EU Court clarifies the scope of distributors’ obligations under the MDR

On 9 January 2024, the Court of Justice of the European Union (CJEU) received a request for a preliminary ruling from the Bundesgerichtshof (German Federal Court of Justice). The request concerned the interpretation of the obligations of medical devices’ distributors under Article 14(1) and (2) of the EU Medical Devices Regulation (MDR).  

The case arose from a dispute between Dürr Dental SE (hereinafter “Dürr Dental”) and Cattani Deutschland Helmes GmbH & Co. KG (hereinafter “Cattani Deutschland”) regarding the marketing of oil-free dry air compressors intended for use in dental treatment. While Dürr Dental’s own compressors had been classified as Class IIa medical devices, competing compressors distributed by Cattani Deutschland were marketed under the machinery legislation and bore a CE marking accordingly. Dürr Dental argued that Cattani Deutschland was unlawfully distributing dental air compressors as machinery, rather than as medical devices under the MDR.  

Therefore, the request for the CJEU ruling centred on whether distributors may rely on the manufacturer’s regulatory qualification of a device and, more broadly, on the scope of the obligations imposed on distributors under Article 14 MDR.  

Questions referred to the CJEU about distributors’ obligations established by Article 14 MDR 

The Bundesgerichtshof (hereinafter “the Court”) requested guidance from the CJEU on several aspects of distributors’ obligations established by Article 14 MDR. In essence, the questions focused on the following issues: 

1. Verification of CE marking and conformity documentation. The Court asked whether, as part of their obligation to act with due care, distributors must verify that the product they make available on the market is to be regarded as a medical device, and that the CE marking and the accompanying EU Declaration of Conformity relate to the scope of the MDR.
2. Verification of device classification. The Court asked if distributors are required to verify that the device they distribute has been correctly classified under the MDR, including confirming the manufacturer’s determination of the applicable risk class, and the inclusion of the four-digit identification number of a notified body. 
3. Circumstances giving rise to a suspect of non-compliance. The Court asked whether a distributor may have reasons to believe that a device is not compliant with the MDR when it receives a formal notice from a competitor alleging non-compliance, even where the manufacturer and a competent national authority consider those allegations to be unfounded.

Under Article 14(2) MDR, distributors must refrain from making a device available on the market where they have reason to believe it is non-compliant. In this case, they must notify the relevant economic operators accordingly. This question sought to clarify when these obligations are triggered and how distributors should assess potentially conflicting information received from competitors, manufacturers, and competent authorities when determining whether a device may be distributed.

Clarifications on the interpretation of Article 14 MDR

In its judgment of 4 June 2026, the CJEU provided important clarifications. It held that:  

1. Distributors must verify that the CE marking and the EU Declaration of Conformity clearly relate to a device falling within the scope of the MDR. This verification forms part of the distributor’s obligation to act with due care. While this shall not require distributors to repeat the manufacturer’s conformity assessment, they must perform a consistency check based on the information available, ensuring that there are no obvious indications of non-compliance.
2. Distributors are not obliged to verify the correctness of the classification decided by the manufacturer of the medical device they distribute. However, if the information available indicates that that device is classified by the manufacturer in a risk class entailing the involvement of a notified body (NB), the distributor must verify that the four-digit identification number of that NB is indicated.
3. A distributor may have reason to believe that a device is not compliant with the MDR where it receives a formal notice from a competitor alleging non-compliance. However, where the manufacturer provides a reasoned response demonstrating that such allegations are not substantiated, the distributor may generally rely on the manufacturer’s position and cannot be considered in breach of its obligations. Furthermore, where the competent national authority issues a reasoned opinion rejecting the alleged non-compliance, any doubts regarding the conformity of the product may be considered resolved.

This judgment provides valuable clarification regarding the implications and limits of distributors’ due diligence obligations under the MDR. While distributors remain responsible for verifying key compliance elements and reacting accordingly, they are not required to independently reassess a product’s qualification or classification decisions.

For any questions on compliance with the MDR and IVDR, contact us here or at mdlaw@obelis.net.

References:

CJEU. (2026). Reference for a preliminary ruling – Medical devices – Regulation (EU) 2017/745 – CE marking of a medical device falling under risk class IIa – Oil-free dry air compressors for the production of compressed air for dental treatment – Making available on the market – Obligations of distributors – Verification of the classification as a ‘medical device’ where the manufacturer has affixed a CE marking to the device in question as ‘machinery’. Retrieved on 21/08/2026.

CJEU. (2026). C/2026/3804. Judgment of the Court (First Chamber) of 4 June 2026 (request for a preliminary ruling from the Bundesgerichtshof – Germany) – Dürr Dental SE v Cattani Deutschland Helmes GmbH & Co. KG. (Case C-10/24,  Dürr Dental). Retrieved on 21/08/2026.