CJEU clarifies MDR distributor due diligence: Dürr Dental (C 10/24)

On 4 June 2026, the Court of Justice of the European Union (CJEU) issued its judgment in Case C 10/24, Dürr Dental SE v Cattani Deutschland Helmes GmbH & Co. KG, providing important guidance on the scope of distributors’ obligations under Article 14 of the Medical Devices Regulation (MDR, Regulation (EU) 2017/745).

While similar reasoning may be applied by analogy to distributors of in vitro diagnostic medical devices, the judgment itself interprets the MDR only and does not expressly address the IVDR

Key findings

1. Background: compressors CE marked as “machinery”

Dürr Dental manufactures compressors for the production of compressed air for dental treatment. Following a decision of the German Federal Institute for Drugs and Medical Devices (BfArM), its compressors must be classified as class IIa medical devices under the former Medical Devices Directive.

Cattani Deutschland, the independent German representative of Italian manufacturer Cattani SpA, distributes “non‑lubricated” dry air compressors for dental treatment in Germany. In November 2020 and early 2021, Dürr Dental carried out two test purchases of such compressors: they bore a CE marking, but the EU declaration of conformity referred only to the Machinery Directive 2006/42/EC, with no reference to the medical devices legislation and no four‑digit notified body identification number, and they were supplied with instructions for use for “non‑lubricated dry air compressors 1‑2‑3 cylinders”

On the basis of the instructions for use and the manufacturer’s website, Dürr Dental considered the compressors to be accessories to class IIa medical devices that should have been CE‑marked under the medical devices regime and bear a notified body number, and sent Cattani Deutschland a cease‑and‑desist letter. Cattani refused, arguing that distributor obligations under the MDR applied only to products placed on the market as medical devices. It then sought confirmation from the Italian manufacturer, which stated that the compressors were not medical devices, and from BfArM, which considered that no official measures were necessary and that the devices could remain on the market as they were. Dürr Dental subsequently brought proceedings in Germany seeking an injunction and related relief, leading the Bundesgerichtshof (Federal Court of Justice) to refer questions to the CJEU on the interpretation of Article 14 MDR.

The CJEU’s answers clarify what a distributor must (and need not) do when a product’s status as a medical device, or its CE marking, is questionable.

2. Key findings on Article 14 MDR distributor obligations

2.1. No duty to re classify – but a mandatory “coherence check” and manifest errors

• Article 14(1) MDR requires distributors, when making devices available on the market, to “act with due care in relation to the requirements applicable”. Article 14(2) requires them, before placing a device on the market, to verify that it bears CE marking and that an EU declaration of conformity has been drawn up.
• The Court held that distributors are not required to verify the legal classification of each product or to repeat the manufacturer’s conformity assessment. Classification and full conformity assessment remain, in principle, the manufacturer’s responsibility.
• However, acting with “due care” and in light of the third subparagraph of Article 14(2), a distributor must carry out a “verification of consistency” (a coherence check), before making the product available, using the information and documents it has or can easily access (CE marking, EU declaration of conformity, instructions for use, manufacturer’s website and promotional material).
• In particular, the distributor must verify, in light of that information, whether the CE marking and the EU declaration of conformity clearly relate to a device falling within the MDR’s scope. If, for example, the product is obviously intended to be used with a dental unit in patient treatment (i.e. as a medical device or accessory), yet the CE marking and declaration of conformity refer only to the Machinery Directive, this inconsistency may indicate non conformity.
• A breach of the duty of due care arises only where the classification error is clear: infringement of the “coherence check” obligation can be found only when the classification error is obvious, and when the device is “manifestly” not compliant with the applicable regime. In such a case, the distributor has “reason to believe” that the device is not in conformity, must not make it available, and must inform the manufacturer (and, where applicable, the authorised representative and importer).42

2.2. Risk class and notified body number: limited checks

• The Court held that distributors are not obliged to verify whether a device should be in risk class IIa (or any particular class) under the MDR. They are not expected to re do the risk classification.
• However, if the information available to the distributor shows that the manufacturer has classified the device in a risk class that necessarily involves a notified body, then the distributor’s duty of due care includes checking that the four digit identification number of the notified body appears with the CE marking.

