This episode explores the critical need for non-EU medical device manufacturers to replace their distributor-based EU Authorized Representative (EC-REP) with an independent one, particularly for the Spanish market. We delve into the increased liabilities for EC-REPs under the EU MDR (Regulation (EU) 2017/745), the inherent conflicts of interest when a distributor holds this role, and the clear benefits of partnering with a neutral, compliance-focused representative. Learn the official step-by-step process for making this crucial transition to secure your market access and protect your intellectual property.

Key Questions:

• Why is using your Spanish distributor as your EU Authorized Representative a major risk under the new MDR?

• What specific liabilities does your EC-REP now share with you for defective devices?

• How does an independent representative protect your confidential technical documentation from competitors?

• What is the official process for changing your EC-REP in Spain?

• How does the tripartite agreement work between the manufacturer, the old rep, and the new one?

• What are the critical labeling changes you must make when you switch representatives?

• Could a conflict of interest with your distributor-rep jeopardize your market access?

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.