If you are a non-EU manufacturer of medical devices or In-Vitro Diagnostic devices you need to comply with the Medical Device Regulation (MDR). The Regulation states manufacturers have to assign an importer that will have to meet the requirements and will be liable and responsible for placing products on the EU market.
The new MDR and IVDR for Importers And Distributors
If you are a non-EU manufacturer of medical devices or In-Vitro Diagnostic devices you need to comply with the Medical Device Regulation (MDR). The Regulation states manufacturers have to assign an importer that will have to meet the requirements and will be liable and responsible for placing products on the EU market.
An Importer has different responsibilities from the other Economic Operators such as the Authorized Representative and Distributors. With GrowthImports you will comply with Article 13 and have an independent partner for your importing needs across Europe and the United Kingdom.
