Guidance on EAR: obligations and responsibilities under the Regulations

In October 2022, the Medical Device Coordination Group (MDCG) published a new Guidance on obligations and responsibilities of the Authorised Representative. According to the Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR), when the manufacturer is not established in the EU, they must appoint a European Authorised Representative (EAR).

Specifically, the new MDCG Guidance addresses several points: