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Free Sales Certificate

Selling products within the European Union must comply with the EU-regulations MDR and IVDR. Especially non-EU manufacturers are forced to appoint an EC-REP. A compliance with EU regulations allows EU and non-EU manufacturers to sell their medical products in many other countries of around the world. Therefore they need a a so called Free Sales Certificate that is issued by an EU competent azthority. MedNet helps you as manufacturer to gain access to other countries worldwide with a Representation within the EU and a Free Sales Certificate.

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EU-members

Manufacturers who want to apply for a Free Sales Certificate must comply with the EU regulations. We support you by offering following services:

  • Acting as your authorised representative
  • Check of your compliance with the EU Regulations for Medical Devices (MDR) and In-Vitro Diagnostic Devices (IVDR).
  • Collecting all necessary information for the FSC application and applying for the Free Sales Certificate
  • Providing manufacturers with the FSC manufacturers with the FSC ready to be used with non-EU competent authorities

As your Authorized Representative MedNet EC-REP supports EU-based manufacturers of IVD and medical devices to apply for a Free Sales Certificate and assists you with additional services.

non-EU members

Non-EU manufacturers are forced to appoint an European Authorized Representative to sell their products in the European Union.

To obtain a Free Sales Certificate these products have to adhere to EU regulations.

We offer a range of services to support non-EU manufacturers in this process, including:

  1. Serving as your European Authorized Representative
  2. Ensuring your compliance with EU Regulations for Medical Devices (MDR) and In-Vitro Diagnostic Devices (IVDR)
  3. Gathering all essential information required for the Free Sales Certificate application
  4. Managing the application for the Free Sales Certificate on your behalf
  5. Providing manufacturers with a fully prepared Free Sales Certificate that can be submitted to non-EU competent authorities

As your European Authorized Representative, MedNet EC-REP is dedicated to assisting non-EU-based manufacturers of IVD and medical devices in their pursuit of a Free Sales Certificate asd well as offering a range of supplementary services to facilitate the process.

Get a Quote

Our cross-cultural team of scientists and engineers is well equipped to understand your needs and the requirements your are going to face by bringing your device on the European, British or Swiss market.
Let us know your requirements and we will be at your service.