What is a CE Mark?

CE marking involves awarding a firm/organization a certification mark to indicate that it is conformity with environmental protection, health, and safety standards for traded products within the European Economic Area (EEA). CE marking is also applicable to other countries outside the EEA which are manufactured, designed, or sold in the EEA. As a result, CE marketing has been recognized across the globe even among people who are not familiar with EEA. The regulation is used in similar sense as the FCC Declaration of Conformity in the US which restricts certain electronic devices.

How is a CE Mark Used?

CE marking is the declaration of a manufacturer that the products manufactured or sold are meeting the EC directives requirements. A CE logo characterizes the mark with four-digit identification number of the Notified Body that conducted the conformity assessment. Originated in 1985, CE is the abbreviation of Conformit Europenne, which means European Conformity. However, CE has not been defined as the abbreviated teem in the relevant legislation. The mark is the free marketability symbol in the European Economic Area. 

Countries that require CE marking 

CE marking is a mandatory process for all product manufacturers or sellers within the EAA, which includes 28 member states of the European Union and EFTA countries such as Iceland, Liechtenstein, and Norway as well as Switzerland and Turkey. Other groups to comply with CE marking include importers of goods from other countries. As of 2013, CE marking was not a mandatory requirement for member states of the Central European Free Trade Agreement (CEFTA). The members included were Serbia, the Republic of Macedonia, and Montenegro which has applied for the EU membership and were adopting several standards within the CEFTA legislations.

Rules underlying CE Marks

The role of CE marking lies with the parties or companies that put products in the EU market, i.e., manufacturers based in the EU, importers, and distributors of products outside the EU, and non-EU manufacturers whose offices are based in the EU. Although product manufacturers affix the CE marking on products, there are certain obligatory steps that must be taken. The manufacturer must go through a conformity assessment which entails setting up a technical file and signing a Declaration that is stipulated by the leading product legislation. The documentation is made available to CE marking authorities upon request. Product imports must also verify that the non-EU manufacturer has undertaken the necessary steps and that documentation will be available upon request. The law also requires importers to ensure that contact with the manufacturer can easily be established. Also, distributors should be able to demonstrate that they have taken the necessary steps in line with CE marking regulations and must have affirmation from the importer or manufacturer that all the legal requirements have been met. In case importers and distributors are marketing products under their name, it means that they have undertaken the responsibility of the manufacturer. In such a situation, they need to have sufficient information on the production and design of the product since they are taking legal responsibility when affixing CE marking. The key rules that underlie the procedure of affixing CE marking include:

• Products that are subject to EU regulations or directives have to be affixed with CE marking before taken to the market.
• It is mandatory for manufacturers to check which EU legislation is needed to apply for a particular product.
• A product may be placed in the market only when it complies with the applicable regulations and only after undertaking the conformity assessment procedure.
• It is the responsibility of the manufacturer to draw up EU conformity declaration or performance declaration and affixes the CE marking on the promoted products.
• EU directives and regulations stipulate that any authorized third party must be involved in the procedure of conformity assessment or in setting up a production quality system.
• If a product has been affixed with CE marking, it can bear additional markings if they have different significance. It is required that the markings do overlap with the CE marking so as not to impair the visibility and legibility of the CE marking.

The first guide intended to provide a clear CE marking directive based on the Global Approach was published in 2000 by the EU. The version was updated on 2014 February and 2016 July.