Release of a new MDCG document
23 October 2022
In October 2022, the Medical Device Coordination Group has published the MDCG 2022-16 document “Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)”.
Where a 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 (Article 11(1) MDR and IVDR).
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.
This guidance document is written for authorised representatives, manufacturers, and other economic operators, and intends to provide guidance on relevant requirements under the Regulations.