Latest / Medical Device Global Market Access
Unlocking Italy: The Distributor vs. Independent EU Rep Dilemma
This episode explores the critical shift for MedTech manufacturers from using distributors to appointing independent Authorized Representatives (EC-REPs) in Italy, driven by the EU's Medical Device Regulation (MDR). We unpack the increased legal liabilities, conflicts of interest, and commercial risks associated with the old model, and explain why an independent AR is now essential for secure and flexible market access. Key Questions: • Why is using your Italian distributor as your EU Authorized Representative a major risk under the new MDR? • What does "jointly and severally liable" mean for…
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