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]

Following task needs to be performed by EU Importer

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

❖ 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.
• Verify importer name and address on the product or on its packaging or in a document accompanying the device.
• UDI assigned.

❖ If the importer deems the device does not comply with MDR, the device must not be placed on
the market.

❖ 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.