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 your European regulatory partner?

• How does the EU MDR create a conflict of interest for a distributor acting as your AR?

• Can your distributor legally hold your device registrations hostage if you want to switch partners?

• What are the strategic advantages of appointing an independent EC-REP for the Italian market?

• How does separating your regulatory and commercial partners improve your business flexibility?

• What is the primary role of an Authorized Representative in communicating with the Italian Ministry of Health?

• Does your current EU AR agreement protect you from the new liability clauses in Regulation (EU) 2017/745?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.