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CE Marking Information: CE Marking – Made Easy

Where does it apply?

The following countries accept the CE mark for product certification. The list includes the original 15 European Union (EU) countries, all new members of the EU and the European Free Trade Association (EFTA).

Why should we do it?

One of the primary reasons for obtaining a CE marking for your product is to have access to the European Union Market. This market is made up of 25 plus countries with a population of over 430 Million people. The EU currently is the largest market for computers and office equipment and the second largest (behind the US) in Telecommunications and Consumer Electronics. In addition, the EU is a net importer of electronics, with over half of the imports coming from the US or Japan.

The relatively weak dollar has made US goods very attractive in the EU. The dollar has fallen roughly 30% in the since 2003. If you were competing against a European manufacturer in 2003 when both products cost $1, your product would now be priced approximately 30% less.

In order to have access to the this market, many products are required by law to be in conformance with the CE standards and directives. See the following link: Council Decision 93/465/EEC (Official Journal of the European Union, L 220 of 1993, p. 23)

European National authorities have been charged with enforcement. For example, the Department of Health, or the Department of Industry and Labor at the member countries would be responsible for enforcement. This could be done in a variety of ways, including random checks. The penalties for non-compliance vary from country to country. They could include fines, removal of equipment from the market place (at the manufacturer’s expense), or even imprisonment.

Finally, most of the CE standards that apply to products are harmonized. This means that entry into this market only requires conformance to a single set of standards. Prior to the CE marking directives, each country in Europe had their own set of national standards that could be applicable to products. This significantly increased the costs of ensuring that your product was compliant.

What is it?

The symbol      stands for “Conformité Européenne” which is French for “European Conformity”. When the symbol is affixed to a product it is the manufacturer’s declaration that the product conforms to the essential requirements of all European directives. The essential requirements would include Safety, public health, Electromagnetic Compatibility, and consumer protection, among other things.

CE marking is a mandatory requirement for selling all products that it applies to into EU Countries. It implies that the product has been subject to all applicable evaluation and assessment procedure(s) as defined by the CE directives. CE marking is not a quality symbol. It only indicates that the product conforms to the directives set forth by the EU. It is not an indicator of the overall quality of the product.

The CE conformity marking must consist of the initials “CE”. Where the directive concerned does not impose specific dimensions, the CE marking must have a height of at least 5 mm. The CE marking must be affixed to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents. The CE marking must be affixed visibly, legibly and indelibly.

What is the process for obtaining a CE mark?

For most products, the manufacturer has the obligation to ensure that a product intended to be placed on the EU Community market is designed and manufactured, and its conformity assessed, to the essential requirements in accordance with the provisions of the applicable “New approach” directives. A list of the new approach standards and directives can be found at: http://www.newapproach.org/Directives/DirectiveList.asp.

This “self certification” process puts the responsibility for compliance on the manufacturers selling the product into the EU. The manufacturer has several choices in assessing their products compliance.

The manufacturer can choose to perform the evaluation and assessment themselves. In this scenario, the manufacturer must identify all applicable standards and directives, research and interpret the standards, evaluate the product using the appropriate testing methodology, apply all applicable tests, and create a test report and declaration of conformity to document the assessment procedure.

Alternatively, the manufacturer can sub-contract the assessment and evaluation to a testlaboratory specializing in European conformity. The test lab typically has the appropriate standards and directives, has the expertise to interpret the standards for the manufacturer’s product, understands the testing methodology necessary and has experience in creating test reports and assist in the creation of a Declarations of Conformity that appropriately documents the assessment process.

Some products require an evaluation by a Notified Body. Examples of these types of products would include: many medical devices, some radio transmitters, products intended to operate in explosive atmospheres, etc. In these cases, the manufacturer is required to provide all product documentation, including assessment information to the notified body prior to placing the product on the market. In practice, the manufacturer of those types of products should work closely with the notified body to make sure their assessment documentation is in order.