July 1, 2026
This decision was expected, given that the Advocate General’s opinion had already provided important clarifications regarding the level of diligence expected of distributors. We had discussed these in a previous article devoted to the obligations of medical device distributors and the clarifications expected from the CJEU.
The Court essentially confirms this approach: the distributor must verify consistency based on the information available to it, but it is not responsible for taking the place of the manufacturer in assessing the product’s conformity, qualification, or classification.
The case concerned the distribution in Germany of oil-free dry air compressors intended to produce compressed air for dental procedures.
These compressors bore the CE marking, but the EU Declaration of Conformity issued by the manufacturer did not address the regulations applicable to medical devices. It referred solely to Directive 2006/42/EC on machinery.
However, according to competitor Dürr Dental, these compressors should have been classified as accessories to medical devices (“MD”) falling under Class IIa. They should therefore have complied with the Medical Devices Regulation (MDR), borne a CE marking in accordance with that regulation, and, where applicable, included the four-digit identification number of the competent notified body.
Dürr Dental thus accused the German distributor, Cattani Deutschland, of making these products available on the market without verifying that they fell within the scope of the Medical Devices Regulation and without ensuring that the applicable requirements for medical devices were met.
The German court primarily asked the CJEU about the exact scope of the distributor’s obligations under Article 14 of the MDR.
The questions focused, in particular, on the following points:
The Court first notes that Article 14 of the RDM requires distributors to exercise due diligence when making a device available on the market.
This obligation is not limited to a purely mechanical check to verify the existence of documents. It requires the distributor to verify, based on the information at its disposal or to which it has access, that the CE marking and the EU Declaration of Conformity clearly relate to a device covered by the Medical Devices Regulation.
The Court thus sets forth the following principle:
“Article 14, paragraph 1, and paragraph 2, first subparagraph, subparagraph (a), of Regulation 2017/745 must be interpreted to mean that, as part of its duty of care, a distributor is required to verify, based on the information available to it, whether the CE marking and the EU declaration of conformity relating to the product it makes available on the market clearly refer to a device covered by that regulation.”
This ruling confirms the analysis already outlined by the Advocate General: the distributor must be able to detect a clear inconsistency, for example when the manufacturer’s documentation or the instructions for use indicate an obvious medical purpose, whereas the EU Declaration of Conformity refers only to another set of regulations.
The CJEU specifies, in particular, that the EU declaration of conformity, the CE marking, the user manual, the manufacturer’s website, and promotional materials may constitute relevant factors in assessing whether the distributor has exercised due diligence.
This is one of the most significant contributions of the ruling.
The Court takes care to point out that , as a matter of principle, responsibility for the product’s compliance rests with the manufacturer, not the distributor.
The manufacturer is, in fact, the party with precise knowledge of the product’s design, operation, and intended use. The manufacturer is therefore in the best position to determine the applicable regulations, draw up the EU Declaration of Conformity, and affix the appropriate CE marking.
The CJEU expressly states that a distributor may be required to take action when it has reason to believe that a device does not comply with the relevant requirements, even if it is not responsible for the product’s compliance.
She goes on to clarify that Article 14 of the RDM cannot be interpreted as requiring the distributor to verify the classification of each product or to systematically repeat the conformity assessment conducted by the manufacturer.
In other words, the distributor is not required to repeat the manufacturer’s regulatory work. It is not responsible for verifying the device’s compliance, but rather for exercising reasonable diligence regarding any obvious inconsistencies that may emerge from the available information.
This distinction is essential in practice: the distributor has a duty of care, a duty to conduct formal verification, and a duty to ensure consistency, but does not have a general obligation to conduct a full regulatory audit of the product.
The Court was also asked whether the distributor was required to verify that a device should have been classified as Class IIa and, consequently, bear the four-digit number of a notified body.
The CJEU’s answer is clear: the distributor is not required to verify the accuracy of the classification made by the manufacturer.
The Court notes that the classification of a medical device requires a precise understanding of its design, operation, intended use, and inherent risks. This analysis is the responsibility of the manufacturer and may require the involvement of a notified body or the competent authority in the event of a disagreement.
The Court therefore holds that:
“A distributor is not required to verify whether the device it makes available on the market must be classified as Risk Class IIa within the meaning of this Regulation. However, if the information available to that distributor indicates that the manufacturer has classified the device in a risk class requiring the involvement of a notified body, the distributor’s duty of care includes verifying the presence of that body’s four-digit identification number.”
The nuance is important.
The distributor is not required to determine on its own whether the product falls under Class I, IIa, IIb, or III. However, if the manufacturer’s documentation already indicates that the device falls under a class requiring the involvement of a notified body, the distributor must verify that the CE marking is accompanied by that body’s identification number.
So, once again, this is a matter of formal verification and consistency, not a reclassification of the product.
The CJEU has finally ruled on the scope of a formal notice issued by a competitor.
The Court considers that such a formal notice may give the distributor reason to believe that the product does not comply with the RDM, provided that it sets forth the factual and legal grounds for the alleged noncompliance.
The distributor cannot, therefore, simply ignore this. It must take it into account in fulfilling its duty of care.
Nevertheless, the Court once again takes a balanced position. If the distributor consults the manufacturer and the manufacturer considers that the alleged nonconformity is unfounded, the distributor cannot be held liable for following that opinion, unless it appears to be manifestly unfounded.
The Court adds that, when the distributor refers the matter to the competent national authority and that authority clearly and substantively refutes the alleged nonconformity, the doubts expressed regarding the product’s conformity are dispelled.
The CJEU summarizes the solution as follows:
“A distributor may have reason to believe that a product does not comply with Regulation 2017/745 when a competitor has sent the distributor a formal notice regarding the product’s noncompliance. If the manufacturer, when questioned by the distributor, is of the opinion that the alleged non-compliance is unfounded, the distributor cannot be held liable for failing to fulfill its obligations under this provision by following the manufacturer’s advice, unless that advice appears to the distributor to be manifestly unfounded. Where the distributor has notified the competent national authority pursuant to that provision, the doubts thus expressed regarding the conformity of the product in question are unreservedly dispelled by that authority’s clear and reasoned opinion refuting the alleged nonconformity.”
This clarification is useful in practice, particularly in cases of competition litigation or when a market participant files a complaint.
The ruling provides important clarification for medical device distributors.
He confirms that they are not required to conduct a comprehensive regulatory analysis of the products they distribute, nor are they required to take the place of the manufacturer in assessing the device’s compliance, qualification, or classification.
However, they must be able to demonstrate that they exercised reasonable and documented due diligence.
The ruling thus calls on distributors to establish a formal internal verification process prior to placing products on the market, without, however, turning this verification into a full regulatory compliance audit.
The CJEU reaffirms a balanced position.
The distributor is not merely a passive intermediary: it must act with due diligence and identify obvious inconsistencies based on the documents and information at its disposal.
But it is not a secondary manufacturer either: it is not required to systematically reclassify products, verify the accuracy of their classification, or repeat the conformity assessment.
In summary:
This ruling therefore clarifies the distributor’s role, while reiterating that Article 14 of the Medical Device Regulation requires genuine and traceable vigilance throughout the medical device distribution chain.
