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:
- Definitions
- Designation, mandate, termination of the mandate
- Registration and verification obligations
- Minimum tasks and responsibilities
- Liability
- Change of EAR
- Person Responsible for Regulatory Compliance (PRRC . . .
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