By order of December 21, 2023 (Case No. I ZR 17/23), the Federal Court of Justice (BGH) referred five questions concerning the due diligence obligations of distributors of medical devices within the meaning of Article 14 of Regulation (EU) 2017/745 (hereinafter: MDR) to the Court of Justice of the European Union (CJEU) for a preliminary ruling. The background to this referral is a competition law dispute between two competing companies.

Facts of the Case

The plaintiff manufactures compressors for generating compressed air for dental treatment, which, according to a decision by the Federal Institute for Drugs and Medical Devices (BfArM), are medical devices classified as risk class IIa.

The defendant distributes so-called oil-free dry air compressors for generating compressed air in Germany as the legally independent German sales representative of the Italian manufacturer. According to their intended purpose, as derived from the user manual and the manufacturer’s website, these compressors are used to supply compressed air for dental handpieces, to operate rotating instruments used by dentists, and to dry preparations before cementation during dental treatment. Although the compressors bore a CE marking, this was not based on a medical device conformity declaration according to the MDR but rather referred only to Directive 2006/42/EC on machinery. The compressor delivered by the defendant also did not display the identification number of a notified body, which must be affixed to the CE marking of a medical device classified as risk class IIa under the MDR.

The plaintiff holds the view that the dry air compressors distributed by the defendant, due to their intended purpose, qualify as accessories to medical devices within the meaning of the MDR and should be classified as risk class IIa. It follows that the compressors themselves may only be placed on the market after appropriate certification involving a notified body and bearing the CE marking. As a distributor, the defendant has the duty to verify and ensure compliance with these provisions, which are mandatory prerequisites for lawful distribution.

The defendant, on the other hand, is of the view that the obligations of the distributor under the MDR apply only to products that have been explicitly placed on the market by the manufacturer as medical devices. In any case, the determination of whether a product qualifies as a medical device is a complex legal question that is not easily answered. Its resolution requires comprehensive knowledge of the product characteristics that is available only to the manufacturer. This is especially true for the question of whether a medical device should be classified as risk class IIa within the meaning of the MDR. Such an assessment cannot be performed by a distributor and does not fall within their duties.

Decision of the Higher Regional Court of Celle in the appellate instance

In the appellate instance, the Higher Regional Court of Celle qualified the dry air compressors at issue as accessories to a medical device within the meaning of Article 2 No. 2 MDR, based on their medical intended purpose as set out in the user manual, and ruled in its judgment of January 19, 2023 (Case No. 13 U 79/21) that they may not be placed on the market as medical devices without a medical device conformity declaration and CE marking.

The obligation of the defendant as a distributor under Article 14 para. 1 and 2 MDR to verify, with due diligence before placing the products on the market, whether the compressors bear the CE marking and whether an EU declaration of conformity has been issued for the product, however, only encompasses a formal check. This requires the distributor to have basic knowledge of which products must be affixed with a CE marking and require a medical device conformity declaration. The distributor must be able to identify medical devices and their accessories based on the user manual. The distributor must then obtain an EU declaration of conformity under the MDR from the manufacturer before placing the products on the market.

However, the distributor is not required to conduct a substantive assessment of the manufacturer’s EU declaration of conformity, including the risk classification. By issuing the EU declaration of conformity, the manufacturer assumes responsibility that their product complies with all applicable Union law requirements, pursuant to Article 19 para. 3 MDR.

Revision decision of the BGH

The BGH was now tasked with deciding on the appeal filed in this matter. It confirmed the view 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 Article 2 No. 2 MDR. In this product classification, the BGH also primarily referred to the manufacturer’s intended purpose, as particularly indicated by the user manual.

However, on December 21, 2023, the BGH stayed the appeal proceedings in order to request a preliminary ruling from the CJEU pursuant to Article 267 para. 1 lit. b) and para. 3 TFEU. The success of the appeal largely depends on the interpretation of Article 14 para. 1 and 2, first subparagraph (a), and third subparagraph, first sentence, of the MDR. Therefore, the BGH referred five questions to the CJEU for a preliminary ruling to clarify the content and scope of the distributor’s obligations under Article 14 MDR.

The CJEU is now specifically required to answer whether a distributor under Article 14 para. 1 and 2 MDR is obliged to verify whether the product they place on the market qualifies 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 CJEU will have to decide whether the manufacturer’s product classification affects this verification obligation of the distributor.

The BGH stated that this is not explicitly evident from the wording of Article 14 para. 1 and 2 MDR. However, it must be taken into account that Article 14 para. 1 MDR does not impose an unrestricted obligation on the distributor to carry out checks, but limits this obligation in two respects. On the one hand, the distributor is only required to consider the applicable requirements within the scope of their activities. On the other hand, the distributor must exercise due diligence. The CJEU will now have to determine the extent of these limitations.

Furthermore, the CJEU must decide whether the distributor’s obligations to verify also include the question of whether the product should be classified into a specific risk class under the MDR. In its referral decision, the BGH explained that, in its view, the following aspect is decisive for assessing the scope of these distributor verification duties: The risk classification is generally both legally and factually more complex than the qualification of a product as a medical device or accessory to a medical device. According to the BGH, it should be considered in this context that classification requires an assessment of issues that – unlike the assessment of the criteria for a medical device or accessory – cannot be examined solely based on the manufacturer’s documented intended purpose, for example, in the user manual or promotional and sales materials. These documents should be accessible to and easily understood by a distributor. Rather, classification usually has to be carried out not only by the manufacturer alone but also with the involvement of the notified body.

Conclusion

The answers to the preliminary questions by the CJEU – and thus the clarification of the scope of distributors’ verification duties under the MDR – remain highly anticipated. The decision will be groundbreaking for defining the content and extent of distributors’ obligations when marketing medical devices and will clarify their responsibilities in this context.