Free Sale Certificate (EU)

A free sales certificate is required when selling medical devices in Europe. This document certifies that the product complies with the applicable requirements of the relevant legislation. It is issued by the competent authorities of the member states of the European Union.

Importance of Free sale certificate:

A free sales certificate is required for the importation of medical devices into the European Union.

– Medical devices must comply with the applicable requirements of national law. The free sale certificate is issued by the competent authority of each member state of the European Union. For more information about the specific requirements of each member state, please refer to the website of the competent authority.

– The free sales certificate is requested by an authorized representative of a manufacturer who is not located in the European Union.

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