According to the European Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, CE marked and properly registered devices in all 28 EU member states and 4 EFTA countries have free access to the EU market (according to Article 14 MDD 93/42/EEC as amended by the 2007/47/EC and Article 10 IVDD 98/79/EC). Thus, once your device is properly CE marked, it is allowed to circulate and be sold throughout the European Union.
However, the CE Marking only enables penetration to the European market and does not enable the device to be placed on other global markets.
Due to the high standards of health and safety required by the CE Marking, customers in non-EU countries request a Free Sales Certificate from the manufacturer to demonstrate the device meets the various safety and health requirements specified by the CE Marking.
The Certificate (Free Sales Certificate, FSC, Certificate of Marketability) will enable the device to penetrate the market of the relevant country and be freely sold to the public (presuming all local requirements are also met).
As the manufacturer is not within the european territory and cannot communicate with the authorities, this certificate can only be obtained through the manufacturer’s legal entity in Europe, the Authorized Representative.
In order to get the Free Sales Certificate for MDD and IVD devices, two conditions need to be met:
- The device must bear the CE Marking
- The manufacturer has appointed a European Authorized Representative for his device
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.
Polmed.de as your Authorized Representative may obtain a Free Sales Certificate for any non European country. The identification of the country is important because often the certificate of Marketability has been issued by the Authority and various different requirements are imposed by the country in regards to the legalization (apostille, translation, certification by the consulate etc.)