Importers

Importers are responsible for verifying, prior to the import, that:

• the device has been CE marked and that the EU declaration of conformity of the device has been drawn up
• a manufacturer has been identified and that an authorised representative has been designated by the manufacturer
• the devices are labelled in accordance with the Regulation and accompanied by the required instructions for use
• a UDI has been assigned for the devices (if required for the devices concerned)
• the devices have been registered in EUDAMED (see also Why is an actor or device not found in the public Eudamed register?)

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.

Importers of medical devices must report their operator information to Eudamed and link the manufacturers in Eudamed whose devices they manufacture. If a device manufacturer is not found in Eudamed, the manufacturer and the devices must be linked using an Excel form. More information, see Device registration.