Medical Devices: The CJEU Clarifies the Scope of a Distributor’s Duty of Care

CJEU, First Chamber, June 4, 2026, Case C‑10/24, Dürr Dental

Facts and Proceedings

The dispute before the German courts involves two operators in the market for dry air compressors intended for the production of compressed air for dental treatment. The manufacturer, Dürr Dental—whose own compressors are classified as Class IIa medical devices pursuant to a decision by the competent German authority (hereinafter “BfArM”)—conducted mystery shopping tests on competing compressors distributed in Germany by Cattani Deutschland.

These products bore a CE marking, but the EU declaration of conformity issued by the Italian manufacturer referred exclusively to Directive 2006/42 on machinery, and not to the regulations governing medical devices. Nor did they bear the four-digit identification number of any notified body, which is required for Class IIa devices.

Believing that these compressors constituted accessories to medical devices subject to the Medical Devices Regulation (MDR), Dürr Dental issued a formal notice to the distributor and then filed an action for injunctive relief based on German unfair competition law.

The distributor, for its part, had consulted the manufacturer, who confirmed that the product was not a medical device, as well as the BfArM, which had determined that no regulatory action was necessary and that the product could remain on the market.

The German Federal Court, to which the case was ultimately referred, has referred a question to the CJEU regarding the interpretation of Article 14(1) and Article 14(2)(a) and (3) of the MDR: Is the distributor required to verify whether the product it makes available on the market qualifies as a medical device, as well as its risk class? Furthermore, the issue was to determine the consequences of a formal notice issued by a competitor.

An obligation to “verify consistency,” limited to manifest errors

The Court first notes that the text of Article 14(2), first subparagraph, subparagraph (a), of the MDR requires the distributor to verify the presence of the CE marking and the EU Declaration of Conformity, but not their accuracy. Responsibility for the conformity of the device, including its classification, lies in principle with the manufacturer, who alone possesses precise knowledge of the product’s design, operation, and intended use (Articles 10 and 19 of the Medical Devices Regulation).

The Court therefore refuses to require the distributor to systematically repeat the conformity assessment carried out by the manufacturer. It holds, however, that the duty of care under Article 14(1), read in conjunction with the third subparagraph of paragraph 2, requires the distributor, prior to making the product available on the market, to exercise due diligence by conducting a “consistency check” based on the documents at its disposal or readily accessible to it: the EU Declaration of Conformity, the CE marking, instructions for use, as well as the manufacturer’s website or promotional materials. Thus, when a product clearly intended for medical use bears a CE marking issued solely under the Machinery Directive, the EU Declaration of Conformity must make it possible to detect a manifest inconsistency.

The Court precisely defines the standard of liability: a breach of the duty of care should only be found when the error in classification is manifest.

It will be up to the national court to assess whether the distributor’s efforts were sufficient in light of the basic knowledge expected of a distributor of medical devices, the content of the available documents, and the technical complexity of the specific case.

No obligation to verify the classification, subject only to formal verification of the notified body’s number

With regard to the risk class, the Court holds that the distributor is not required to verify whether the device should be classified as Class IIa.

Classification is the responsibility of the manufacturer (Articles 51–53 of the Medical Device Regulation) and, where applicable, the notified body, whose involvement attests to the complexity of the process; in the event of a disagreement, the dispute is resolved by the competent authority of the Member State where the manufacturer is headquartered, a decision that the distributor cannot challenge.

Extending the distributor’s obligation to this extent would blur the division of obligations among economic operators intended by the legislature and could even undermine the objective of protecting public health.

The Court, however, makes an exception in one scenario: when the information available to the distributor indicates that the manufacturer itself has classified the device into a class requiring the involvement of a notified body (Classes IIa, IIb, or III), the duty of care includes formally verifying the presence of that body’s four-digit identification number following the CE marking (Art. 20, § 5, MDR) .

Formal Notice from a Competitor: A Warning to Be Taken Seriously, but the Existence of Exculpatory Due Diligence

Finally, the Court ruled that a formal notice sent by a competitor, setting forth the factual and legal grounds for alleged non-conformity, may provide the distributor with “reasons to believe” that the product is non-compliant, within the meaning of Article 14, paragraph 2, third subparagraph, of the MD, and must be taken into account in fulfilling the distributor’s duty of care.

A distributor who then contacts the manufacturer may, however, rely on the manufacturer’s statement refuting the alleged non-compliance, without being held liable for a breach of its obligations, unless that statement appears manifestly unfounded. Above all, where the distributor has informed the competent national authority, that authority’s clear and reasoned opinion refuting the nonconformity “unreservedly” dispels the doubts expressed. The Court notes in passing that the steps taken by the distributor—such as consulting with the manufacturer and the authority—may enable the distributor to demonstrate before the national court that it has fulfilled its obligations.

Scope of the Judgment

This judgment provides distributors of medical devices with a practical framework for understanding their obligations under Article 14 of the MDR.

It requires them to conduct, prior to making the device available, a documentary consistency check covering the CE marking, the EU Declaration of Conformity, and the intended use of the product as set forth in the instructions for use and the manufacturer’s communication, as well as a formal check of the notified body’s number whenever the claimed class so requires.

In return, it offers them a form of legal certainty: the standard applied is that of manifest inconsistency, and the traceability of the due diligence performed with the manufacturer and the authorities constitutes a decisive exculpatory factor.

For manufacturers, the ruling reiterates that the responsibility for product classification and categorization rests entirely with them, including in the event of an erroneous classification of a product as a “machine” when it actually falls under the Medical Device Regulation (MDR) as a medical device accessory, since Directive 2006/42 yields to the lex specialis constituted by the regulation.

Finally, the ruling confirms the strategic importance of formal notices between competitors: while it does not in and of itself create an obligation to recall, it triggers the distributor’s obligation to respond and presents the distributor with a well-documented choice for which it will be held accountable.