Declaration of Conformity
The declaration of conformity provided for in Article 1O of the Directive
is important both for
assessment of the conformity of the apparatus and for the procedure for
monitoring the market.
The declaration of conformity is drawn up by the manufacturer or by the
manufacturer's authorized
representative established within the Community.
Where neither the manufacturer nor his authorized representative is
established within the
Community the obligation to keep available the CE declaration of conformity
shall be of the
responsibility of the person who places the apparatus on the Community
market.
A copy of the declaration of conformity is kept at the disposal of the
competent authority for
inspection purposes under the same conditions as the technical file.
Paragraph 1 of Annex 1 of the Directive describes the content of the
declaration of conformity,
which must include the following:
description of the apparatus to which it refers,
reference to the specifications (1), under which conformity is
declared and, where
appropriate, to the internal measures implemented to ensure the
conformity of the apparatus
with the provisions of the Directive,
identification of the signatory empowered to bind the manufacturer or
his authorized
representative,
where appropriate, reference to the EC type-examination certificate
issued by a notified
body.
The declaration of conformity must be written in one of the official
languages of the Community.
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