Many non-European countries request a personalized Free Sales Certificate from the manufacturer in order to place their device within a specific country.
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 27 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 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:
1. The device must bear the CE Marking
2. The manufacturer has appointed a European Authorized Representative for his device
• If the device(s) are CE marked, but not properly notified/registered with the European Authorities by the appointed European Authorized Representative (as required by Law for MDD Class I and IVD devices), the CE Marking is NOT valid and therefore the Free Sales Certificate cannot be issued.
To receive a Free Sales Certificate, you will be required to present your Authorized Representative with the following:
• Information about the device
• Name and form of the device
• Classification (according to EU regulation)
• Composition and description
• CE Certificate
• Information about the manufacturer
• Name and contact details
• Production Site
• Contact details for Notified Body
Please contact us at obelis.net for further details or to receive a Free Sales Certificate.