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…
Latest Regulatory Updates on Medical Devices: What You Need to Know to Stay Compliant The medical devices sector is constantly evolving, driven by both technological advancements and the regulatory complexity governing the market. Adding to the complexity is the fact that medical devices are sometimes subject to intersecting regulations, such as Regulation (EU) 2017/745 (MDR),…
MDR Transition Period Extension: FarmaImpresa Ensures Compliance for its Legacy Devices until 2028 The MDR (Medical Device Regulation), which came into force in May 2017 and has been applicable since May 2021, aims to create a robust and transparent regulatory framework for medical devices in Europe, ensuring safety and promoting innovation. However, because of concerns…