Page 15 - CE Marking

PART 3 CE-Marking
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Depending on the product and its use, the risks will obviously
differ. Therefore the requirements as to which modules have to be
implemented will differ as well. In many cases, you might carry out
the necessary tests yourself, provided you have the knowledge.
Self-testing is allowed as long as there is no high risk, for example
if your product is a toy. For products that do involve high risks and/
or products subject to several different directives, such as medical
devices, machines and personal protective equipment, self-testing
and so-called first-party testing are not allowed. In those cases, you
have to submit your product to third-party testing by a so-called notified
body. Notified bodies are bodies that have been recognised by EU
member states to be technically competent and capable of carrying
out the conformity assessment procedures in question.
If a directive states that a notified body is required, there are several
options to choose from. One is to apply standards yourself and to
refer to a notified body for a final check. The notified body will assess
each of the steps you’ve taken, checking which standards you’ve
applied, which risks you’ve found, what you’ve done to reduce risks
and so on. A second option is to let the notified body take charge of
the whole test procedure. Then the notified body will have to check the
product itself, as in the case of a type approval. A type approval can
be given after a type-examination has been made – an assessment by
a notified body of a sample product representing a series of products
of the same type. For products with a very high risk factor, an EC
type-examination is necessary. Moreover, annual, on-site inspections
may be required. Again, the directive will tell you whether this is the
case for your product.
As a non-EU manufacturing company that wishes to export to the EU,
you still have to find a notified body within the EU. Notified bodies
provide services ranging from checking technical documentation to
entire type-examinations and quality system checks. Please note that
not every notified body is authorised to carry out tests for all directives.
Self-testing And Notified Bodies