How far do a distributor’s obligations extend before they are allowed to place a medical device on the market? This question is currently before the Court of Justice of the European Union (CJEU) and has considerable practical relevance for companies in the medical device supply chain. In his Opinion of 11 September 2025 (C-10/24), the Advocate General of the CJEU undertook a detailed interpretation of Article 14 of Regulation (EU) 2017/745 on medical devices (MDR).
Overview of the Fact
The proceedings arise from a legal dispute between a German manufacturer of compressed air compressors for dental treatment and a German company acting as an independent factory representative distributing oil-free dry air compressors of an Italian manufacturer. 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 was not based on a declaration of conformity under the MDR; rather, the declaration of conformity referred only to Directive 2006/42/EC on machinery. A four-digit identification number of a notified body – mandatory for Class IIa medical devices – was missing.
According to the claimant manufacturer, the intended purpose of the distributed dry air compressors already indicated that they should be classified as accessories to a medical device within the meaning of the MDR. Consequently, the compressors themselves could only be placed on the market after appropriate certification involving a notified body and bearing a CE marking in accordance with the MDR. The defendant, as a distributor, was obliged to verify and ensure compliance with these requirements, which constitute a mandatory condition for lawful distribution. Against this background, the German Federal Court of Justice (BGH) referred key questions concerning the scope and extent of distributors’ obligations under Article 14 MDR to the CJEU for a preliminary ruling.
Distributor’s Due Diligence Obligations
With its first two questions, the referring court essentially asks the CJEU whether Article 14(1) and Article 14(2), first subparagraph, point (a) MDR are to be interpreted as requiring a distributor to verify whether a product it makes available on the market qualifies as a medical device, and whether it is relevant to this assessment that the manufacturer has affixed a CE marking as a medical device, as an accessory to a medical device, or as a machine within the meaning of the Machinery Directive.
The Advocate General’s assessment starts from the clear allocation of roles between manufacturers and distributors under the MDR. Responsibility for ensuring that a product complies with the requirements of the Regulation primarily lies with the manufacturer, who knows the product best and is responsible for the CE marking and the EU declaration of conformity. Under Article 14(1) MDR, the distributor is merely required to take the applicable requirements into account “with due care.” According to the Advocate General, the wording of Article 14(2), first subparagraph, point (a) MDR indicates that the distributor must verify the existence of a CE marking and an EU declaration of conformity, but not their substantive correctness. Consequently, assessing whether a product qualifies as a medical device does not, in principle, fall within the distributor’s responsibilities. Rather, the checks incumbent upon the distributor are generally of a purely formal nature.
With regard to Article 14(2), third subparagraph MDR – which obliges the distributor to take action where it has reason to believe that a product is not in conformity – as well as the EU’s 2022 guidance on the implementation of product rules (the “Blue Guide”), the Advocate General further develops the concept of a limited “consistency check.” According to this, the distributor is required to verify, on the basis of the documentation available to it or easily accessible, whether the CE marking and the EU declaration of conformity clearly relate to a product covered by the MDR. Relevant sources of information include, in particular, the declaration of conformity, product labeling, instructions for use, the manufacturer’s website, and any marketing materials. However, the distributor is not required to analyze highly technical documentation as part of its due diligence obligations. A duty to act arises only in cases of obvious misclassification.
Applied to the case at hand, this means: if it was clearly evident from the instructions for use that the compressors were intended for use with a dental treatment unit – i.e., a medical device – then, at least in the Advocate General’s view, a diligent distributor should have recognized the inconsistency between that intended purpose and the CE marking based on the Machinery Directive.
No Obligation to Verify the Risk Classification
By its third question, BGH seeks to clarify whether Article 14(2), first subparagraph, point (a), in conjunction with Article 14(1) MDR must be interpreted as meaning that a distributor’s verification obligations also include assessing whether a product falls within risk class IIa under the Regulation and must therefore bear a four-digit identification number of a notified body.
In this context, the Advocate General makes clear that the distributor’s obligations under Article 14 MDR do not extend to verifying whether the manufacturer’s classification of the product into a specific risk class is correct. The classification of a medical device requires detailed knowledge of the product’s design, mode of operation, and intended purpose, and is so complex that, in the event of a dispute between the manufacturer and the notified body, the competent authority of the Member State ultimately decides. Imposing such an obligation on distributors would significantly expand their duties under the MDR and correspondingly increase their liability.
An exception may apply in the following scenario: where the information provided to the distributor indicates that the manufacturer itself has classified the product in a risk class that mandatorily requires the involvement of a notified body (Classes IIa, IIb, or III), the distributor must, as part of its due diligence, verify whether the CE marking includes the corresponding identification number of that body. This type of formal check still falls within the scope of Article 14(2), first subparagraph, point (a) MDR.
Conclusion
The CJEU’s answers to the questions referred, and thus the clarification of the scope of distributors’ verification obligations under the MDR, are still eagerly awaited. Whether the Court will follow the Advocate General’s approach remains to be seen; however, in light of the convincing systematic and teleological reasoning, which ultimately leads to a differentiated and practically manageable set of obligations for distributors of medical devices, this appears likely. Distributors of medical devices would therefore be well advised to already align their compliance processes with the standards developed by the Advocate General.
