The MHRA published information this week reminding medical device companies doing business abroad that they should check if they need a certificate to export their medical devices.
To export to countries outside the EU, companies may require a Certificate of Free Sale (CFS). A certificate is not required to supply medical devices within the EU.
Certificates of Free Sale are used in the registration or renewal of the registration of medical devices in non-EU countries or to accompany a shipment of that device.
As a first step, you should check with the destination country to find out if a CFS is needed.
The manufacturer, legal manufacturer, Authorised Representative or distributor must be based in the UK and the medical devices to be exported must have both proof of manufacture and be CE marked. If a device isn’t CE marked for the purpose of being sold outside the EU, the manufacturer must prove that the device is equivalent to one that is CE marked.
If you require assistance with obtaining Certificates of Free Sale, please contact us at Regulis for assistance.