Guidance MDCG 2022-16 on Authorized Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2022-16 for authorized representatives, manufacturers, and other economic operators.

This document provides guidance for the identification and interpretation of requirements applicable to the various economic operators involved in placing on the market, making available on the market or putting into service devices where the registered office of the legal manufacturer is located outside the European Union.

The guidance states that the requirement for an authorized representative does not apply to devices intended for clinical investigations (MDR) or performance studies (IVDR).

DOWNLOAD THE GUIDANCE MDCG 2022-16