Page 13 - CE Marking

PART 3 CE-Marking
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M ost manufacturers trying to get their products CE-marked
use so-called ‘standards’ to match their product to the
requirements laid out in EU directives. Although you’re free
to choose your own technical standards, the harmonised EU standards
are generally considered to be the safest bet, as they provide a so-
called ‘presumption of conformity’ with the essential requirements.
They’re based on best practices and provide an effective method for
implementing the requirements. If these harmonised EU standards
are not yet available for your particular product, national standards of
EU member states are the second choice.
The technical and administrative procedures you have to go through
to get the CE-mark reflect the aim of CE-marking to guarantee product
safety. The third step in the process concentrates on the technical
aspects of the conformity assessment procedure. If you look at the
New Approach directives (see Parts 1 & 2 of this series), you’ll notice
that they all include the same conformity assessment procedure. It
is subdivided into eight modules, comprising a limited number of
procedures applicable to the widest range of products. The eight
modules cover both the design and the production phase of your
product and help you find out which inspections and tests are needed
In the previous article within this series, we looked at the first two steps in the
process of CE-marking a product: determining the product’s application and
establishing which EU directive(s) apply to it. In this article, we will look at the
third step: figuring out how to meet the requirements set forth in the directives
and carrying out a risk assessment or analysis. In other words, making sure
your product is safe and being able to prove it. This is where the CE-marking
process gets really complicated.
PART 3 : MEETINg REQUIREMENTS
AND ASSESSING RISKS
Conformity Assesment Procedure