Certificate of Free Sale (CFS)

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.

Comparison Table

EU MDR – Regulation (EU) 2017/745
EU IVDR – Regulation (EU) 2017/746
Article 60 / Certificate of free sale
Article 55 / Certificate of free sale

1. For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE marking in accordance with this Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 29. Where a notified body has issued a certificate pursuant to Article 56, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII.

For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE-marking in accordance with this Regulation may be marketed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 26. Where a notified body has issued a certificate pursuant to Article 51, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII.

2. The Commission may, by means of implementing acts, establish a model for certificates of free sale, taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).

2. The Commission may, by means of implementing acts, establish a model for certificates of free sale, taking into account international practice as regards the use of certificates of free sale. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2).

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