CJEU Clarifies Borderline Medical Devices and Drugs

News, Regulatory

A crucial EU ruling (Case C-589/23) redefines the distinction between medical devices and medicinal products, clarifying when a substance—like D-mannose—exerts a pharmacological action under Directive 2001/83/EC The boundary between “medicinal product” and “medical device” is often subject to divergent interpretations in European markets, especially for so-called borderline products that do not clearly fall under one…