According to the European Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, properly notified (if required) and CE marked medical devices are allowed to circulate and be sold throughout the European Union.
Non-EU Authorities may request a Certificate of Free Sales (FSC) from the manufacturer to confirm that:
1.The Device in question meets the safety & health requirements of the relevant Directive
2.As such, the Device is indeed CE marked!
3.As such, the Device is Free to Circulate in the EU Community
4.As such, the Device may be Free to Circulate in the Non-EU country requesting the FSC
As the CE marking is a European mark under a European Law, it is aimed at European entities only – as such, the following questions arise:
1.Who can issue a FSC?
2.Who can request a FSC?
3.What will be mentioned on the FSC?
The answers to these fundamental questions can be found hereunder:
A FSC for a CE marked device can only be issued by a European Authority (Ministry of Health in case of medical devices). If the manufacturer of the CE marked device is established outside of the European Union, only his appointed Authorized Representative (EC REP) may request it on his behalf. The FSC will eventually only re-confirm the information on the relevant CE certificate (nothing more!) and its basis the free circulation will be granted.
Important Notice: there is no need for a FSC in order to place devices in the EU market – the FSC is required by Non-European countries only (!)
Documentation Required (unless special provisions by different EU states):
1.CE (EC) certificate
2.EC Design examination certificate (class III of MDD)
3.ISO certificate (ISO 9001 and/or ISO 13485 certificates)
4.EC Declaration of conformity (duly signed, dated and stamped)
5.EC REP Designation letter
None the less, it is crucial to remember that before any documentation is provided, the proper classification of a device needs to be confirmed as it is the basis to all matters under European regulation – in order to classify devices or only to confirm their classification the following is needed:
-Product description – a copy of a leaflet or flyer will do (a website in English can suffice as well).
-Claimed intent of use
-Short description of the Mode of operation
-Any supportive evidence of their CE – EC Declaration of conformity, CE certificate or other certificates of compliance
LEGALIZATION of a Free Sales Certificate:
Non-European Authorities may request the Free Sales Certificate to go through a Legalization process which consists of 3 institutions in the issuing country:
1.The Chamber of Commerce
2.The Ministry of Foreign Affairs
3.The Relevant Embassy