Importer means any natural or legal person established within the European Union that places a device from a third country on the EU market.
Importers are responsible for verifying, prior to the import, that:
- the devices have been CE marked;
- the devices are accompanied by the required information;
- the devices are labelled in accordance with the Regulation;
- a UDI has been assigned for the devices (if required for the devices concerned);
- the devices have been registered in EUDAMED.
In case an importer considers that a device is not in conformity with the requirements of the Regulations, the device shall not be placed on the market and the importer shall inform the manufacturer and the manufacturer’s authorised representative. The importer should also notify the authority if it suspects that the device is falsified or poses a serious risk to health.
Importers should ensure that, while a device is under their responsibility, storage or transport conditions shall not jeopardise its compliance.
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.
Importers also have the responsibility to inform manufacturers and their authorised representatives in the event of complaints. They should also keep a register of complaints, non-conforming devices, recalls and withdrawals, and escalate non-compliance to authorities if they suspect that a device has been falsified or that there is a serious risk to health.
Importers are also required to cooperate with authorities and provide samples or grant access to the devices.
MDR/IVDR Article 13 describes the general obligations of importers in more detail.