EU MDR Importer Support

  • An importer is defined as being any natural or legal person established in the EU that places a device from a third country on the EU market.

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    As per MDR Art. 13, In order to place a device on the market, importers shall verify that:

    (a)the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
    (b)a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
    (c)the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
    (d)where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.

    Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.

    Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31.

    Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.

    Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.

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