By its judgment of 4 June 2026, the Court of Justice clarifies the verification obligations of distributors of medical devices under Article 14(1) and (2) MDR with regard to CE marking, the EU declaration of conformity and letters of formal notice from competitors.
The Bundesgerichtshof (Federal Court of Justice, Germany) referred five questions to the Court of Justice for a preliminary ruling on the obligations of distributors under Regulation (EU) 2017/745 on medical devices (MDR). The Court’s judgment of 4 June 2026 in Case C‑10/24 provides legal clarity for distributors and is likely to influence the interpretation of distributor obligations under other Union harmonisation legislation in the field of product safety law.
Background to the court proceedings
The proceedings before the Court concerned oil-free dry air compressors for the production of compressed air for dental treatment. According to the instructions for use and the manufacturer’s website, the compressors were accessories for a risk class IIa medical device. The manufacturer had affixed a CE marking to the compressors and drawn up an EU declaration of conformity that referred exclusively to Directive 2006/42 on machinery. In addition, the CE marking was not followed by the four-digit identification number of the notified body responsible for the conformity assessment procedure, although such a number is required for accessories to risk class IIa medical devices. The issue came to light through test purchases by a competitor, which subsequently sent the distributor a letter of formal notice.
Clarification of the obligation to verify the CE marking and the EU declaration of conformity
Under Article 14(1) and (2) MDR, distributors must, when making a device available on the market, act with due care in relation to the requirements applicable. Before making a device available on the market, they must verify, among other things, that the device has been CE marked and that the EU declaration of conformity of the device has been drawn up. However, these obligations do not amount to a comprehensive verification duty. According to the Court, a distributor must verify, in the light of the information at its disposal, whether the CE marking and the EU declaration of conformity for the product that it makes available on the market clearly concern a device falling within the scope of Regulation 2017/745.
This means that distributors of medical devices are generally required to check whether the EU declaration of conformity refers to compliance with the MDR where the information available to them — such as the instructions for use or the manufacturer’s website in the case before the Court — indicates that the product is a medical device or an accessory for a medical device.
No obligation to verify the risk class of the medical device
The same applies to the classification of the device in a risk class: determining the risk class is the manufacturer’s responsibility. According to the Court, a distributor is not obliged to verify whether the device the distributor makes available on the market must be classified in risk class IIa within the meaning of the MDR. However, where the information available to the distributor indicates that the device is classified by the manufacturer in a risk class necessarily entailing the involvement of a notified body — for example in the instructions for use or on the manufacturer’s website — the distributor’s obligation to act with due care includes verifying that the four-digit identification number of that notified body is indicated next to the CE marking. Such an identification number is required for medical devices in classes IIa, IIb and III and, in certain cases, class I devices.
Reason to believe that a device is not in conformity following a letter of formal notice
As part of their obligation to act with due care, distributors must also take into account letters of formal notice from competitors concerning the non-compliance of a medical device where such letters set out the reasons in fact and in law why the product concerned is not in conformity with Regulation 2017/745. It remains for the distributor to assess, under its responsibility, whether the formal notice provides reasons to believe that the product at issue is not in conformity with the MDR.
If the distributor informs the manufacturer of the alleged non-compliance raised by the competitor and the manufacturer takes the view that the alleged non-compliance is unfounded, the distributor generally fulfils its obligations under Article 14 MDR by following the manufacturer’s opinion. This does not apply where that opinion appears to the distributor to be manifestly unfounded. In such a case, the distributor may breach its obligation to act with due care if it nevertheless makes the medical device available on the EU market.
By contrast, where the distributor informs the competent national authority of the alleged non-compliance and that authority refutes the allegation by means of a reasoned and clear opinion, the doubts expressed as to the conformity of the product concerned are dispelled without reservation. In that situation, the distributor may generally make the medical device available on the market while complying with its obligation to act with due care.
Implications for distributors of medical devices
Before making medical devices available on the market, distributors must therefore verify, on the basis of the information at their disposal, whether the EU declaration of conformity and the CE marking clearly concern a medical device. The same applies to the indication of the notified body’s identification number next to the CE marking where the available information points to risk class IIa, IIb or III or, in certain cases, class I. In addition, distributors must take account of competitors’ letters of formal notice concerning alleged non-compliance in order to ensure compliance with their obligation to act with due care under Article 14(1) MDR.
Conclusion
The CJEU judgement clarifies that manufacturers of medical devices remain primarily responsible for conformity assessment, CE marking and classification in a risk class. With regard to distributors, the CJEU requires a high level of vigilance before medical devices are made available on the market as part of their verification obligations. In order to comply with that obligation, distributors should — for example as part of a PCMS — systematically record the manufacturer’s information on the intended purpose of the product and its risk class, and check it for consistency with the EU declaration of conformity and the CE marking. Letters of formal notice from competitors should be documented and assessed by distributors and, where appropriate, communicated to the manufacturer or the competent authority before the medical device is further made available on the market.
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