Global medical device market regulators are asking manufacturers of medical devices to provide a Free Sales Certificate (FSC) what is showing that their devices are adequate CE marked and approved for sale in Europe. Your FSC must be presented to local authorities as part of your registration process. In many situations your FSC must have an apostille or must be legalized by the Ministry of Foreign Affairs and by the local Embassy
A FSC will be issued by the Dutch Competent Authority upon request by us as assigned Authorized Representative on behalf you as medical device manufacturer.
This according to the European Medical Device Regulations: Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC.
To get the FSC 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
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!
If we act as your EU Authorized Representative we need to receive the following information
- Description, intended use and risk classification of the device
- Name and type of the device
- Declaration of Conformity
- Valid CE Certificate and QMS Certificate
- Background information about the manufacturer
- Name and contact details
- Production Site
- 'Certicate of Insurance'
If we are not appointed as your Authorized Representative yet we'll support you to transfer your AR contract to MRM.
In many situations your FSC need to have also an Apostille, something what is included in our FSC serves.