European Regulatory Requirements - CE Marking
The "CE" symbol,
also called the "CE Mark" is affixed to products that are marketed in the
European Common Market (European Union, EU).
The symbol indicates that the product meets the requirements of all
the relevant EU Directives and can be legally sold within the EU.
The individual national rules covering the sale of products have been
replaced by a single set of regulations known as Directives which require
compliance with specific standards appropriate to the various products.
The Directives themselves are not technical standards.
Individual countries are required to ensure that their laws governing
product sale meet the requirements of the Directives adopted by the Council
of European Communities.
As of 1997 there were approximately 300 Directives. Each Directive contains
unique requirements for the manufacturer/supplier to demonstrate compliance.
A product may be required to meet the requirements of more than one Directive.
Manufacturer's Declaration of Conformity
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Prior to the import and distribution of products within the EU, documentation
must be submitted asserting that the specific product has met the requirements
of the relevant EU Directives.
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It is the responsibility of the manufacturer /importer to submit the paperwork
in the application for the CE Marking. However independent testing organizations,
which must be fully accredited by national authorities and accepted by
the EU Commission as a Notified Body, assist in demonstrating
that the specific product has met the requirements of the relevant EU Directives.
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The documentation or Technical File (TF) must be prepared
to support the Declaration of Conformity and must contain an explanation
of how the manufacturer has complied to the Directives. The TF must contain
comprehensive test reports, drawings etc.
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Each Directive specifies where the support documentation must be kept and
for how long. This is required in case the manufacturer is called upon
by the authorities to respond to an investigation.
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In some Directives, such as the medical devices Directive, follow-up services by a Notified Body may be required.
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The following are some of the categories which have mandatory CE Marking
requirements in force at this time: EMC, Machinery, Telecommunications
Equipment, Low Voltage Devices etc.
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There are transition periods in which products may conform to either the
old national regulations or the new Directives. Medical Devices Directives
became mandatory in June 1998.
TTi's new Metrology Specialist and Electronic Design
Specialist Programs will be of benefit to ensure that the correct procedures
and techniques are followed in the design and testing for EMI, EMC and
ESD. Course 161 "Grounding & Shielding for EMI/EMC/ESD"
and Course 162 "Test Procedures for EMI/EMC/ESD"
are presented at regular intervals. See our schedule for upcoming dates. Make
your reservations as soon as possible since we are accepting only fourteen
students in each class.
Toll-free tel. 866-TTi-4Edu (866-884-4338)
E-mail: Training@TTi4edu.com
© Technology Training, Inc. 2006
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