Medical Device Consulting: Authorized Representative in the European Union.

I3CGLOBAL makes the EUROPEAN AUTHORIZED REPRESENTATIVE service for medical devices available to its non-EU customers.

All medical devices (including active and in vitro) manufactured outside the European Union must have an authorized representative in the European Union based in any member state who must be appointed by the medical device manufacturing company in writing.

This representative must carry out the obligations contained in the European regulations on medical devices, Directive 93/42/EEC on medical devices and Regulation 2017/745 on medical devices. The EU authorized representative must be communicated to the authorities at the time of notification of placing on the market of class IIa, IIb and III medical devices.

This company responsible for medical devices marketed in the European Union must act as an interlocutor for the community health authorities and have at their disposal all the information related to imported medical devices at the headquarters communicated in a member state. One of the functions that they must carry out is the management and organization of claims and surveillance actions of medical devices placed on the Post Market Clinical Follow Up of which the company is a representative.

Within the service include:

  • Headquarters and postal service in the European Union.
  • Management and establishment of surveillance procedures.
  • Evaluation and adequacy of technical file and labeling.
  • Management of CE Marking for Medical Devices and declarations of conformity.
  • Dialogue with health administrations and notified bodies.
  • Communication of placing on the market of medical devices.
  • Documentary file management.
  • Supervision and training of distributors.

Contact us if you would like us to provide you with an adequate budget for the needs of your company to perform the functions of Authorized Representative in the European Union for your products.

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