In its decision of December 21, 2023 (Ref.: I ZR 17/23), the Federal Court of Justice (BGH) referred to the Court of Justice of the European Union (ECJ) concerning the inspection obligations of distributors of medical devices within the meaning of Art. 14 of Regulation (EU) 2017/745 (hereinafter: MDR). The background to this referral order is a competition law dispute between two competing companies.
Brief excursus: Unclear situation also in the area of cosmetics advertising
In this context, another recent order for a preliminary ruling by the Federal Court of Justice (BGH, order of June 18, 2025 – I ZR 78/24 "Promotion of cell renewal") is also of interest: This decision concerns the distribution of responsibility between manufacturers and distributors in the field of cosmetics advertising and deals with the exciting and unresolved question of whether a distributor is liable if it adopts an advertising statement from the manufacturer without checking it and it later proves to be misleading – in this case, the claim of "cell renewal" pursuant to Art. 20 (1) of the Cosmetics Regulation.
This referral order is therefore closely related to the BGH referral concerning medical devices, on which the ECJ has not yet issued a decision, but for which the Opinion has already been issued. This could also set a precedent for the distribution of responsibility between manufacturers and distributors in the field of cosmetics advertising.
Facts
The plaintiff manufactures compressors for the production of compressed air for dental treatment, which, according to the decision of the Federal Institute for Drugs and Medical Devices (BfArM), are medical devices in risk class IIa.
The defendant, as the legally independent German representative of the Italian manufacturer, distributes so-called oil-free dry air compressors for the generation of compressed air in Germany. According to their intended purpose, as stated in the instructions for use and on the manufacturer's website, these are used to supply compressed air for dental handpieces, to operate rotating instruments used by dentists, and to dry preparations before cementing as part of dental treatment. Although the compressors bore a CE mark, this was not based on a declaration of conformity under the MDR for medical devices, but rather the declaration of conformity referred only to Directive 2006/42/EC on machinery. The compressor supplied by the defendant also did not bear the identification number of a notified body, which must be attached to the CE marking for a medical device in risk class IIa within the meaning of the MDR.
The plaintiff is of the opinion that the dry air compressors distributed by the defendant are to be regarded as accessories for medical devices within the meaning of the MDR, which are to be classified in risk class IIa, due to their intended purpose. It follows from this that the compressors themselves may only be made available on the market after appropriate certification by a notified body, including CE marking. As a distributor, the defendant has a duty to verify and ensure compliance with these provisions, which are a mandatory requirement for permissible distribution.
The defendant, on the other hand, is of the opinion that the obligations of the distributor under the MDR only apply to products that have been expressly placed on the market as medical devices by the manufacturer. In any case, the decision as to whether a product is a medical device is a complex legal question that is not easy to answer. Answering this question requires comprehensive knowledge of the product characteristics that is only available to the manufacturer. This applies all the more to the question of whether a medical device should be classified in risk class IIa within the meaning of the MDR. This assessment cannot be made by a distributor and is not part of its obligations.
Decision of the Higher Regional Court of Celle in the appeal proceedings
In its appeal ruling of January 19, 2023 (Ref.: 13 U 79/21), the Higher Regional Court of Celle assumed that the dry air compressors at issue were accessories to a medical device within the meaning of Art. 2 No. 2 MDR due to their medical purpose as stated in the instructions for use, and ruled that they could not be made available on the market as medical devices without a declaration of conformity under medical device law and CE marking.
However, the obligation incumbent on the defendant as a distributor pursuant to Art. 14 (1) and (2) MDR to check with due diligence before making the compressors available whether they bore the CE marking and whether an EU declaration of conformity had been issued for the product only comprised a formal check. This requires the defendant, as a distributor, to have a basic knowledge of which products must bear a CE marking and require a declaration of conformity under medical device law. To this end, it must be able to identify medical devices and their accessories on the basis of the instructions for use. It must then obtain an EU declaration of conformity in accordance with the MDR from the manufacturer of these products before making them available.
On the other hand, the distributor is not obliged to evaluate the content of an EU declaration of conformity provided by the manufacturer, including the risk classification. By issuing the EU declaration of conformity, the manufacturer assumes responsibility for ensuring that its product complies with all applicable EU regulations, Art. 19 (3) MDR.
Appeal decision by the Federal Court of Justice
The Federal Court of Justice had to decide on the appeal lodged in this case. It confirmed the opinion of the Higher Regional Court of Celle insofar as it classified the oil-free dry air compressor as an accessory to a medical device within the meaning of Art. 2 No. 2 MDR. In classifying this product, the Federal Court of Justice also focuses on the manufacturer's intended purpose, as specified in particular in the instructions for use.
