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 Blue Guide makes clear that only manufacturers and can place devices on the market.
Placing on the market is reserved either for a Export Medical Devices or an importer, i.e. the manufacturer and the importer are the only economic operators who place products on the market. When a manufacturer or an importer supplies a product to a distributor or an end-user for the first time, the operation is always labeled in legal terms as ‘placing on the market’. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available.
The whole goal of the changes of the economic operator in the MDR/IVDR is to have a separate entity in the supply chain for additional traceability. Competent authorities can act if they do not see this in the registrations.
