By Miguel Ohn What is a CE mark? A CE mark is a mark placed on products by their manufacturer that act as a statement that the product meets all the standards and requirements of the relevant legislation according to the appropriate European Directives. CE Marking gives companies easier access into the European market to sell their products without adaptation or rechecking. What does CE stand for? The initials CE stand for Conformit Europenne, which is French for “European Conformity. This mark indicates that the manufacturer has ensured each of their products bearing this mark have undergone testing and conform to the standards set forth in the European Directive(s) applicable to each product respectively. How do I get a CE mark for my product if it does indeed require such a mark? To obtain a CE mark, each manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis (O.E.A.R.C.) for steps tailored to your company and read below for some information about what this program involves. The next step of the CE marking process is to choose a Notified Body (link to our web-list of N.B). Before choosing a Notified Body, it is important that you select your European Authorized Representative. Your European Authorized Representative can particularly assist you in classifying your product before submission to the Notified Body and can also guide you through the Manufacturer Responsibilities. Appointing Obelis European Authorized Representative Center (O.E.A.R.C.) as your “European Authorized Representative” within the EU will make your endeavors into European markets simple and successful. Obelis European Authorized Representative will provide you with a CE mark by first creating your personal compliance program through the following steps: Assist you to identify all applicable EU Directives (laws) for your product Guide you in determining the applicable Standards - European, International or National Assist you in assessing your product according to the “essential requirements” in the Directives. Article 11 of the MDD describes the available conformity assessment routes, and detailed information on the assessment “modules” are given in Annexes II.VII of the MDD Direct you on how to identify the appropriate conformity assessment module according to your product classification Assist you to prepare a “Technical File”, including a user manual, as outlined in the Directive (MDD 93/42/EEC Annex VII) Guide you in how to implement and operate a “Quality Assurance System”as required in Section 3 of Annex II Assist you, if required, in selecting a “Notified Body” within the EU Territory, to perform the official conformity assessment tasks To obtain your CE mark, you must do the following: Assemble the required approvals and certificates Prepare an “EC Declaration of Conformity” per product according to the applicable Directives. (Note that the Declarations of Conformity and Technical Files can be written in English.) For assistance with either of these tasks, contact Obelis European Authorized Representative Center (O.E.A.R.C.) today. For important Manufacturer’s Obligations, see our article entitled “The Role of Non-European Manufacturers.” Where does the CE mark have to appear? In most cases, the CE mark must appear on your product but there are exceptions. In general though, the CE mark must appear on the packaging and in the manuals or other support literature of your product. Contact O.E.A.R.C. for full details on where the CE mark must appear on your specific product. What is the design of the CE mark? Where can I get the graphics file? The CE mark is just as its name implies, the letters C and E. The mark must not be less than 5mm in its vertical height and the proportions maintained. In guidance booklets it is usually shown on a grid (see image below). Both the C and the E are in close to perfect semi-circles with a small arm in the middle of the E. The graphics file is available for download from commercial sources only and not by any official sources. To obtain the official graphics, contact Obelis European Authorized Representative Center today. Who enforces the CE mark and what would happen if my product did not bear the CE mark? The enforcement of the CE mark varies depending upon the Directive that applies to each specific product. For a complete listing of Directives, please see the European Directives page. Or for more personalized answers to your questions, contact Obelis European Authorized Representative Center today by phone or email. In general though, the procedure for enforcement or penalties of selling a product which does not bear the CE mark will begin by providing you the opportunity to properly affix the CE mark to your product. Failure to comply with this requirement once ample time has been provided to allow you to do so will result in you being required to remove your product from the market. In addition to removing your product from the market, you may also be liable for a fine or imprisonment. In circumstances where safety is at risk, the penalties will be greater. What requirements do I have to meet to export my product? CE marking is a requirement only applicable to product circulation within the European Union (EU). Exporting products outside of the EU do not require the CE mark. In addition to the CE mark, each country within the EU may have regulatory requirements or standards specific to their country. You must check the exact requirements of the country you wish to export. Obelis European Authorized Representative Center would be happy to advise you on any of the country specific requirements you may need. What are Notified Bodies? How can I find one? Notified Bodies are bodies appointed by each Member State within the European Union. Notified Bodies perform third-party conformity assessment procedures on the product in question to ensure the product is compliant with the EU Directives. One conformity is confirmed, the Notified Body will allow a CE mark to be placed on the product and allow the product to circulate within the EU. Manufacturers desiring to sell products within the EU can use the services of any Notified Body within any of the Member States. What standards must my product abide by? The standards that your product must abide by presume that your product already complies with the EU Directive that is applicable to the specific product. To learn more about the standards that may apply to your product, please contact Obelis European Authorized Representative Center today. Where can I get specific technical file assistance? Technical files, as required by the EU Directives, must always be updated and kept current with your European Authorized Representative. To get assistance with your technical file, please contact Obelis European Authorized Representative Center today. The EU member states include: Austria, Belgium, Denmark, United Kingdom, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, and Slovenia. The European Free Trade Association (EFTA) members include all of the above EU states, plus: Iceland, Liechtenstein, Norway, and Switzerland. Candidate Countries: Bulgaria, Romania, Croatia, and Turkey Miguel Ohn - O.E.A.R.C. Project Manager Article Source: http://EzineArticles.com/?expert=Miguel_Ohn http://EzineArticles.com/?CE-Marking-Explained&id=156949
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