A. ‘CE’ stands for Communauté Européenne (European Community). CE Marking was introduced in the year 1995 &it’s purpose was to promote the free movement of goods within the European Community.
CE marking can be applied to any type of product where ‘CE Mark’ can be fixed. In CE Marking a manufacturer of the product or equipment or its authorized representative has to declare complies with all applicable European Directives.
A. Yes CE Marking is a mandatory (legislative requirement) in most of European countries & in other continents it is trusted as a ‘mark of safety’ or ‘Mark of quality’. CE Marking on a product indicates that the product meets compulsory requirements defined in the applicable Community
The ‘CE Mark’ symbol is affixed by manufacturers or their authorized EU representative. In exceptional cases, when permitted by the directive, it can be affixed by the party responsible for putting the product on the market in the EU. It must be affixed at the end of the production phase and be of an appropriate size (no smaller than 5 mm) and, where possible, must be placed on the product or the data plate. A ‘CE Mark’ on a product must be visible, legible and indelible
A technical file is a products ‘biography’ & it contains all information about a product which includes : product picture, drawings, components / raw materials, product flow chart, QC / QA program, testing done along with test parameters, product safety guidelines etc. A technical file contains all the evidences required to support the declaration of conformity. Each directive in CE Marking specifies the content of the technical file. The technical file requirements for each directive are slightly different from each other. Atechnical file must be kept secured and made available for inspection when required by an enforcement authority for a period defined in the directive. For example: In the case of the machinery directive, the period is 10 years after the last product was manufactured.
A. When we combine two or more CE marked products, it doesn’t always make a CE compliant product automatically. It may happen due to many reasons for example, components can fall under directives which may not be exactly applicable on final product or final product needs to comply with some additional requirements which components doesn’t meet.
A. CE Marking is a legislative requirement of Europe so a product must meet requirements of it’s applicable directive. To get knowledge of the scope of responsibilities, you can refer to Law 22/94, of 6th July, which regulates civil liability for damages caused by defective products, and which adapts the provisions of the Directive 85/374/CEE, of 25th July, to national law, aimed at achieving a standardized judicial regime within the EU with regard to such liability.For the shake of control, different European government sets annual inspection plans. Government may ban circulation of product & can blacklist the company for future
A. CE marking through a notified body gives a confidence that all necessary CE Marking Requirements has been met. But it is not necessary to go through a notified body in all products, in certain less critical products a manufacturer can make self declaration or can take services of any competent third party.