CJEU clarifies medical devices distributors due diligence obligations under MDR and IVDR

The Court of Justice (CJEU) clarified distributor obligations under Article 14 MDR (and IVDR) recently in the Dürr Dental case (C-10/24). Spoiler: it's not surprising but clarifying, with a dash of novelty.

The facts in brief. Cattani Deutschland distributed oil-free dental air compressors in Germany. The devices were CE marked — but as "machinery" under Directive 2006/42, not as medical devices under the MDR. Germany's BfArM had determined that precisely this type of compressor qualifies as a class IIa medical device accessory. Competitor Dürr Dental sent a cease-and-desist letter, Cattani consulted both its Italian manufacturer (who said: not a medical device) and BfArM (which declined to take enforcement action), and continued distributing.

The CJEU makes three points:

1) Distributors are not passive conduit pipes and must perform what the CJEU calls a "coherence check": verifying, based on documents in its possession (EU Declaration of Conformity, instructions for use, manufacturer website, promotional materials) whether the CE marking and DoC manifestly relate to a device falling under the MDR. A breach of the due diligence obligation can only be established where the qualification error is manifest. Systematically re-doing the manufacturer's own conformity assessment is not required.

2) Distributors are not obliged to verify whether a device should be classified as class IIa but if the manufacturer has classified the device in a class requiring notified body involvement the distributor's due diligence must include checking for the four-digit NB identification number.

3) A competitor's cease-and-desist letter can give the distributor "reason to believe" there is non-compliance under Article 14(2)(3) MDR. The distributor must take the letter seriously, assess it and check the manufacturer. The distributor cannot be blamed for following the manufacturer unless the manufacturer's view appears manifestly unjustified. And if the distributor has informed the national competent authority and that authority issues a clear, reasoned opinion rebutting non-compliance, the doubts are fully and definitively resolved.

Is this judgment surprising? Not fundamentally. But it is clarifying and shows how distributor procedures must be amended. The novelty is that when a distributor receives a cease-and-desist from a competitor, this triggers a documented due diligence process: consult the manufacturer in writing, and consider proactively engaging with the national competent authority. The practical problem in the latter case is that it takes some authorities very long to respond so they will need to up their game here too. In practice this will mean that distributors will mainly rely on checking with the manufacturer if they want a quick answer and can live with less than 100% certainty.