Under the EU’s MDR, an importer is any natural or legal person established within the Union that places a device from a third country on the Union market.
Many of the general obligations to which importers are subject are set out in Article 13 of the Medical Devices Regulation and/or the In-Vitro Diagnostics Regulation.
In order to introduce a product to the EU market, an importer must check that the product carries the CE mark, that it is accompanied by the required documentation, that it is marked in accordance with the relevant regulations, and that the product has been assigned a UDI where required.
The importer should also check that the product is registered in EUDAMED.
Any importer who believes that a product is not in compliance with regulations must inform the manufacturer and its representative of this view, and must not introduce the product concerned into the market. If the importer has reason to believe that the product is counterfeit, or that it carries a serious health risk, it must also inform the relevant authorities.
