The CE marking scheme is a product of the European Union's
"New Approach" to product conformity. Prior to implementation of the "New Approach
Directives" there was a myriad of conflicting standards from one European country
to another. These conflicting standards impeded the free movement of goods across
boarders of the member states. The "New Approach" Directives created a structure
wherein one-standard, one-test, one-mark would be accepted by all member states
of the European Union.
The
CE Mark
Products entering the European Union that are intended to be placed
on the market must bear the "CE" mark. Preferably the CE label will be affixed
to the product itself, however the mark may also be applied to product packaging.
Application of the "CE" logo (Conformity European) signifies a claim by the
manufacturer or his agent that the product to which it is affixed, complies
with all applicable "New Approach" Directives. It is illegal to apply
the mark to a product without the existence of the required "proof" in the form
of supporting documentation.
The
Declaration of Conformity
Proof of conformity is in the form a "Declaration of Conformity"
(DoC). This declaration must be supported by a "Test Record" or "Technical File".
Listed on the "DoC" are the specific "Harmonized Standards" to which the product
conforms. It is a "self Declaration" of Conformity in that it is the manufacturer's
affirmation that the product is in compliance with the "Essential Requirements"
of all applicable European Directives. The DoC is signed by an officer of the
company or one who can legally bind the assets of the company. (If your company
does not have an office located in the European Union, the Declaration of Conformity
is signed by the importer who is located in the European Union.) Evidence supporting
a claim of conformity, must be kept on file and be made available for inspection
by European Officials seeking such evidence of conformity.
The
Technical File
There is a "presumption of conformity" with the "Essential
Requirements" of applicable "Directives" when a product is successfully tested
to all applicable "Harmonized Standards". For this reason a DoC will nearly always
cite the specific "Harmonized Standards" to which testing was performed. The test
reports included in the technical file, held by the manufacturer, should include
clear references to these standards by number and indicate the test levels applied.
In cases where compliance with the EMC Directive is not based upon testing to
Harmonized Standards, the DoC will reference the "Certificate Number" obtained
from a European Competent (EMC) body. It should be noted that, while a product
may comply with all requirements of applicable "Harmonized Standards", it may
not meet the "Essential Requirements" of a particular European Directive. Neither
does the existence of a DoC itself imply product Certification.
