Frequently Asked Questions
CE MARKING BASIC INFORMATION
"CE marking" is a process that applies to a wide variety of products and one which manufacturers located in the EU or importers of goods into the EU must complete. The CE mark is affixed to the product as the final stage of this process and is effectively a statement from the manufacturer (or importer) that the process has been successfully completed and that the product meets the essential requirements of the relevant CE marking Directives.
Most of them! If the product falls within the scope of at least one of the CE marking directives and is not specifically excluded, it must be CE marked. Because the directives cover such a large range of products it is not practical (or possible!) to write a list of all the included and excluded products here. However, if you follow the flowchart below you should get an understanding of the directives you need to be dealing with. Once you have identified the ones of interest, you can find out more about them on our detailed directives pages. The flowchart below illustrates the main safety directives. Click to view or download the flowchart as a PDF file with clickable links to more detailed information.
If the product falls under at least one of the CE marking directives, yes. The penalties for not correctly CE marking a product, falsely CE marking a product or failing to CE mark a product for which it is required are generally a maximum of 3 months in jail and a £5000 fine (for the director of the offending company).
Basically, designing a product to meet the relevant standards, creating a Technical File and producing a Declaration of Conformity. What you really need to do is to demonstrate that you have fulfilled the essential requirements of any relevant directives. These are in two parts; Protection requirements and Administrative requirements. The protection requirements relate to the design of the product and can be demonstrated by meeting the requirements of the relevant harmonised standards. The administrative requirements relate to how the product is CE marked. This generally involves the manufacturer producing a Declaration of Conformity and a technical file containing design/manufacturing information and also the application of the CE mark to the product. The flowchart below outlines the basic steps of the process. Click image to see full size:
The vast majority of Europe requires the CE Mark for any product being sold in the country. At current, CE Marking is required to sell in the 28 member states of the European Economic Area, plus Iceland, Norway, Liechtenstein, Switzerland, and Turkey. In addition to these European interests, CE testing is accepted and used by many other countries (for example the FDA requires IEC 60601-1-2 testing for 510(K) medical device submissions).
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