Importer of medical devices in Europe

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.

The European medical device (MD) market is estimated to be worth around €140 billion. It is the second biggest MD market in the world, covering 27.6% of the world market, behind only the United States. This should be encouraging to medical device companies to consider exporting their products to the European Union (EU). Medical devices logistics are divided into four classifications (Class I, Class IIa, Class IIb, and Class III) based on risk and intended use—the higher the risk, the higher the Class.

Import your medical goods Into Europe with our hassle-free market Importing service. With 30 years of experience, GrowthImports is an ISO 13485 certified MDR/IVDR importer of medical devices in the European market. GrowthImports is one of the best Importers of medical devices in Europe. We provide non-EU medical and in-vitro device manufacturers with independent European-wide importing services compliant with Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) requirements.