Who Bears the Risk? EU Court of Justice Clarifies the Boundaries of Distributor and Manufacturer Obligations Under the EU Medical Devices Regulation

In summary, the CJEU’s decision clarifies that distributors must act with due care based on available information but are not responsible for technical classification or conformity assessments. Manufacturers retain full responsibility for correct classification and compliance with the EU Medical Devices Regulation. The judgment strikes a balanced approach, ensuring distributors are not overburdened whilst maintaining high standards for device safety and compliance, and it provides legal and commercial certainty for all economic operators in the medical device supply chain.

Facts and Background

The CJEU’s judgment in Case C‑10/24 Dürr Dental SE v Cattani Deutschland Helmes GmbH & Co. KG brings much needed clarity to the obligations of distributors under Regulation (EU) 2017/745 (Medical Devices Regulation, MDR), particularly where manufacturers may attempt to circumvent notified body involvement by misclassifying products.

The dispute arose when Dürr Dental, a manufacturer of dental compressors, challenged Cattani Deutschland, the German distributor for Cattani SpA, over the sale of oil-free dry air compressors for dental treatment. Dürr Dental contended that these compressors should be classified as medical devices (risk class IIa) under the Medical Device Regulation (MDR). However, they were instead certified for European Conformity (CE) solely as “machinery” under Directive 2006/42/EC. The products lacked the required four-digit notified body identification and an EU declaration of conformity as medical devices. Dürr Dental sought an injunction and damages, alleging Cattani Deutschland had failed to meet its distributor obligations under the MDR. Cattani Deutschland responded that its obligations applied only to products already classified and CE marked as medical devices by the manufacturer.

Applicable Law and Legal Principles

The CJEU focused on Article 14 of the MDR, which sets out the general obligations of distributors. Article 14(1) requires distributors to act with “due care” regarding applicable requirements when placing devices on the market. Article 14(2)(a) obliges distributors, before making a device available, to verify that it is CE marked and that an EU declaration of conformity has been drawn up. If a distributor considers or has reason to believe a device is non-compliant, Article 14(2) requires them not to make it available and to inform the manufacturer and, where relevant, authorities. Article 16 makes clear that distributors or importers only assume manufacturer obligations in specific cases, such as rebranding or modifying the device’s intended purpose. Article 51 places the responsibility for device classification firmly on the manufacturer.

The Court held that distributors must verify, based on accessible information, that the CE marking and EU declaration of conformity clearly relate to a medical device under the MDR. This obligation is limited to a practical “consistency check”—distributors are not required to independently determine or repeat the manufacturer’s classification or conformity assessment. If documents such as instructions for use, promotional materials, or the manufacturer’s website reveal a clear inconsistency (for example, if a product is obviously a medical device but only CE marked as machinery), the distributor must act. Distributors are not obliged to verify the risk class or the necessity for a notified body’s involvement unless it is clear from available information that such involvement is required. In those cases, the distributor must check for the notified body’s four-digit identification number.

The judgment also addresses situations where a distributor receives a formal notice—such as a letter from a competitor—alleging non-compliance. The distributor must consider this as part of its due care obligations and may need to seek clarification from the manufacturer or authorities. If, after enquiry, the manufacturer or a competent authority provides a reasoned, clear response that the product is compliant, the distributor can rely on this unless the response is manifestly unfounded. If the competent authority refutes the non-compliance, the distributor’s doubts are resolved.

The CJEU emphasised that the manufacturer bears primary responsibility for correct classification, conformity assessment, and CE marking. Distributors’ obligations are limited to what can reasonably be expected based on accessible information; they are not expected to have the technical expertise of manufacturers or notified bodies. The Court stressed that distributors are not required to act as regulatory experts and that their compliance burden, especially for Small and Medium sized Enterprises, is limited to reasonable vigilance and consistency checks. This approach supports legal certainty and clarity of roles within the supply chain.

Takeaways and Commercial Implications

This judgment reassures distributors that their obligations are confined to identifying obvious inconsistencies in CE marking and declarations of conformity—they are not required to conduct in-depth legal or technical assessments. Distributors who act with due care and rely on reasonable responses from manufacturers or authorities are protected from liability for non-compliance, unless they ignore manifestly obvious errors. For manufacturers, the decision makes clear that attempts to “downgrade” device classification to avoid notified body involvement are not shielded by the distributor’s limited obligations. Manufacturers remain fully responsible for proper classification and compliance with the MDR, and misclassification exposes them—not distributors—to regulatory and commercial risk.

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