The Certificate of Free Sale under the MDR and the IVDR (Art. 60/55)

Article 60 MDR and Article 55 IVDR have the same requirements.

They are both related to the certificate of free sale. Certificate of free sale (also called something export certificate, free trade certificate or free sales certificate) is evidence that goods, such as medical devices, are legally sold or distributed in the open market, freely without restriction, and approved by the regulatory authorities in the country of origin. This document is essential for exporting manufacturers.

If a European manufacturer wants to market its medical devices in the Europe, it must demonstrate in a conformity assessment procedure that its devices meet the basic requirements established by EU regulations (MDR or IVDR). Certificate of free sale between EU countries are not needed.

If a European manufacturer wants to market its medical devices in the USA, it must demonstrate compliance with FDA requirements. Certificate of free sale is not accepted.

Nevertheless, a lot of countries recognize the CE marking and permit the marketing of medical devices that have, for example, already been approved for the European market. For those countries, the registration process of medical devices is simplified: For example, registration near local competent authorities only with an apostille copy of the Declaration of Conformity, an apostille copy of the Certificate of free sale, the labeling of the medical devices in local language or English.