Latest / Medical Device Global Market Access
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…
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