Importers

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.

MDR/IVDR Article 13 describes many of the general obligations of importers. (For more information see also: ‘Blue Guide’ on the implementation of EU product rules.)

The importer is responsible for making sure that the devices they place on the market bear the CE marking, are accompanied by the required information and labelled in accordance with the Regulation, and have been assigned a UDI where applicable.

In addition, the importer should verify that devices are registered in EUDAMED.

If an importer considers that a device is not compliant with the Regulations, the device shall not be placed on the market and the importer shall inform the manufacturer and the authorised representative. The importer should also inform the authorities if they suspect that a device has been falsified or that there is a serious risk to health.

Importers should make sure that storage and transport conditions, when under their responsibility, do not jeopardise compliance.

Importers shall indicate on the device or 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.

Source: "Factsheet for Authorised Representatives, Importers and Distributors of medical devices and in vitro diagnostic medical devices."