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| | | CE marking is the visual symbol, printed on products placed on the market, signifying that the product meets the essential safety requirements of a “New Approach” directive. It is therefore a passport allowing free movement of the product throughout the territory of the European Union. |
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| WHAT IS A HARMONISED (EN) EUROPEAN STANDARD? |
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| | | Within the framework of the "New Approach", a harmonized EN translates essential safety requirements outlined in directives into technical instructions. In some ways it is a technical specification which provides manufacturers with “how to” information. Although their application is voluntary, compliance with a harmonized European standard confers a presumption of conformity to the basic safety requirements laid down in the relevant directive. These European standards are only said to be harmonized once they have appeared in the Official Journal of the European Communities (OJEC). |
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| CAN A PRODUCT BE COVERED BY SEVERAL “NEW APPROACH” DIRECTIVES? |
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| | YES. A single product may give rise to different risks. Example: a mains-powered electronically-controlled machine is covered by the “machine” directive in terms of mechanical hazards, by the “electromagnetic compatibility” directive in terms of the risk of electromagnetic disturbance it might cause or which might affect it, and by the “low voltage” directive in terms of its electrical hazards.
Another example - a mains-powered medical diagnostic device is covered:
•by the “medical devices” directive in terms of the risks to which patients or medical personnel are exposed when it is in use,
•the “electromagnetic compatibility” directive in terms of the electromagnetic disturbance it might cause or which might affect it.
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| WILL A PRODUCT COVERED BY SEVERAL DIRECTIVES HAVE SEVERAL CE MARKINGS? |
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| | | NO. By means of a single CE marking the manufacturer or person responsible for first placing the product on the market certifies conformity to the essential safety requirements of the various directives which apply to the product concerned. However, the directives to which a product conforms must be specified and quoted on the declaration(s) of conformity by the manufacturer or his agent, who must also prepare supporting documentation for this marking (production documents, technical documents, etc) for each directive concerned. |
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| WHAT IF THERE IS NO STANDARD FOR MY PRODUCT, OR THE EXISTING STANDARD IS NOT ADAPTED TO MY PRODUCT? |
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| | | This problem can arise in the case of customised products. The manufacturer can then establish his own frame of reference, a set of in-house technical specifications or “good manufacturing practices”. These must sometimes be validated (eg: EMC directive) through the intervention of a competent organisation. |
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| SO TO FULFIL MY OBLIGATIONS AND APPLY CE MARKING, I SIMPLY HAVE TO COMPLY WITH THE HARMONISED STANDARDS OR ANOTHER FRAME OF REFERENCE? |
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| | | Be careful not to confuse results with the means of achieving them. Under the terms of the directives, your products must meet essential health and safety requirements and you must certify this conformity, or arrange for certification to be provided. The application of standards, even harmonised standards, is never compulsory. However, compliance with them presumes that your products meet the essential safety requirements outlined in the directives. |
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| WHAT IS THE DECLARATION OF CONFORMITY? |
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| | | The declaration of conformity is the document by which the manufacturer attests that his product meets the “essential health and safety requirements” of the regulations affecting it and thus is the document through which he accepts liability. He is always required to produce one, even if he used a test laboratory. |
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