The Court of Justice of the European Union (CJEU) has recently delivered an important judgment clarifying the obligations of distributors of medical devices under the Medical Device Regulation (MDR). In its judgment of 4 June 2026 in Case C-10/24 (Dürr Dental), the Court addressed a practical question that many companies throughout the medical device supply chain have been struggling with since the MDR entered into force: How far must distributors go when verifying the regulatory compliance of products before making them available on the market?
The ruling provides welcome legal certainty and is likely to have an impact far beyond the specific case.
Background of the case
The proceedings concerned oil-free compressed air systems used in dental treatment environments.
The products were marketed with a CE marking and accompanied by an EU declaration of conformity. However, the declaration referred to machinery legislation, while indications existed that the products might qualify as accessories to medical devices under the MDR. A competitor challenged the distribution of the products and argued that the distributor had failed to fulfil its obligations under Article 14 MDR.
The German Federal Court of Justice referred several questions to the CJEU concerning the scope of a distributor’s verification obligations.
The key question
Article 14 MDR requires distributors to act with due care and to verify, before making a device available on the market, that:
- the CE marking has been affixed;
- an EU declaration of conformity has been drawn up; and
- certain other MDR requirements have been fulfilled.
The practical challenge has always been determining whether distributors merely need to check that the required documents exist or whether they must independently assess the correctness of the manufacturer’s regulatory classification and conformity assessment.
The CJEU’s answer
The Court adopted a balanced approach.
On the one hand, distributors are not required to repeat the manufacturer’s conformity assessment or conduct their own regulatory classification exercise. The responsibility for determining whether a product qualifies as a medical device and for conducting the appropriate conformity assessment remains primarily with the manufacturer.
On the other hand, distributors cannot simply ignore obvious inconsistencies.
The Court held that distributors must verify the consistency of the available documentation and information. This includes reviewing documents such as the declaration of conformity, instructions for use, information on the manufacturer’s website and marketing materials.
Where these sources clearly indicate that a product falls within the scope of the MDR, distributors should be able to identify obvious discrepancies, such as a declaration of conformity referring exclusively to legislation that does not appear to correspond with the product’s intended medical purpose.
No obligation to determine the correct risk class
Importantly, however, the Court also clarified that distributors are generally not required to verify whether a product has been assigned to the correct MDR risk class. The classification of a device remains the responsibility of the manufacturer and forms part of the conformity assessment process that distributors are not expected to duplicate.
Nevertheless, where the information available to the distributor indicates that the device falls within a risk class requiring the involvement of a notified body, the distributor must verify that the four-digit identification number of the notified body appears alongside the CE marking.
Why the judgment matters
The decision is significant because it clarifies the practical boundaries of distributor responsibility under the MDR.
Many distributors have been concerned that the broad wording of Article 14 MDR could effectively force them to conduct independent regulatory reviews of every product they distribute. Such an interpretation would have created substantial compliance burdens and blurred the distinction between the responsibilities of manufacturers and distributors.
The CJEU has now confirmed that this is not the case. At the same time, the judgment emphasises that distributors cannot rely solely on formal document checks. Obvious inconsistencies must be identified and addressed.
What happens if a competitor raises concerns?
An important practical aspect not expressly addressed by the CJEU is how distributors should react when they receive a formal notice, warning letter or cease-and-desist demand from a competitor alleging MDR non-compliance. Following the Court’s reasoning, distributors will likely find it more difficult to rely solely on the existence of a CE mark or a declaration of conformity once concrete concerns have been brought to their attention.
While the judgment does not specifically address competitor challenges, it is difficult to argue that a distributor can continue to rely exclusively on the manufacturer’s documentation once detailed and credible concerns have been raised.
Looking ahead: Possible impact of the proposed MDR reform
The judgment comes at a time when the European Commission is considering targeted amendments to the MDR. The Commission’s reform proposals published in late 2025 aim to reduce unnecessary regulatory burdens while improving the efficiency of the regulatory framework. Although the proposed amendments do not fundamentally alter the allocation of responsibilities between manufacturers and distributors, they reflect a broader policy objective of making MDR compliance more practical and proportionate.
At present, there is no indication that the proposed amendments would fundamentally change the verification obligations of distributors under Article 14 MDR. Against this background, the CJEU’s pragmatic approach appears consistent with the direction currently pursued by the Commission.
The judgment therefore provides timely guidance for distributors throughout the EU and is likely to become an important reference point for future MDR compliance assessments and enforcement activities.
