CE is an abbreviation of French phrase “Conformite Europene”, which means ‘European Conformity’. In earlier days, the term ‘EC’ used instead of CE but later through the COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993, it was replaced by ‘CE’. The basic need for such marking is to express about the safety standard of the product. As like ISO, CE marking is not a quality mark, rather it an indication of safety standards.
It is also not an indication of origin, so it doesn’t need that the product should be produced within Europe, any products manufactured outside also can affix the mark. Another thing, there is no authority to approve the CE marking, it solely lies on the manufacturer to comply with standards in order to affix the mark and some cases it needs to access by a designated third party. Not all the products require the CE marking, a certain set of products expressed by the EU legislation needs the CE marking. Some of them are machineries, electrical and electronic equipment, Medical devices, Toys, construction products and Personal Protective Equipment.
CE marking is a conformity marking. By fixing the CE marking the manufacturer indicates that the product complies with the safety, health and environmental protection with complying to the standards of European Legislation. It lies with the manufacturer to verify the product comply with the legal requirements before affixing the mark, if not he shouldn’t affix the mark. In some cases, it is required to be examined by the designated third party conformity assessment body. And also it considered the affixation of the mark is a declaration by the manufacturer regarding the fulfillment of requirements so the responsibility lies with him.
The CE marking rules harmonized the product requirements of standards throughout Europe, the CE mark plays a vital in the circulation of products in EEA. So, once the manufacturer got affixed by the mark, the product can circulate freely in and all over the European Economic Area (EEA) viz EU countries, Norway, Iceland and Liechtenstein. Once the mark affixed there is no need of additional certification and approval for such circulation of the product in the market. The rule regarding the expression of CE mark, it should be visible and with the requirements made in the legislation, in case any other symbols, standard marks affixed with the CE mark it shouldn’t impair the CE mark.
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The procedure for obtaining of CE marking varies from products to products, nature of risks involved. Firstly find the directives of EU which will apply to your product. In case two or more applies it requires to comply with all of them. Then ascertain the degree of compliance of your product with the requirements. Once done, choose the conformity assessment procedure form the options on the modules with respect to the requirement.
The procedure is with a set of questions and process to find out the degree of risk, which will be resultant in the expression of the chart, from the chart the manufacturer can identify the risk and go for the further process. In case the products are with minimal risk, the product can be self-certified by the manufacturer by a declaration of conformity and then affix the mark. If the products are with greater, then the directives require a notified body to access the product and to deliver the report of safety. So there is another procedure in order to get the product certified by a notified body. For that, the manufacturer needs to select the test method and notified body.
Countries part of CE marking and access to european market
Then establish an authorized representative in the EU for the product that is for technical documentation. After to it declaration of conformity, in case registration of the product in EU required should be done and wait for the opinion then affix the mark. CE marking not only regulates the manufactures it also gives certain duties and liabilities over the importers and distributors in EU. These many restrictions and regulations for the CE marking are all about the safety of the product with an ultimate object that the consumer of EU should enjoy the same degree of health, safety, and environmental throughout the whole EEA.
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