The CE marking is the manufacturer’s declaration that a product meets the requirements of the applicable EC directives (formerly referred to as “New Approach Directives”).
The first step in the process is to identify whether the product needs to bear CE mark or not. Only the products that fall within the scope of at least one of the 20+ EC directives require the CE mark. The following are some of the more prominent directives:
Identifying which directive(s) are applicable to a product requires someone (preferably with a technical background) to review the scope of each directive, and establish which apply to the product in question. If the product does not fall within the scope of any of the directives, the product is not required to bear the CE mark, and in fact is precluded from bearing the CE marking. Please refer to the EC database for an up-to-date, complete list of the EC Directives.
Each Directive has slightly different methods of demonstrating conformity, depending on the classification of the product and its intended use. Every Directive also has a number of ‘essential requirements’ that the product must meet before being placed on the market.
The best way to demonstrate these essential requirements have been met is by meeting the requirements of an applicable ‘harmonized standard,’ which offer a presumption of conformity to the essential requirements, although the use of standards usually remains voluntary. Harmonized standards can be identified by searching the ‘Official Journal’ on the European Commission’s website, or by visiting the New Approach website established by the European Commission and EFTA with the European Standardization Organizations.
The format of the mark is regulated. The letters “CE” are drawn from two circles, laid out according to Figure 1. The vertical size may not be less than 5 mm. Normally, the mark will be placed in a visible spot on the outside of the equipment, but in cases where that is impractical, it may be included on the packaging and/or documentation.
It is important to note, that in addition to the mark itself, some Directives require that additional information accompany the mark or the Declaration of Conformity. Depending on the quality assurance module chosen, you may also need to include the identification number of the notified body responsible for EC surveillance of the quality system.
New Recast Directives also now require the manufacturer to mark their address on the product itself unless space is not available.
The new Low Voltage Directive (2014/35/EU) now requires a risk assessment be conducted on equipment. This directive does not require that the mark be accompanied by any additional information. However, the declaration of conformity must include the following items:
Contact G&M Compliance today to get a quote or learn more about the requirements of the CE Mark.