ECJ ruling on distributor obligations published
A European Court of Justice ruling clarifying distributor obligations under the Medical Device Regulation (MDR) has been officially published. The decision addresses due diligence requirements for CE marking and conformity declarations.
A ruling from the European Court of Justice (ECJ) in case C-10/24 was officially published in the Official Journal of the European Union on July 27, 2026. The decision specifies the inspection and due diligence obligations for distributors under Article 14 of the MDR.
The ruling clarifies the responsibilities of distributors concerning the CE marking, the declaration of conformity, and the identification of potential non-conformities. This aims to ensure that medical devices placed on the market meet all relevant EU safety and performance standards.
This development is significant for the medical device supply chain, as it provides a clearer framework for distributor accountability. It underlines the importance of proactive verification of product compliance by all parties involved in the distribution process.
The ECJ's decision seeks to enhance the safety of patients and users of medical devices within the European market by clearly defining the role and responsibilities of distributors in the oversight mechanism.