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EU Importer

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EU Importer

EU Importer

Importer is defined as any natural or legal person established within the European Union that places a device from a third country on the Union market. It is the importer’s duty to ensure that only MDR-compliant devices are placed on the market. Importer is an economic operator who places product on the EU Market.
Art 13 EU MDR

An Importer shall perform the following task specified in the agreement between itself and the manufacturer

To notify the manufacturer and authorised representative of any non-conformities.
To notify the appropriate authorities in the event of a serious risk or a falsified device.
The importer must be registered with EUDAMED
To verify the device registration in EUDAMED.
To ensure storage and transport conditions of the device compliance with GSPR and with the set conditions of the manufacturer.
Maintain Complaint(s) list.
Cooperate with the manufacturer, authorized representative, distributors, and competent authorities.
Notify the manufacturer and its authorised representative of any complaints.
Keep a copy of the EU declaration of conformity and relevant certificates, if applicable.
If the importer deems the device does not comply with MDR, the device must not be placed on the market.
Before placing the device on the market, the importer shall verify for each device:
  • Device has been CE marked.
  • EU Declaration of Conformity drawn up..
  • Manufacturer identified.
  • AR Designated by the manufacturer.
  • MDR-compliant labelling and IFU.
  • UDI assigned.
  • Verify importer name and address on the product or on its packaging or in a document accompanying the device.

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