Where the manufacturer of a device is not established in a Member State, the device may only
be placed on the Union marketif 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.
This guidance document is written for authorised representatives, manufacturers and other economic operators, and intends to provide guidance on relevant requirements under the Regulations
For more information, read the document