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STEP 1 |
Identify the Directive(s) that
are applicable to your product. You
can download these directives free of charge from
the European Union website |
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STEP 2 |
Identify
the conformity assessment procedure that must
be taken. This could be self-declaration, involve
testing, inspection or quality system assessment
from a Notified Body or a combination of these.
The conformity assessment procedure will differ
depending on your product and the Directive in respect
of which you will be CE marking. |
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STEP 3 |
Determine
the dates by which you must take action. This
will be the date that the Directive comes into force.
The majority of directives are already in force.
In these cases, it is an offence to place a product
on the market without CE marking because it indicates
a presumption of conformity with all relevant Legislation. |
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STEP 4 |
Identify
if there are any Harmonised European Standards applicable
to your product. These are not always mandatory
for manufacturers although there is a presumption
that conformity to these standards will give conformity
with the relevant part of the Directive. Whenever
possible or appropriate, manufacturers should follow
harmonised standards. |
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STEP 5 |
Ensure the
product complies with all the essential requirements
of the Directive(s). Take appropriate measures
to comply or identify existing data and test reports. |
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STEP 6 |
Identify
whether independent assessment of your conformity
to the Directive, or some aspects of it, is
required from a Notified Body. This will be stated
in the directive and is dependent upon the product
you are CE marking. You must not affix CE marking
to your product until all necessary certifications
have been obtained from the Notified Body. |
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STEP 7 |
Maintain
Technical Documentation required by the Directive(s).
Your technical documentation should support your
compliance with the requirements of the Directive.
It is essential to retain this documentation. |
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STEP 8 |
Prepare
the Declaration of Conformity and the required supporting
evidence. The Declaration of Conformity along
with the Technical Documentation should be available
to Competent Authorities (EU Members) upon request. |
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STEP 9 |
Check that
no other purely national requirements exist
in the countries where the product will be sold.
These may include national standards, labelling
or packaging requirements. |
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STEP 10 |
Affix CE
marking on your product and/or its packaging
and accompanying literature as stated in the directive.
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