MDR Importer Obligations — GrowthImports According to the Blue Guide / MDR the definition of the Importer is "Any natural or legal person established within the Union that places a device from a third country on the Union market”. A product is placed on the market when it is made available for the first time on the Union market. The Blue Guide makes clear that only manufacturers and importers can place devices on the market. We provide European wide independent MDR/IVDR compliant importing services for non-EU medical device manufacturers. You can choose to be your own IOR by placing your label on the product and comply with the importing requirements of the MDR/IVDR. #mdrimporter #IVDRimporter #MDRArticle13 Visit link for more detail https://www.growthimports.eu/article-13-mdrivdr