What is an EAR?

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✿ A European Authorized Representative may also be known as Authorized Representative (AR)
✿ European Authorized Representative (EAR)
✿ EC REP
✿ CE REP
✿ EU REP
✿ EUAR
✿ All of these mean the same; EU Authorized Representative.
✿ as per the requirements from Article 11 of EU MDR 2017/745 and IVDR 2017/746.
✿ Where the 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 authorized representative.