Authorized representation

Eurotrade in association with Consultants Europe offers a unique package of services which includes:

  • Maintenance and administration of Technical Files, which are obligatory in the CE marking procedures.
  • Representation and registered address in Europe.
  • Deal with all judicial procedures related to products.
  • Inquiries from distributors, agents, customers, inspection authorities in liaison with and on behalf of the client.
  • Technical and legal assistance in liability claims.

European medical devices directives require the appointment of an Authorized Representative. The label and/or the instructions for use and/or the outer packaging of a device must contain the name and address of the authorized Representative of the manufacturer or exporter established within the European Economic Area.

Eurotrade as your Authorized Representative must:

  • Represent the Manufacturer in case of withdrawal of a medical device by a Member State(s).
  • Represent the Manufacturer before the national Competent Authorities in the European Economic Area.
  • Be available at all times to interact between the manufacturer and the national Competent Authorities; Be informed by the Competent Authorities of any incident(s).
  • Be responsible for incident reporting before Competent Authorities, in close liaison with the Manufacturer and the distributors.
  • Notify the Competent Authorities which investigations are to be conducted with regard to the product.
  • Keep at disposal the critical evaluation report of all data for Competent Authorities.

Authorized Representation Services include:

  • Verification of the classification of the medical device(s), and carrying out of a CE end-control. This CE end-control includes an investigation of the device and technical documentation (technical file), labeling and packaging.
  • Use of Consultants Europe's name and registered address in Europe (label requirement); office, phone, fax, mail handling, etc.
  • Notification to the Competent Authorities of the CE Declaration of Conformity, with description of the concerned device and names and addresses of distributors established in the Community.
  • Notification of the Competent Authorities of any changes in the product.
  • Administration of the technical file; presentation of the file or parts of it to Competent Authorities, when approved by client.
  • Technical and legal representation, assistance, and reporting in case of incidents reported by users, distributors, or National Competent Authorities. Organisation and carrying out, with the Manufacturer, the Incident Reporting.
  • Carrying out of assessment and determination of the severity of incidents.
  • Representation before the European Commission and national Competent Authorities, in case of recall or risk of product or withdrawal from the market.
  • "Product Information Desk" regarding all inquiries. We welcome all inquiries and will be pleased to provide more detailed Information on our Authorized Representation services and contractual arrangements.