Obtaining a Free Sales Certificate
In order to obtain a Free Sales Certificate,
- The product must properly comply with the applicable EU Requirements (technical file/PIF, registration, testing, etc)
- The manufacturer must have appointed a European Authorised Representative/EU Responsible Person to ensure their continued compliance
As a result, a Free Sales Certificate can only be obtained on your behalf by your current Authorised Representative or EU Responsible Person.
Free Sales Certificates are most commonly requested by the following countries:
|Saudi Arabia||South Korea||Taiwan||Thailand|
|United Arab Emirates|
Free Sales Certificates for Medical Devices
According to the European Medical Device Directive 93/42/EEC for legacy devices 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. 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 legacy devices or MDR compliant devices 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
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
Obelis can not only support you in ensuring your EU Market entry but also in achieving global growth.