CE Marking Directives require that Manufacturers
and Exporters, not established in the EEC, BE REPRESENTED
in Europe and maintain a copy of their Technical File in Europe.
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Registering
of your Product with the Authorities before they are marketed
(if necessary) |
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Keeping your technical
file documentation ready and available for the
European Competent Authorities |
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Be responsible
for incident reporting before Competent Authorities, in
close liaison with the Manufacturer and distributors;
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Notification
of serious Product incidents to the Competent Authorities;
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Represent the
Manufacturer to the European Commission for consultation
in case of withdrawal of a Product by a Member State(s);
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Keep
at the disposal of Competent Authorities the report concerning
the critical evaluation of all data collected during the
evaluation; |
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Represent the
Manufacturer before the national Competent Authorities
in the European Economic Area; |
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Be available
at all times to interact between the Manufacturer
and the national Competent Authorities; |
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Be informed
by the Competent Authorities of any incident(s); |
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Notify
the Competent Authorities as to which investigations are
to be conducted; |
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Act as your primary
contact point for the EU Authorities; |
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Protect your
documentation confidentiality because the Authorized
Representative is authorized to show them to the Competent
Authorities only. |