|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.
|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). Check out National Institute of Standards and Technology (NIST) - A Guide to EU Standards and Conformity Assessment.
|Assess your product to the "essential requirements" contained in the Directives. (Basic Principles of Compliance - CE Marking ); CE Basics from from UK's Department of Trade & Industry (DTI).
|Choose the appropriate conformity assessment module; i.e., self certification or manufacturers declaration where the use of third parties is required.
|Determine the applicable standards, international, European or national. European Commission Website on Directives.
|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. (for example - Obelis).
|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).
|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.
|What's on the web?
|New Approach Standardisation in the Internal Market | A-Z Index of European Union Websites.
The US Commerce Department on CE Mark.
Directives are the mechanism by which European-wide legislation is enacted. Directives are issued from Brussels (after consultation and agreement by member states). These are then adopted by each state by the incorporation of corresponding legislation according to their own national legal framework. EC Directives are issued covering a whole host of matters, however of particular relevance are certain Directives known as the 'New Approach Directives'. These are a set of Directives which serve two primary purposes. Firstly, they ensure that all products which are covered by them are safe, by specifying requirements, (principally safety related) which the products must meet. Secondly, they provide a 'level playing field' for products within Europe, by the introduction of a single market. All products which meet all the requirements of the directives may be freely marketed anywhere within the European Economic Area without further approvals being required.
Special thanks to Dr Harry Angelopulos, Unicon, Athens, Greece for suggesting this topic.
|Food for Thought !
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