Obligations of medical device (MD) distributors: clarification of their scope before the CJEU

On September 11, 2025, the Advocate General of the Court of Justice of the European Union ("CJEU") delivered his opinion in a case concerning the placing on the market of oil-free dry air compressors, and clarified the extent of the distributor's obligations.

The questions asked were as follows:

• Is a distributor obliged to check whether the device it makes available on the market is to be considered a DM, and thus whether it complies with regulatory provisions?
• Do the distributor's verification obligations also involve checking whether the device must be classified in risk class IIa and, consequently, whether it must also bear a four-digit identification number from a notified body?

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Distributors' obligations with regard to medical devices

As a reminder, Regulation 2017/745 on medical devices ("MDR") defines the obligations incumbent on the various economic operators, and in particular distributors.

Article 14 of the RDM lays down a number of obligations to guarantee the conformity, safety and traceability of devices made available on the market, under which the distributor must check that :

• the device bears the CE mark and that the device's EU declaration of conformity has been drawn up.
• the device is accompanied by the documentation required by the manufacturer.
• the importer has complied with the applicable requirements.
• the manufacturer has assigned a UDI where applicable.
• communication between the various players is established in the event of non-conformity of the medical device.
• in the event of a non-compliant medical device, we work together to bring it into line.

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Clarifying the scope of distributor obligations 

General duty of care

The Advocate General's conclusions provide a number of clarifications on the obligations incumbent on distributors, and more specifically those relating to conformity control of the DM they make available on the market.

While Article 14 requires the distributor toact with due diligence in order to comply with the applicable requirements, the Advocate General here clarifies what is meant by "due diligence".

Please note: Diligence is "the effort made by an ordinarily prudent or reasonable party to avoid harm to the other party, given the circumstances." (Part 3.4 of the Blue Guide to the implementation of EU Product Regulation 2022).

Verification of DM qualification

Thus, as part of his duty of care, the distributor is required to check, in the light of the information available to him (basic knowledge expected of a DM distributor, content of the documents available to him, technical difficulty of the case in question), whether the CE marking and the EU declaration of conformity, relating to the product he is making available on the market, "obviously" relate to a device covered by this regulation. In this case, the obligation only applies to products for which it is clear, on the basis of the information available to the distributor, that they are DM or devices covered by the annexes to the regulation.

Point of attention linked to this new clarification: Before the device is made available on the market, the distributor must alert the relevant operators if he is aware of a problem with regard to the device's compliance with Regulation 2017/745 on medical devices (DM), justifying intervention in the event of incorrect qualification by the manufacturer.

Example: This erroneous qualification by the manufacturer would lead him, for example, to supply a CE marking and a declaration of conformity to Directive 2006/42/EC of the European Parliament and of the Council on machinery alone, whereas the device would in fact be a medical device subject to the RDM. In this respect, the Advocate General points out that the 2006 Machinery Directive applies only to machinery that is not covered by another directive or a more specific EU regulation (art. 3). Thus, in the presence of what would clearly appear to be a DM, Regulation 2017/745 on medical devices must be applied. The documentation provided must therefore attest to compliance with the MDR and the Machinery Directive where applicable.

Verification of the presence of the notified body's identification number

The distributor's obligations do not require them to check the manufacturer's classification, and in particular whether the device should be classified as IIa. This is easily explained by the technical nature of the classification operation.

However, if it appears from the information supplied that the device is classified by the manufacturer in a risk class necessarily involving the intervention of a notified body (class IIa, IIb, III), the distributor's duty of care may involve checking that the identification number of this body is indicated.

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These clarifications are important for distributors, in that they specify the scope of their obligations and define what may be expected of them in terms of conformity checks on the devices they make available on the market.

To be continued...

The CJEU is expected to issue its ruling in the coming months, possibly endorsing these clarifications of the distributor's obligations.

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