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European Authorized Representative

  • Why choose a European Authorized Representative? Can’t my distributor do the job?
    This would be fairly uncommon. The EA Rep provides a highly specialized service. He handles your registrations, technical douments and complaints. The EA Rep also has to represent your company infront of the Competent Authorities (comparable to the FDA). A distributer cannot offer all of these services and concentrate on sales and marketing at the same time. Ask yourself this question: Would you want to depend on your distributer to handle your confidential information, answer to the authorities and stay up to date in regulatory affairs?
  • Why do we have to appoint an Authorized Representative?
    It is legally required for Risk Class I devices. Furthermore it is a requirement of certifying agencies (Notified Bodies).