EUROPEAN AUTHORIZED REPRESENTATIVE TO U.S. MANUFACTURERS

Medical device manufacturers, that do not have a subsidiary in the European Community (EC) must designate an Authorized Representative, who is established in the EC to perform certain duties in accordance with the EC medical device directives prior to placing their products on the market.
As experts in European regulatory affairs, the UK office of Shotwell & Carr (S&C) can provide all of the management services - tailored to the manufacturer’s current and future needs - necessary to fulfill the role of a European Authorized Representative.

The services that S&C provide are:

  • Register the manufacturer and its products with a European regulatory body (the Competent Authority).
  • Register S&C as the manufacturer’s Authorized Representative.
  • Assist European distributors with the completion of registration documentation to be provided to the regulatory authority in their own country.
  • Check product labeling content to ensure it meets European regulatory requirements and that it includes the name and address of the Authorized Representative.
  • Hold in safe keeping the Declaration of Conformity and Technical File/Design Dossier for each of the products being marketed in Europe and make them readily accessible to the regulatory authorities when requested.
  • Review information related to product incidents to ascertain whether an adverse incident report needs to be filed.  File any necessary reports with the regulatory authorities.
  • Liaison with distributors and the manufacturer regarding product incidents, advisory notices and product recalls.
  • Manage on behalf of the manufacturer the issue of advisory notices and the recall of products.
  • Represent the manufacturer in correspondence and discussions with the regulatory authorities.

If you would like more information regarding this service, please fill out this form and one of our agents will contact you.
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IN THE U.S.:
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IN THE U.K.:
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E-mail: bpearce@shotcarr.com