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The process possibly adding to the confusion is that, for some products, a company can register itself for the BSI CE marking. If a product has a low safety risk or none at all, the manufacturer can obtain and apply the CE marking on its own. It's important to consult the directives to determine whether this is an option for your company. To date, if your product falls under one or more of the following directives, you cannot self-certify:
* Low-voltage electrical safety (73/23/EEC)
* Simple pressure vessels (87/404/EEC)
* Toys (87/378/EEC)
* Construction products (89/106/EEC)
* Electromagnetic compatibility (89/336/EEC)
* Machine safety (89/392/EEC)
* Personal protective equipment (89/686/EEC)
* Non-automatic weighing machines (90/384/EEC)
* Active implantable medical devices (90/385/EEC)
* Gas appliances (90/396/EEC)
* Telecommunications terminal equipment (91/263/EEC)
* Water boilers (92/42/EEC)
* Explosives for civil uses (93/15/EEC)
* Medical devices (93/42/EEC)
* Equipment for explosive atmospheres (94/9/EEC)
* Recreational craft (94/25/EEC)
* Passenger lifts (95/16/EEC)
* General pressure equipment (97/23/EEC)
* Energy efficiency of household appliances
Another factor adding to the confusion is that every day, the European Commission is considering new directives. Keeping yourself informed becomes a major factor in whether you successfully obtain and maintain the CE marking.
Companies that wish to affix the CE marking to products governed by directives must get the help of a notified body, which is an organization appointed by the EU to audit products and quality systems under the directives. Many ISO registrars in the United States also specialize in the CE-marking process, so a company should have no problem finding help. It is important, though, to find a notified body that is familiar with and specializes in your particular industry. Any notified body will be willing to approve a product for the CE marking, but since registration will decide whether the product can be sold overseas, it's important not to choose just any notified body. (See "Do it right the first time," above)
Once approved, a notified body will then run a risk assessment of your product, determining to which directives the product must comply and what potential safety risks it poses. Then the manufacturer and notified body work together on possible solutions to make the product compliant. The design changes are made-whether it is with the addition of a guardrail to a milling machine or making a puzzle piece larger-and then thoroughly documented. Throughout this whole process, a technical file is compiled. It contains such information as the risk assessment, test results, product drawings, operating instructions, and the declaration of conformity, which states which directives and standards the product complies with. Once a company creates this and completes a successful audit, it can affix the BSI CE marking to its product.
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