European (EU) Authorized Representative

According to European law for medical devices, companies that do not have a physical location in the Europe must appoint a European Authorized Representative who is located within Europe. It is required for European Medical Devices Directives (Medical Device Directive 93/42/EEC; Active Implantable Medical Devices 90/385/EEC; and, In Vitro Diagnostic Medical Device Directive 98/79/EEC).
An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. After appointing European Representative he/she or there company will effectively ensure your company’s compliance with the European Regulatory reporting requirements as per the tasks required in the applicable directives.
The Authorized Representative performs certain duties under the European Medical Devices Directives and acts as a legal interface between the Medical Device manufacturer and the EU Authorities. EU/EC Authorized/Authorized Representative cannot modify the product on his own initiative in order to bring it into line with the applicable directives.

The Aspects of an Authorized Representative

  1. The Authorized Representative must be included on the product labeling (and/or) instructions for use (etc.).
  2. The Authorized Representative is responsible towards the European Government, representing the manufacturer in all European Regulatory Affairs.
  3. The Authorized Representative is obliged to submit Medical Device Reports (MDRs) on behalf of the manufacturer.
  4. The Authorized Representative must be appointed in writing (MOU) . All duties and responsibilities should be clearly defined and assigned.
  5. The Authorized Representative must at all times be available to interact between the manufacturer, the European Authorities and the notified body.

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