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The tricky business of drug/device classification in the EU

Ellen Gielen and Bart Essink discuss the implications of the long-awaited court ruling on borderline products.


On 3 October, the Court of Justice of the EU published its long-awaited ruling in the Laboratories Lyocentre case in relation to the classification of medical products. The CJEU ruled that a product can be classified as a medicinal product in one EU member state and as a medical device in another. The case is significant for manufacturers of medical devices and medicinal products although it does not provide further guidance on those products belonging to the “grey area” between medical devices and medicinal products. It confirms previous rulings of the CJEU that products can be classified differently in different member states.

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Portrait of Ellen Gielen
Ellen Gielen
Bart Essink