The new EU MDR/IVDR regulations redefine the responsibilities of manufacturers, importers, and distributors—creating new risks for non-EU companies. This whitepaper explains why appointing your distributor as importer can expose you to compliance gaps, joint liability, channel conflicts, and loss of control. It explores the complications of working with multiple importers, including traceability issues, labeling challenges, and heightened audit demands. You’ll gain clarity on the legal definition of an importer, the key differences with distributors, and the potential risks to your business and reputation. Most importantly, the guide outlines the benefits of partnering with an independent, specialized EU-wide importer—ensuring compliance, safeguarding market access, and allowing distributors to focus on sales. With practical insights and expert guidance, this whitepaper equips you to make informed decisions and protect your business under the MDR/IVDR framework.
