We as an EU importer under MDR Article 13 and IVDR Article 13 for non-EU manufacturers placing medical devices or IVD products on the European market. Our importer services support documentation checks, product traceability, labelling requirements, EUDAMED-related activities, and coordination with manufacturers, authorized representatives and distributors. The service is integrated with our warehousing, logistics and customer support capabilities, creating a practical operational framework for European market entry. This helps manufacturers connect regulatory responsibility with controlled physical distribution and establish a structured route into Europe.