The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. The letters 'CE' are an abbreviation of Conformité Européenne. The CE mark must be affixed to a product if it falls under the scope so called New Approach Directives.
The CE mark is not a quality-mark. First, it refers to the safety rather than to the quality of a product. Second, most quality markings are voluntary opposite to the CE marking, which is mandatory for the products it applies to. CE indicates conformity with mandatory European safety requirements. European conformity is certified by following clear and understandable procedures, the so-called ‘conformity assessment procedures’.
Why CE marking?
The European CE certification procedure has been mainly set up to:
1.Harmonize all varying national regulations for consumer and industrial products in European Member States, so that the Single Market is encouraged;
2.Bring about cost savings for producers;
3.Enhance the safety of products;
4.Supply public bodies with a uniform procedure that can be checked.
Formerly, product requirements and test procedures were set by the Member States of the EU. This meant that, for example, companies that wanted to sell their products on the European market sometimes had to deal with more than ten different technical requirements or procedures for just one product. The existence of all the different national legislation was contrary to the aim of the European Union in realizing one Single Market, in which there would be a free circulation of goods (as well as a free circulation of persons, services and capital).
All the different product requirements brought many costs for the producers. With the help of the CE Directives or 'New Approach' Directives, the measures have been optimized by setting up European (European-wide) requirements, the harmonization of national legislation and directives, standards and mutual recognition of the technical standards, tests methods (compliance tests) and test laboratories, so that producers no longer need to adapt their products to the different markets.
During the process of harmonization the safety level of all products was attuned and raised. In most European countries, safety and health had already been the subject of directives for many years but the safety level was not always satisfactory.
With the help of the conformity assessment procedures, the authorities can ascertain that the products that are placed on the market comply with the requirements as stated in the regulations of the directives. The CE marking is consequently largely for the benefit of the authorities. However, safe products are also necessary for the end user in the work or consumer environment.
The steps of the CE marking and CE certification procedure
Before the CE marking may be affixed to a product, the essential requirements of the applicable European Directive must be met. Moreover, the conformity of the product must be proved by following a testing and/or certification procedure. Besides some administrative steps this can mean that a risk analyses must be performed or that the compliance must be tested in a laboratory.
Please visit www.cemarkindia.com or call us on +91 994 591 2081(India) where you will be informed about:
- CE marking and certification procedure: What is CE marking? How can the CE marking be obtained? Where can I have my product tested?
- European 'New Approach' Directives applicable to your product
- How to meet the requirements of the European Directives and the conformity assessment procedures
- Testing and certification
European standards related to CE marking
 What is an apparatus?
A final product with an intrinsic function intended for the final user and intended to be placed on the European Union market as a single commercial unit. One or more devices may define the final user product. |
How can I determine if my product is a component or an apparatus? For a product to be classified as an apparatus it must meet four (4) criteria: A. It must be a finished product.
B. It is intended to be placed on the market as a single commercial unit.
C. It presents EMC hazards against which protection is justified.
D. It delivers a direct function. Additional clarification may be found in the following document, Guideline on the application of Council Directive 89/336/EEC on the approximation of the laws of the member states relating to Electromagnetic Compatibility amended by Directives 92/31/EEC and 93/68/EEC. |
How can I demonstrate compliance with the EMC Directive? A. Self Declaration- Subject your apparatus to the tests specified by European Normalized Standards. Compile a technical file to contain the apparatus' technical information and test results. Issue a Declaration of Conformance (DoC), affix the mark and hold a copy of the Declaration of Conformance. B. Technical Construction File(TCF) - for equipment not covered by standards or that is impractical to test. The manufacturer compiles a Technical Construction File containing information required to assess the EMC characteristics of the apparatus. The completed file is submitted to a Notified Body to determine if the file demonstrates that the apparatus will comply with the intent of the requirements. The Notified Body issues a report either indicating the apparatus is in compliance or detailing deficiencies. If deficiencies are noted, corrective action is taken by the manufacturer and the apparatus resubmitted for evaluation. If the Notified Body indicates that the apparatus is in compliance, the manufacturer can issue a Declaration of Conformance, affix the mark and hold a copy of the Declaration of Conformance. C. Notified Body- for apparatus for which Normalized Standards do not exist a Notified Body may recommend appropriate testing. This testing would be conducted by a Competent Body and reviewed by a Notified Body. When the Notified Body is satisfied that the apparatus is in compliance, the manufacturer compiles a technical file to contain the apparatus' technical information and test results. The manufacturer issues a Declaration of Conformance, affixes the mark and holds a copy of the Declaration of Conformance. |
