Certificate of free sale

Certificate of free sale

For the export of CE-marked medical devices and in vitro diagnostic medical devices outside Community market a certificate of free sale may be required.

Please note:

  • Certifcate of free sale are issued solely for medical devices or in vitro diagnostic medical devices
  • To export medical devices outside the Community market you may need a certificate of free sale (Check with the destination country to find out if you need a certificate of free sale).
  • Manufacturer or European authorised representative legally based in Austria may apply for a certificate of free sale.
  • Within the Community market CE-marked medical devices or in vitro diagnostic medical devices may be marketed without a confirmation of a competent authority. Therefore no certificate of free sale can be issued.
  • The medical devices and In-vitro diagnostic medical devices must fulfil the legal requirements and they have to be CE marked.
  • Copies of already issued certificates of free sale are not possible, a new application is necessary.

Application

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