Medical devices: CJEU clarifies distributor obligations under the MDR

In a rare and highly anticipated judgment, the Court of Justice of the European Union (CJEU) has provided important guidance defining the precise scope of distributor's obligations under Article 14 of the Medical Device Regulation (EU) 2017/745 (MDR) and clarifying the allocation of responsibilities between distributors and manufacturers.

The case concerned dental care compressors that bore a CE "machinery" marking (Directive 2006/42), despite constituting accessories to a medical device falling within Regulation (EU) 2017/745.

The Court held that, as part of its duty of diligence, the distributor must carry out a simple "consistency check": verifying, on the basis of the information available to it, that the CE marking and the EU declaration of conformity clearly relate to a device falling within the scope of the MDR, without repeating the manufacturer's conformity assessment.

The distributor is not required to verify the accuracy of the risk classification, except to check for the presence of the four-digit identification number of the notified body where the information indicates a class requiring it.

Finally, a formal notice from a competitor may constitute "reasons to believe" that there is non-compliance; the manufacturer's contrary opinion releases the distributor from liability, unless it is manifestly unfounded, and a clear and reasoned opinion from the national authority dispels any doubts. Responsibility for conformity remains with the manufacturer.

Practical implications for medical device distributors under the MDR

Distributors should formalise a documented incoming consistency-check procedure covering the EU declaration, instructions for use, marking, notified body number, manufacturer's website and promotional materials, and retain evidence of their diligence, including exchanges with the manufacturer and the competent authority, which may be decisive in establishing a defence.

Manufacturer-distributor agreements should include clauses on conformity warranties, information obligations and cooperation in the event of a formal notice.

For litigation, the judgment provides a useful "case-by-case" assessment framework both for claimants and defendants, particularly in unfair competition and injunction proceedings.

Read the full judgement of the Court here.