CERTIFICATE OF FREE SALE

 

MEDIACAL DEVICE CERTIFICATE OF FREE SALE

The CE mark is an indication to show conformity to all obligations for medical devices as required by the Medical Devices Directives. With the CE mark in place your products can be legally marketed in Europe.

However, for the penetration to non-EU markets a Free Sales Certificate must be provided by the manufacturer. The Free Sales Certificate demonstrates from the government that you place products, legally with the CE mark on the European market.

The European Free Sales Certificate (FSC) / Certificate of Marketability, is issued by the Competent Authority of the EU member state where the “manufacturer” in Europe or his authorized representative (EC REP) has his registered place of business. If the manufacturer is not situated in Europe only the Authorized Representative is able to obtain the Free Sales Certificate on behalf of the manufacturer.

In order to obtain a Free Sales Certificate / Certificate of Marketability for MDD and IVD devices the following information are needed: