The Court of Justice of the European Union has clarified whether a health-related product counts as a “medical device” in the EU, which determines whether the heavy compliance obligations of the Medical Devices Regulation apply. In Case C-427/24, Diagramm Halbach, the Court held that the analysis has two parts: what the manufacturer says the product is for, drawn from labeling, instructions and marketing, and whether the product objectively performs one of the specific medical functions the regulation lists, such as diagnosis, monitoring, or treatment of disease. Marketing claims should not be considered in isolation and may not pull a product into the regime if it does not actually perform a medical function, and equally a company cannot avoid the rules by staying quiet about an obvious medical use. For founders building software or AI-enabled health tools, the ruling sharpens the line between administrative or organizational features and functions that genuinely inform clinical decisions, and that distinction determines whether CE marking and conformity assessment are required before selling in the EU.
