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The CE marking certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. A manufacturer who has gone through the conformity assessment process, may affix the CE marking to the product. With the CE marking, the product may be marketed throughout the EU. CE marking now provides product access to 27 countries with a population of nearly 500 million.

Unfortunately, there is no comprehensive list of the products that require a CE marking. Therefore, it is the manufacturer's responsibility to determine if a product requires a CE marking. The "New Approach Directives" are documents that contain the legislation issued by the European Commission on the requirements that need to be met and procedures that must be followed in order for a particular product to be CE marked for sales in the EU.

General principles of the CE marking

  • The CE marking shall be affixed only by the manufacturer or his authorised representative.
  • The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.
  • By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
  • The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing.
  • The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
  • Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.

How to achieve CE mark approval, CE testing and meet all CE mark requirements, for my product?

There are a series of steps outlined below for CE mark approval. Depending upon your product and the nature of the risks it presents:

  1. Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
  2. Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
  3. Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below:
    Module A: internal production control
    Module Aa: intervention of a Notified Body
    Module B: EC type-examination
    Module C: conformity to type
    Module D: production quality assurance
    Module E: product quality assurance
    Module F: product verification
    Module G: unit verification
    Module H: full quality assurance
The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

Minimal Risk

Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.

Greater Risks

Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union.

A Notified Body is usually able to offer some of the services required:
  • product testing
  • type examination certificate issue
  • Technical File and design dossier evaluation
  • surveillance of product and quality system
  • identification of standards

 

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