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Importer means any natural or legal person established within the Union that places a device from a third country on the Union market;
The EU importers must verify that:
- Devices are CE marked, and the EU declaration of conformity is available a manufacturer is identified, and the manufacturer has designated an Authorised Representative;
- The device is labeled in accordance with the MDR and accompanied by the required instructions for use;
- UDI has been assigned;
- The device is registered in EUDAMED, and many MORE
BioReg can help you understand importer(s) obligations and how to define these responsibilities in the quality agreement properly.
Further, the EU importers must verify that:
- Indication of the importer’s name, registered trade name or registered trademark, their registered place of business and the address on the device or on its packaging or in a document accompanying the device
- Ensure that any additional label does not obscure any information on the label provided by the manufacturer.
- Ensure that storage or transport conditions do not jeopardize compliance with the general safety and performance requirements and comply with the conditions set by the manufacturer
- Keep a register of complaints of non-conforming devices and recalls and withdrawals, and provide the manufacturer, Authorised Representative and distributors with any information requested by them, to allow them to investigate complaints
- Keep a copy of the EU declaration of conformity and of any relevant certificate, including any amendments and supplements
- Cooperation with the Competent Authorities, including the provision of samples and granting access
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