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EU Authorized Representative

The European Union requires all foreign firms wishing to market medical products in the EU to appoint an Authorized Representative (AR) to be responsible towards the European Government, representing the manufacturer in all European Regulatory Affairs. The AR will register the companies, which manufacture low-risk devices, with the Competent Authority in which the AR is located. The AR's address must appear on the product label, or the outer packaging, or instructions for use. MedicSense is affiliated to the most known professional ARs and can assist you in:

  • Allocating the appropriate AR that accommodate your needs
  • Make the contact with the AR
  • Supply the AR with all relevant company's regulatory information needed


 




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