Six steps to CE marking for goods sold within the EU
What is the CE mark?
The CE mark is a symbol that a manufacturer (see definition below) affixes to a product so that it can be sold in Europe. The mark is mandatory for products which fall under one of 24 European directives. The CE mark means that the manufacturer takes responsibility for the compliance of a product with all applicable European health, safety, performance and environmental requirements. CE stands for "Conformité Européenne", the French for European conformity.
The mark is required in all 27 member states of the EU, as well as Iceland, Norway, and Liechtenstein. Switzerland accepts the CE mark for some products and Türkiye actually requires that many products be CE marked.
Definition of manufacturer:
The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under its own name.
The bottom line: CE marking provides access to a market of over 500 million consumers.
CE is not like other certification marks.
The Canadian Standards Association (CSA) or the Underwriters' Laboratories (UL) marks, for example, can only be used when those organizations have determined that a product meets applicable standards. European organizations do not grant authorization to use the CE mark as it is not owned by any particular body. The manufacturer is responsible for its proper use.
The manufacturer, whether established inside or outside the EU, is ultimately responsible for affixing the CE mark and is also responsible for its proper use. The manufacturer established outside the EU may appoint an authorized representative established in the EU to act on his behalf. CE marking is about more than affixing a symbol to a product.
The following six steps bring together insight on CE marking from experts and Trade Commissioners alike, as well as key EU resources:
- Find the CE directive(s) that applies to your product
- Know the essential requirements for your product
- Determine if you need third-party certification
- Assess product conformity
- Create and maintain technical documentation
- Declaration of conformity & affixing the CE Mark
Please note: this guide is not comprehensive and companies are strongly encouraged to consult the web resources section for additional information.