obligations under the MDR and correspondingly increase their potential liability.
According to the Court, such an interpretation would be contrary to the objectives of the MDR. Requiring distributors to review risk classifications would blur the distinction between the responsibilities assigned to the various economic operators, thereby undermining the objective of clarity and, consequently, the objective of legal certainty with regard to those obligations. An exception may nevertheless apply in the following situation: where the information provided to the distributor shows that the manufacturer has itself classified the product in a risk class for which the involvement of a notified body is mandatory (Classes IIa, IIb, or III), the distributor must, as part of its duty of care, verify that the CE marking bears the corresponding identification number of that notified body. Such a formal verification remains within the scope of Article 14(2), first subparagraph, point (a), MDR.
Distributor Obligations in the Presence of Indications of Possible Non-Compliance
Finally, the CJEU held that Article 14(2), third subparagraph, MDR must be interpreted as meaning that a distributor may have reason to believe that a product does not comply with the MDR where a competitor issues a warning letter alleging the product’s non-compliance. Where the manufacturer consulted by the distributor takes the view that the alleged non-compliance does not exist, the distributor cannot be accused of breaching its obligations under that provision by relying on the manufacturer’s assessment, unless that assessment appears manifestly incorrect. Furthermore, where the distributor has informed the competent national authority pursuant to that provision, any doubts regarding the conformity of the product are conclusively dispelled if the authority issues a reasoned and unequivocal opinion rejecting the alleged non-compliance.
Conclusion
The CJEU’s answers to the questions referred by the BGH, and the resulting clarification of the scope of distributors’ verification obligations under the MDR, provide distributors of medical devices and their accessories with a significantly greater degree of legal certainty. The judgment clearly delineates the responsibilities of distributors. At the same time, the Court refines the contours of those responsibilities by introducing the requirement of a “consistency check,” thereby raising the standard of due care and requiring distributors to identify and respond to readily apparent inconsistencies between a product’s intended purpose, its presentation, and its regulatory classification. Against this background, distributors of medical devices should critically review their verification, communication, and documentation processes and, where necessary, adapt them to the standards established by the CJEU.
