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 companie...

Every step of medical devices logistics importing, selling, and marketing in the EU involves stringent regulations. The industry was once governed by the Medical Device Directive (MDD), eventually amended by the current Medical Devices Regulation (MDR).

GrowthImports is an independent European wide MDR compliant importer that provides hassle-free, cost-effective importing services while allowing clients to maintain full control and flexibility.

Under the old medical device directives (MDD 93/42/EEC), the requirement for a distributor is not mentioned, while the word importer appears three times.

It is the responsibility of manufacturers to ensure that their products bear the CE mark. Obtaining such certification requires implementing risk analyses and complying with regulations, and proving that they have done so.

All medical devices sold in the region are required to have Unique Device Identification (UDI) numbers under the MDR.

This post discusses the basics of the European Union (EU) Medical Device Regulation (MDR) and In Vitro Device (IVD), which took effect on 26 May 2021. All medical device manufacturers, importers, and repackagers that operate in Europe need to comply with...

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...