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.
- 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.
Further inquiry note
Page last modified: 04. November 2019