25/07/2022 Other Services
Under the new MDR and IVDR, the EU representative fulfills important duties. The EC Rep acts as a legal interface between the manufacturer and the authorities of the European Union. The European Authorized Representative (E.A.R), located within Europe, must be named by manufacturers who lack a physical European location in Europe. It is required for CE Certification under Medical Device Regulation (MDR) 2017/745 and In Vitro-Diagnostic Medical Device (IVDR) 2017/746.
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