Most products covered by New Approach
Directives can be self-certified by the manufacturer and do not require
the intervention of an EU-authorized testing/certifying company called a
notified body. To self-certify, the manufacturer must assess the
conformity of the products to the applicable directives and standards.
While the use of EU harmonized standards is voluntary in theory, in
practice the use of European standards is the best way to meet the
requirements of the CE marking directives, especially in the case of the
Electromagnetic Compatibility (EMC) and Low Voltage Directives. (The word
"harmonized" means that the standards have been approved by all 27
European Union countries). The standards offer specific guidelines and
tests to meet safety requirements, while the directives are more general
and do not, in most cases, offer detailed specifications on how to meet
safety requirements. The Machine Directive, however, does offer more
detailed information on how to meet safety requirements than most other CE
marking directives. U.S. companies can self-certify to the CE marking
requirements of the Machine Directive by meeting the provisions of the
directive whether they use European, international or U.S. standards.
The manufacturer may affix the CE marking
to his product once he's prepared a declaration of conformity, the
certificate which shows the product conforms to the applicable
requirements. He must maintain a technical file to prove conformity. The
manufacturer or his authorized representative must be able to provide this
certificate together with the technical file at any time, if requested by
the appropriate member state authorities.
There is no specific form for the
declaration of conformity but specific information is required. The
declaration must include the following:
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the manufacturer's name and address; |
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the product description; |
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the CE marking directives that apply to the product |
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the European standards used; and, |
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the signature of a company official for purposes of the
company assuming liability for the safety of its product in the
European market.
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