CE Mark

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What is it?
The CE Mark ('Trade Passport to Europe') is a visible declaration by the manufacturer (or his representative, importer, etc.) that the equipment which is marked complies with all the requirements of all the applicable directives. This mark allows manufacturers and exporters to circulate products freely within the 15 European Union (EU) members. Having ensured that the equipment does indeed meet all these requirements (including all the administrative requirements involved in being able to demonstrate compliance), the CE Mark may then be affixed and the product released.
The letters, "CE", indicate that the manufacturer has undertaken all assessment procedures required for the product. The CE mark is not a quality mark and does not indicate conformity to a standard; rather, it indicates conformity to the legal requirements of the EU Directives.
Why is it important?
The "CE" mark is now mandatory for regulated products sold in the European Union. This applies to prototypes and commercial freebies. One of the objectives of the EU is the realization of a single European market in which products can be traded freely without any trade restrictions. The adoption of the CE Marking offers manufacturers and exporters advantages by eliminating differing national product regulations among members of the EU and the signatory states of the European Economic Area Agreement.
When to use it?
For most equipment, there is a self-certification route to compliance. Broadly, this involves ensuring equipment complies with certain harmonized European Standards, ensuring that this compliance can be demonstrated, and then compiling the requisite documentation and certification.

Often, CE Marking directives require certification of quality management systems to ISO 9000 standards.
The following are excerpts from a CE informational pamphlet issued in April of 1997 by the National Institute of Standards and Technology (NIST), The U.S. Department of Commerce and Dr. S.I. Warshaw
How to use it?
There are about 30 Directives, either adopted or under consideration, which require that products be marked with the CE mark. More than one Directive can apply to many given products.
• Identify all applicable EU Directives (laws)
• Assess your product to the "essential requirements" contained in the Directives.
• Choose the appropriate conformity assessment module (Fig. 1); i.e., self certification or manufacturers declaration under Module A, or one of the other modules where the use of third parties is required.
• Determine the applicable standards, international, European or national.
• If required, choose a "competent body" in the U.S. to perform test on products (an updated list is maintained by the U.S. Department of Commerce).
• If desired, choose an authorized representative for your company in the EU.
• Prepare a technical file, including a users manual, particularly for products with high risk hazards.
• Assemble the required approvals and certificates and prepare a Declaration of Conformity for each applicable Directive. Declarations of Conformity and technical files can be maintained in English.
• Affix the CE mark in accordance with the laws (the format of the CE mark and its proper location is described in Directive 93/44/EEC, dated 1 January 1997.)
• These are excerpts from a CE informational pamphlet issued in April of 1997 by the National Institute of Standards and Technology (NIST) along with other departments.
The CE marking must be affixed visibly, legibly and indelibly. Where special provisions do not impose specific dimensions, the CE Marking must have a height of at least 5 millimetres.

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