However, the Federal Court of Justice suspended the appeal proceedings on December 21, 2023, in order to obtain a preliminary ruling from the European Court of Justice pursuant to Art. 267(1)(b) and (3) TFEU. This is because the success of the appeal depends largely on the interpretation of Art. 14(1) and (2)(a) and (3)(1) MDR. The BGH has therefore referred questions to the ECJ for a preliminary ruling, which should clarify the content and scope of the distributor's obligations under Art. 14 MDR.
The ECJ now has to answer the question of whether a distributor is obliged under Article 14(1) and (2) MDR to check whether the product it places on the market is to be regarded as a medical device and therefore bears a CE marking as a medical device and whether the manufacturer has issued an EU declaration of conformity for a medical device. Furthermore, the ECJ will have to decide whether the manufacturer's product classification has any influence on this obligation of the distributor to check.
According to the Federal Court of Justice, this cannot be expressly inferred from the wording of Art. 14 (1) and (2) MDR. However, it should be noted that Art. 14 (1) MDR does not stipulate an unrestricted obligation on the part of the distributor to check, but limits this in two respects. On the one hand, the distributor only has to take the applicable requirements into account within the scope of its activities. Secondly, the distributor only has to exercise due diligence. The scope of these limitations will now have to be determined by the ECJ.
Furthermore, the ECJ must decide whether the distributor's verification obligations also include the question of whether the product is to be classified in a specific risk class within the meaning of the MDR. In its order for reference, the BGH states that, in its opinion, the following aspect must be taken into account when assessing the scope of these distributor verification obligations: Risk classification is generally more complex, both legally and in practice, than the classification of a product as a medical device or accessory to a medical device. In this context, the Federal Court of Justice believes that it should be taken into account that classification requires an assessment of issues which, unlike the assessment of the requirements for a medical device or an accessory to a medical device , – cannot be examined solely on the basis of the intended purpose documented by the manufacturer, for example in the instructions for use or advertising and sales materials, and thus on the basis of documents that are available to a distributor and should be easy to understand. Rather, classification should not be carried out by the manufacturer alone, but with the involvement of the notified body.
Opinion of the Advocate General
The ECJ's answers to the questions referred and thus the clarification of the scope of distributors' verification obligations under the MDR are eagerly awaited. This is because the decision will set the tone for the content and scope of distributors' verification obligations when distributing medical devices and define their responsibilities in this context.
The Opinion of Advocate General Dean Spielmann of September 11, 2025, now provides an indication of possible answers from the ECJ.
After a detailed analysis of Article 14(1) and (2) of Regulation 2017/745, taking into account the wording, structure, and purpose of the provision, the Advocate General proposes that the Court of Justice answer the first, second, and third questions referred by the Bundesgerichtshof (Germany) as follows:
- Article 14(1) and (2)(a) of Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017, on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
is to be interpreted as meaning that
the distributor must, as part of its duty of care, check, on the basis of the information available to it, whether the CE marking and the EU declaration of conformity for the product it has made available on the market clearly refer to a product covered by that regulation.
- Article 14(2), first subparagraph, point (a), in conjunction with Article 14(1) of Regulation 2017/745
must be interpreted as meaning that
the distributor's verification obligations do not include the question of whether the product is to be classified in risk class IIa within the meaning of this Regulation. However, if the information provided to the distributor indicates that the product has been classified by the manufacturer in a risk class that requires the involvement of a notified body, the distributor must, as part of its duty of care, verify whether the identification number of that body is indicated.
Conclusion
If the ECJ follows the Advocate General's recommendations, distributors will have to be prepared in future to carry out a consistency check on the basis of the information available to them, even though they are not obliged to repeat or fully replicate the manufacturer's tests. However, they may not place the medical devices on the market without further testing in the event of contradictions and unresolved doubts.
In its final decision, the Federal Court of Justice will have to assess, taking into account the circumstances, what efforts the distributor must make in the context of its duty of care within the meaning of Article 14(1) of Regulation 2017/745. The basic knowledge expected of a distributor of medical devices, the content of the documents available to them, and the technical difficulties arising in individual cases are all relevant factors in assessing the extent of the efforts that can be expected of a "reasonable or prudent" distributor.
It is noteworthy in this context that, as mentioned above, the Federal Court of Justice (BGH) also initiated a similar preliminary ruling procedure in the field of cosmetics advertising with its decision of June 18, 2025 (Ref.: I ZR 78/24 – "Promotion of cell renewal").
The referral decision makes it clear that the fundamental problem of distinguishing between the testing and responsibility obligations of manufacturers and distributors is not limited to medical device law. Rather, there is a need for regulation and clarification throughout the EU regarding distributor responsibility in the marketing of both medical devices and cosmetic products. If the upcoming decisions of the ECJ lead to a more uniform interpretation, they could provide authoritative guidelines for the practice of distributor testing in the entire field of product-related regulation in the future.
