Switching Your German EC-REP: From Distributor to Independent Representative

This episode details the strategic process for medical device manufacturers to transition from a distributor-based EU Authorized Representative (EC-REP) to an independent one in Germany. We cover the regulatory requirements under MDR Article 12, the importance of the tripartite agreement, and the necessary steps for a smooth handover, including German database updates and labeling changes. • Why is using a distributor as an EC-REP a potential conflict of interest? • What is the first step in terminating an agreement with a distributor-representative? • What is a tripartite agreement and why is it essential for this change? • Which specific details must be included in the handover agreement? • How are post-market surveillance duties handled for devices already on the market? • Which German authority and database are involved in this process? • What are the practical implications for product labeling and packaging? • Do you need to inform your Notified Body about the change in EC-REP? • What are the key benefits of using an independent EC-REP? • How does an independent EC-REP better protect a manufacturer's intellectual property? 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.