Latest / Medical Device Global Market Access
Spain MedTech Compliance: Ditching Your Distributor for an Independent EC-REP
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…
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