EU advocate general clarifies medical device classification and distributor duties

The Court of Justice of the European Union has received its first opportunity to interpret distributor obligations under the Medical Devices Regulation (EU) 2017/745 (MDR) in a case concerning oil-free dental compressors. Advocate general of the CJEU, Dean Spielmann, in his opinion delivered on 11 September in Case C-10/24 Dürr Dental SE v Cattani Deutschland, provided valuable guidance on the scope of verification duties required of medical device distributors and their responsibilities regarding product classification.

This preliminary ruling addresses fundamental questions about how distributors should verify device conformity before making products available on the market, particularly where manufacturers have applied different regulatory frameworks to their products.

Case origins

The dispute referred to the European Court arose between two German companies in the dental equipment sector. Dürr Dental SE, a manufacturer of compressors for dental treatment applications, challenged Cattani Deutschland Helmes GmbH & Co. KG's distribution of competing oil-free dry air compressors. The contested products were manufactured by Italian company Cattani S.p.A., with the German entity serving as its distributor.

According to a 2014 decision by Germany's Federal Institute for Drugs and Medical Devices, such compressors constitute risk class IIa medical devices under the EU medical device framework. However, Cattani's distributed products bore CE marking as machinery under Machinery Directive 2006/42/EC rather than as medical devices under the currently revised MDR framework. The devices therefore lacked the four-digit identification number of a notified body required for class IIa medical devices and were accompanied by declarations of conformity referencing machinery rather than medical device legislation.

Dürr Dental argued that these products should properly be classified as accessories for medical devices, requiring appropriate MDR-compliant CE marking and certification procedures. After test purchases and formal notices to Cattani proved unsuccessful, Dürr Dental sought injunctive relief through German courts to prevent distribution of improperly marked devices.

The German Federal Court of Justice ultimately referred five preliminary questions to the CJEU, focusing on distributors' verification obligations under article 14 of the MDR and the factors that should trigger enhanced scrutiny by distributors when assessing device conformity.

Product qualification guidance

The advocate general's opinion provides preliminary clarification on how EU law approaches product classification disputes, particularly where devices may fall under multiple regulatory frameworks. The case highlights the hierarchical relationship between EU legislation, with more specific regulations taking precedence over general ones.

Article 3 of the Machinery Directive establishes that machinery legislation does not apply where hazards are covered in whole or in part by other, more specific EU legislation. The opinion confirms that this creates a lex specialis relationship, with the MDR representing more specific legislation for medical applications compared to the general machinery framework. As the advocate general notes, the European Commission's Guide to application of the Machinery Directive explicitly recognises that medical device legislation addresses the hazards of machinery intended for medical use with greater specificity than the general machinery provisions.

This interpretation aligns with the broader regulatory approach established through the New Legislative Framework for the marketing of products (NLF), which has been recently revised to incorporate new products such as high-risk AI systems and other healthcare products such as electronic health records. The framework seeks to create coherent obligations across different product fields while recognising the need for sector-specific requirements, for example where public health considerations demand enhanced protection levels.

The opinion emphasises that manufacturers bear primary responsibility for correct product qualification, as they possess the most comprehensive knowledge of their products' design, operation and intended purpose.

MDR distributor obligations

The advocate general's analysis provides the first detailed interpretation of Article 14 of the MDR, which establishes general obligations for medical device distributors. This represents a significant development given the MDR's alignment with the NLF and its clarification of economic operator responsibilities.

The MDR establishes that distributors must act with due care when making devices available on the market. This encompasses specific verification duties that form the cornerstone of distributor responsibility. Before placing products in the supply chain, distributors must ensure devices bear the CE marking and are accompanied by EU declarations of conformity, carry required manufacturer information, meet any applicable importer requirements, and display UDI numbers where mandatory.

The advocate general's interpretation draws a crucial distinction between checking that documentation exists versus verifying its technical accuracy. Distributors must confirm the presence of conformity markings and declarations rather than conducting detailed technical assessments. This suggests that in-depth conformity evaluation requires manufacturer-level expertise and resources that distributors typically lack.

The opinion introduces an important qualification through the concept of due care obligations. Where distributors have reason to suspect non-compliance, they must refrain from making devices available on the market. This creates what the advocate general describes as a verification of consistency requirement based on information readily accessible to distributors during normal business operations.

The Commission's guidance interprets due care as the reasonable efforts expected from prudent operators to prevent harm, considering their particular circumstances. This standard requires distributors to develop sufficient knowledge to spot obvious non-compliance indicators while recognising their distinct role compared to manufacturers and notified bodies in the broader medical device ecosystem.

Interconnection with EU frameworks

The opinion demonstrates how the MDR's distributor obligations connect with broader EU product regulation principles established through the NLF. The regulation explicitly commits to establishing clear general obligations for different economic operators, including importers and distributors, while building upon the comprehensive EU framework for marketing products.

This alignment reflects lessons learned from the PIP (Poly Implant Prothèse) breast implant scandal, which highlighted gaps in oversight throughout medical device supply chains. With new MDR rules, the regulatory response sought to enhance transparency and accountability amongst all economic operators. Early in the adoption process, industry, regulators and notified bodies alike have criticised the regulations as unfit for purpose, prompting multiple reforms at EU level.

The relationship with machinery legislation illustrates how the NLF manages overlapping product categories. The Machinery Directive establishes clear hierarchical principles, preventing regulatory gaps whilst avoiding duplicative requirements. The advocate general notes that the forthcoming Machinery Regulation, applicable from January 2027, will explicitly include distributor obligations aligned with established framework principles, creating a more coherent regulatory landscape.

The opinion also addresses how conformity assessment procedures differ between product categories. While machinery generally permits manufacturer self-certification for many products, medical devices require independent notified body involvement for higher risk classes. This distinction reflects the elevated risk profile associated with medical applications and the corresponding need for independent verification of safety and performance claims.

Osborne Clarke comment

This landmark opinion provides essential guidance on distributor responsibilities under the MDR while maintaining appropriate boundaries between different economic operators' roles. The advocate general's approach balances patient safety objectives with practical recognition of distributors' position in the medical device supply chain.

The "verification of consistency" standard offers a workable framework for distributor due diligence that avoids imposing inappropriate technical assessment burdens whilst ensuring adequate oversight.

The emphasis on readily available information suggests that distributors should systematically examine declarations of conformity, product marking, instructions for use, and manufacturer websites for consistency indicators. Where products have medical applications but bear machinery CE marking, or where technical documentation references inappropriate regulatory frameworks, enhanced scrutiny would be prudent – if the opinion is eventually upheld by the court in its final ruling.

For manufacturers, the opinion reinforces the importance of accurate initial classification and clear communication with distribution partners. Providing distributors with appropriate guidance on product classification and regulatory requirements can help prevent market access disruptions whilst supporting compliance throughout the supply chain.

The pending CJEU judgment will establish binding precedent for national courts and regulatory authorities across the EU. While this opinion provides indication of the court's possible approach, businesses should monitor the final ruling expected in early 2026. Distributors may wish to review their verification procedures in light of the upcoming decision, particularly regarding documentation review processes and staff training on identifying obvious classification discrepancies.