Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised
representative. The term ‘device’ will be understood to include medical devices, accessories
for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical
devices, accessories for in vitro diagnostic medical devices and also, custom-made devices.
For manufacturers who are not established in the Union the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Article 11 of the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) outlines the obligations of and introduces enhanced responsibility for the authorised representative. References to ‘the Regulations’ should be understood to cover both the MDR and IVDR…
