Page 18 - CE Marking

PART 4 CE-Marking
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STEP 4: Technical Documentation
As a manufacturer, you will have to draw up technical documentation,
also known as a technical file. This documentation is intended to
provide information on the design, manufacture and operation of
your product. If you do it right, your technical documentation will
demonstrate the technical basis for your products’ conformity to the
legal requirements. The contents of technical files will vary from
directive to directive, depending on the product. Generally speaking,
your documentation should include the following items:
• A general description of the product;
• A list of standards applied;
• Inspection and test reports;
• Detailed technical data for essential aspects of the products;
• A declaration of conformity.
It is your responsibility as a manufacturer to make the technical
documentation available for national authorities in the EU for inspection
and control purposes. You can, of course, delegate this responsibility
to an authorised representative in the EU. Also note that unless
otherwise indicated your technical file should remain available for at
least ten years.
STEP 5: User Manual
One of the main objectives of the EU directives is to make sure that
the products that find their way onto the European market are safe.
Clear instructions on how to use a product can contribute to this goal.
Products that bear the CE-mark have to be supplied with certain
instructions for the end user. Again, there are different requirements
for different products. A proper user manual generally includes legal
obligations and clear documentation, stating the purpose of the product
and the risks related to its use under normal circumstances. A good
user manual will include the following elements:
• Information on risks;
• Instructions on how to use the product safely;
• A description of possible hazardous applications;