Common to them is that they belong under one of the directives for which the European Union has adopted CE marking. Each product directive covers a number of product groups; for example, lifting gear and appliances is a product group under the Machinery Directive. The product groups in the directives have been selected to focus particularly on safety, health and the environment.
Only products marketed or put into use in the EU are to be CE marked.
Basically, it is the manufacturer who has to CE mark. However, when a finished product is ready to be placed on the market, several parties may be involved, e.g. manufacturer, importer or distributor. In the case of CE marking, the ultimate responsibility lies with those who place the product on the market.
CE marking shall be carried out by all who launch a product on the market in EU Member States and the EFTA countries Iceland, Liechtenstein, Switzerland and Norway, which are covered by the EEA Agreement. Although a product is exclusively manufactured and marketed in Denmark, it nevertheless has to be CE marked.
The CE mark is part of the EU's wish to create free movement of goods between EU countries. When identical requirements are imposed on products through legislation, technical barriers to trade are reduced. This also ensures that national authorities in a single EU country cannot impose stricter requirements on a product than those set out in the directive.
The CE mark is a declaration that the product meets the requirements set out in the directives and standards. Hence, the CE mark is not a quality label. However, the requirements of the legislation are based on environmental concerns and consumer safety and health. Here it is important to note that CE marking does not in all cases mean that the product has been tested. For some products, testing is not required, whereas other products, such as dangerous machines, must be tested by an independent body – a third party. Nor does a CE mark necessarily mean that the product was manufactured within the EU/EFTA.
European standards play a key role in CE marking. This applies, in particular, to so-called harmonized standards, which in brief are standards specifying how a manufacturer can comply with a directive. If a harmonized standard is followed, one has the right to assume that the essential requirements of the legislation are also complied with. This is also called presumption of conformity. In other words, the standards become an aid for the manufacturer to document that he or she complies with the requirements of the legislation.
For most products, these standards are a voluntary tool for use by manufacturers. However, when it comes to e.g. construction products, standards must be used, i.e. using the harmonized standards is mandatory.
Individual EU Member States carry out market surveillance to protect consumers from non-safe products and incorrect use of CE marking. For example, it is checked whether the product is CE marked, whether the product meets the requirements and whether the marking is designed correctly. If the product does not meet the requirements, there are several enforcement measures, such as enforcement notice, fine notice, reporting it to the police, or removing the product from the market. The enforcement measures depend on the legislation to which the product is subject.
There is no simple answer to that question, as this varies depending on the individual product directive. However, there are some steps the manufacturer typically has to go through before the CE mark can be affixed to the product. For example, the directive(s) to which the product is subject shall be taken into account; you have to know what essential requirements the product has to meet and you have to find the standards that can help you meet the requirements.