EU Medical Devices: Breaking Up with Your Distributor-AR in France

Medical Device Global Market Access · Oct 28, 2025 · 3m

This episode explores the critical shift for medical device manufacturers from using a distributor as their EU Authorized Representative (EC-REP) to appointing a professional, independent representative in France. We delve into the increased liabilities under the MDR, the inherent conflicts of interest in the distributor model, and the significant commercial and regulatory advantages of partnering with an independent AR for streamlined access to the French and broader EU markets. • Why is using a distributor as your EU Authorized Representative now considered a major risk? • What specific…