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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).