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MedDARE,
the easy solution for non EU companies to meet EU
and national requirements.
For
non EU companies seeking their place on the European
market, MedDARE provides a simple and intelligent
solution to meet mandatory European Representative
requirements. Through expert regulatory know-how and
close contacts with Competent Authorities and European
Commission, MedDARE is the EU Authorized Representative
of choice.
Important
things you should consider:
•
Non EU companies require a representative domiciled
in the EU prior to placing
their devices on the EU market.
•
National authorities will require an EU representative
during clinical
investigations with non CE marked devices.
•
Competent authorities expect high level expertise
from EU representatives.
•
Different national requirements exist for specific
product procedures,
market access notifications, labelling
and vigilance reporting.
To find out how MedDARE can make your European debut
a success,
contact us today.
MedDARE Sàrl
136, Route de Genève 74240 Gaillard, France
Tel +33 450 49 53 11 Fax +33 450 49 53 11
info@meddare.com
www.meddare.com
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