Website of the Department of Health

Certificates of Free Sale for CE-marked Medical Devices

Certificates of Free Sale (CFS) are issued free of charge by the Department of Health as a service to UK based exporters of CE-marked medical devices. CFS are NOT export licences; they are issued in response to requests from the authorities (customs etc.) of the importing country who are seeking declarations that the medical devices conform to the same quality and safety standards that apply in the United Kingdom and the rest of the European Union. They cover medical devices as defined by the Active Implant Directive; the Medical Devices Directive and the In-Vitro Diagnostic Devices Directive. Certificates of Free Sale are also issued for accessories associated with medical devices, if they are covered by the relevant legislation. There is no charge for this service