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Foreign Medical Device manufacturers who do not have a physical location in Europe must appoint a European Authorized Representative (also referred as EAR) based in any member countries of the European Union, who are a part of the countries recognizing CE mark.
An European Union Authorized Representative serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with EU MDR (2017/745) and/or IVDR (2017/746). They act as a point of contact between the non-EU manufacturer and the notified body, as well as national competent authorities.
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