CE MARK is Product Certification for EU market. The CE marking indicates a products compliance with EU legislation and so enables the free movement of products within the European market. By affixing the CE marking to a product, a manufacturer declares, on his sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (EEA, the 28 Member States of the EU and European Free Trade Association (EFTA) countries Iceland, Norway, Liechtenstein). This also applies to products made in other countries which are sold in the EEA.
It is the manufacturers responsibility to carry out the conformity assessment, to set up the technical file, to issue the declaration of conformity and to affix the CE marking to a product. Distributors must check that the product bears the CE marking and that the requisite supporting documentation is in order. If the product is being imported from outside the EEA, the importer has to verify that the manufacturer has undertaken the necessary steps and that the documentation is available upon request.
GENERAL PRINCIPLES OF THE CE
- 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.
- 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
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:
- Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
- Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
- 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
ModuleAa: 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
ModuleH: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.
HOW CAN DCS HELP TO GET CE
- DCS ensures that the products of a company comply to the CE Marking and CE certification regulations.