CE Mark
The
CE marking (also known as CE mark) is a
mandatory conformity mark on many products placed on the
single market in the European
Economic Area (EEA). The letters "CE"
do not stand for anything. The term initially used was
"EC Mark" and it was officially replaced by
"CE Marking" in the Directive 93/68/EEC
in 1993. "CE marking" (not CE
mark) is the official term now used in all new EC
directives. "CE mark" is also in use but
it is not the official term. For instance, in the
Directive 2007/47/ec, of 5 September 2007, amending the
directives 90/385/eec, 93/42/eec & 98/8/ec Pranesh , the term CE Marking
appears 9 times whereas CE Mark appears nowhere in
the entire 35-page document.
Significance
By
affixing the CE marking, the manufacturer, its
authorized representative, or person placing the product
on the market or putting it into service asserts that the
item meets all the essential requirements of the relevant European
Directive(s). Examples of European Directives
requiring CE marking include toy safety, machinery,
low-voltage equipment, R&TTE,
and EM
compatibility. There are about 25 Directives requiring CE
marking.
Officially,
CE has no meaning as an abbreviation, but may have
originally stood for Communauté Européenne or Conformité
Européenne, French for European Conformity.
Declaration
of conformity
The
CE marking is a mandatory European marking for
certain product groups to indicate conformity with the
essential health and safety requirements set out in
European Directives. To permit the use of a CE mark
on a product, proof that the item meets the relevant
requirements must be documented. Sometimes this is
achieved using an external test house which evaluates the
product and its documentation. Often it is achieved by a
company-internal self-certification process. In any case
the responsible organization (manufacturer,
representative, importer) has to issue a EC-Declaration
of Conformity (EC-DoC) indicating his identity
(location, etc.), the list of European Directives he
declares compliance with, a list of standards the product
complies with, and a legally binding signature on behalf
of the organization. The EC-DoC underlines the sole
responsibility of the manufacturer. Parts of the
certification process for the CE marking could be
performed by 3rd party test houses or certification
bodies; in case that this is mandatory the CE
symbol also includes a number that identifies the so
called Notified Body.
To
be strictly accurate, there are two forms of Declaration,
either a "Declaration of Conformity" or a
"Declaration of Incorporation". Generally
speaking this is only the case under the Machinery
Directive, for example, a stand alone machine, which
requires only a power source to operate would be issued
with a Declaration of Conformity. Whereas, a machine which
requires additional systems, attachments, feed conveyors
etc, before it can provide its intended function, must be
issued with a Declaration of Incorporation. In this latter
case it is illegal to CE Mark such a machine. This
can only be achieved once the machine has been finally
installed and all other elements incorporated into the
system, then a final Risk Assessment is performed to
verify compliance of the system and a final Declaration of
Conformity is then issued.
Furthermore,
these directives are based upon what the European
Commission calls a New Approach, whereby if any of the
Article 100A Directives apply to your product, then you
must apply them. More information on these and other
directives can be found at [1]
or [2]
Directives
providing the requirements for the CE marking are
created by the European
Union (EU), but the markings are required
throughout the European
Economic Area (EEA). According to information
provided by the Swiss Government for Swiss Exporters
the CE Mark is not compulsory in Switzerland except
for products for export to the European Union.)
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