Hi Ann,
Medical devices that are notified within the EU are in free circulation within the EU. This means that trade of medical devices within the EU to other European countries can be done without restriction (although some local charges may still apply).
When exporting medical devices from the EU to a third country a Certificate of Free Sale (CFS) might be asked to provide to the government of that third country. The CFS contains a declaration from the government in which the manufacturer resides that the applicable product(s) are in free circulation within the EU and that it may exported outside the EU.
A CFS therefore only can be issued for EU based manufacturers by their national competent authority.
US based manufacturers can ask FDA to issue a FDA Export Certificate. See the following link for more information:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm
I hope this helps Ann.
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Paul Kooijmans
Regulatory Affairs manager
Eurotrol B.V.
Ede
Netherlands
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