TNMC Medical Devices

Your one stop regulatory assistants

TNMC Medical Devices UK and TNMC Devices Croatia acts as Authorized Representative for companies outside Europe who sells Medical Devices under the CE-Mark Rules

If your company does not have a physical location within the EU, European law for medical devices dictates that you must appoint a European Authorized Representative who is located within Europe to act as your liaison with the national Competent Authorities. TNMC Devices (Croatia) and TNMC Medical Devices UK is an official EU Authorized Representative for various medical device manufacturers worldwide, with offices located in Croatia and the United Kingdom.

What is the role of an EU Authorized Representative?

  • Acts as your primary contact point for all national Competent Authorities.
  • Registers your devices with the national Competent Authorities before they are marketed, where applicable.
  • Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
  • Gives you authorization to place our name and address on your device labels, packaging and Instructions for Use.Always available to interact between you and the national Competent Authorities.
  • Protects the confidentiality of your documentation.
  • Responsible for Incident reporting to Competent Authorities, in cooperation with you and your distributors.
  • Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.Notifies or is notified by, the Competent Authorities of serious device incidents.
  • The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.

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