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CJEU Ruling Clarifies Scope Of Medical Device Definition
The Court of Justice of the European Union has issued a preliminary ruling in Case C-427/24 Diagramm Halbach, establishing critical principles for determining whether products qualify as medical devices under the EU Medical Device Regulation. The judgment clarifies that manufacturer advertising alone does not determine medical device status, and that products must objectively perform medical purposes to fall within the regulatory definition.
Arnold & Porter