Who are the country members of the European Union? Austria, Belgium, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, and Sweden. Additional countries that have expressed interest in joining the EU include: Czech Republic, Hungry, Norway, Poland, Slovakia and Turkey. |
Are the European Union national laws consistent for all members? Yes the European Union national laws are consistent and are mandated by the EU. |
Am I required to provide any documentation to support the marking? Yes. The mark on the product is required to be substantiated with a Declaration of Conformity (DoC). The Declaration of Conformity (DoC) needs to be supported with documentation kept on file by the manufacturer. The DoC must be " held at the disposal of the Competent Authority. |
What is a Declaration of Conformity (DoC)? A Declaration of Conformity (DoC) is a standardized document used to summarize the details of the apparatus' compliance and signal by an Authorized Representative of your company. |
How do I hold my DoC "at the disposal of the Competent Authority"? One approach is to provide the DoC as part of the owner's manual. |
How long must I hold my DoC "at the disposal of the Competent Authority"? You must hold your DoC "at the disposal of the Competent Authority" for ten (10) years after the product enters the market. |
Can a third party issue a Declaration of Conformity (DoC)? No. The manufacturer is required to issue the Declaration of Conformity (DoC) and is responsible for it's content. All other third party references and signatures have no legal standing. |
What are Normalized Standards? For a standard to be normalized it must meet three criteria: A. It must be identified by an "EN" designation. B. It must be published in the "Official Journal of the European Communities" (OJ). C. It must be adopted by at least one of the member states. |
What is “the mark”? “The mark” is a symbol, specified by law, which identifies an apparatus as complying with all applicable directives. All apparatus offered for sale within the EU must have the mark or they cannot be sold. Failure to have “the mark” can result in legal penalties. In this case “the mark” is the CE mark. |
Who can affix the mark to my apparatus? The mark may be affixed by the manufacturer after demonstrating compliance with all applicable Directives. |
What is a Competent Authority? A Competent Authority (a.k.a. National Authority) is generally the member state's government agency responsible for control of the RF spectrum. |
What is a Notified Body? A Notified Body is an organization, appointed by the EU member's National Authority (a.k.a. Competent Authority), which has the technical competence to evaluate compliance to a directive. They do not necessarily have test capabilities. |
Who are the Notified Bodies? Notified Bodies are those organizations that were formally the national experts. A complete list of Notified Bodies is published in the "Official Journal of the European Communities." |
Do I have to use a Competent Body to test my product to the Normalized Standards? When there are Normalized Standards, which are applicable to your apparatus, you do not need to utilize a Competent Body. |
If a Notified Body does not have test facilities, can they designate their authority? A Notified Body may only direct testing to designated laboratories on apparatus for which no Normalized Standards exist. The Notified Body then notifies the European Commission of the designated laboratory. These laboratories are designated as Competent Bodies. A Competent Body cannot certify your apparatus, the authority remains with the Notified Body. |
Who are the Competent Bodies? A Competent Body is an organization, located within the same member state as the Notified Body, that is authorized to conduct specific testing. A list of Competent Bodies is published in the "Official Journal of the European Communities." |
Can a company or organization not located in an EU member country become a Competent or Notified Body? A Competent Body is an organization, located within the same member state as the Notified Body that is authorized to conduct specific testing. |
What approvals are required to test in accordance with the European Normalized Standards? Contrary to the abundant marketing hype, no certification, accreditation, approval, European ownership or myriad of other supposed prerequisites exist. |
Who can conduct testing in accordance with European Normalized Standards? Once a standard is adopted anybody, including the manufacturer themselves, may conduct testing in accordance with the Normalized Standards. |
Where can I get the "Official Journal of the European Communities"? To obtain a subscription to the "Official Journal of the European Communities" by calling 800 274-4888 or contact the US Department Of Commerce, EC Affairs Office. |
Can I have testing performed by a US laboratory, self certify, and affix the mark? Yes, but is important to remember that the liability for the accuracy and completeness of the testing always remains with you as the manufacturer or your importer. |
Who should conduct my testing? Most manufacturers benefit from utilizing the services of an independent third party test laboratory.
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