2.3. Competitor cease and desist letters and competent authority opinions

• The third subparagraph of Article 14(2) MDR requires a distributor that “considers or has reason to believe” a device is not in conformity not to make it available until it is brought into conformity and, where relevant, to inform the manufacturer, and to inform the competent authority if the device presents a serious risk or is falsified.
• A competitor’s formal notice / cease and desist letter which sets out reasons in fact and in law why the product is allegedly non compliant is relevant information for this assessment and must be taken into account, even if the device has already been made available.
• It is for the distributor to decide, under its own responsibility and applying due care, whether the letter gives it “reason to believe” that the device is not compliant and, if so, to take appropriate measures (including suspending supply and informing the manufacturer and, where appropriate, the competent authority).
• If the distributor consults the manufacturer and the competent authority, and the authority issues a reasoned and clear opinion refuting the alleged non compliance, that opinion is central to determining whether the distributor has complied with its due care obligations. The Court points out that steps such as those taken by Cattani Deutschland—contacting the manufacturer and BfArM—may demonstrate that the distributor has fulfilled its duty of care, depending on the circumstances.

3. Practical takeaways for EU medical device distributors

In light of Dürr Dental, distributors should review and refine their MDR compliance frameworks. In outline:

a) Build and document a “coherence check” into pre marketing procedures

• For each device, ensure that existing procedures explicitly cover:
  • verifying that CE marking is affixed and that an EU declaration of conformity exists;
  • checking that the legislation referenced in the CE marking / declaration is coherent with the product’s intended purpose as indicated in the instructions for use and promotional materials (i.e. MDR vs non medical legislation).
• Record the outcome of this check in a standardised form so that the distributor can demonstrate it has acted with due care.

b) Focus on obvious misclassifications, not re doing the manufacturer’s work

• Train staff not to re classify devices from scratch, but to identify clear inconsistencies, for example where a product is obviously used with a medical purpose in patient treatment but is CE marked solely under non medical legislation.
• Establish escalation criteria for “manifest” concerns and empower compliance or regulatory teams to suspend supply pending clarification from the manufacturer where such concerns arise.

c) Risk class and notified body number checks

• Do not attempt a detailed re assessment of the risk class. Instead:
  • where the documentation expressly indicates a risk class that requires notified body involvement, include a simple check that the four digit notified body ID is present next to the CE mark;
  • document any anomalies (e.g. notified body mentioned in documents but no number on the label) and seek clarification from the manufacturer before further distribution.

d) Handling compliance alerts

• Put in place a written SOP for handling external compliance alerts (including competitor cease and desist letters). The SOP should at least:
  • log the letter and its legal/factual allegations;
  • trigger a documented internal assessment of the alleged non compliance using the available MDR documentation and marketing materials;
  • require written consultation with the manufacturer, seeking a reasoned response;
  • consider, where appropriate, obtaining a view from the national competent authority and recording that opinion.
• Decisions to continue or suspend distribution after such a letter should be reasoned, documented, and clearly linked to the evidence (including any competent authority opinion).

e) Contracts, governance and training

• Review distribution agreements to:
  • confirm the manufacturer’s primary responsibility for classification and conformity assessment;
  • secure contractual rights to obtain up to date MDR documentation (including EU declarations of conformity and labelling) and to suspend supply where the distributor has reason to believe the device is non compliant.
• Train commercial and regulatory staff on the Article 14 due care standard and the practical meaning of a “coherence check” and “manifest” classification error.

The judgment confirms that distributors are not quasi notified bodies, but they cannot ignore obvious inconsistencies or credible external alerts. A proportionate, documented due diligence process around Article 14 MDR is now essential to managing compliance and litigation risk.