CE marking stands for 'Conformité Européene' which literally means 'European Conformity'. It is a legal requirement allowing free trade of manufactured goods within the EU/EEA. It is a mandatory certification scheme in all EU member states and Norway, Iceland, and Liechtenstein. It is also required for products placed on the markets in Switzerland and Turkey.
CE marking signifies that a product:
- complies with the minimum health, safety and environmental requirements of all applicable EU directives
- fulfils the provisions of the relevant EU harmonised standards
- is fit for its purpose and will not put in danger people's lives or property.
The presence of CE marking on a product further indicates that appropriate technical documentation supporting its use is available and, upon request, can be provided to the market surveillance authorities. However, it doesn't indicate the product's origin or that the product has been approved as safe by the European Union or another authority.
To bear the CE marking symbol, products must fall within the scope of at least one of the EU directives and regulations. In this regard, the CE marking sign is mandatory for all:
- Newly developed products, regardless of their place of manufacture, as long as they are made available to EU consumers.
- Used or second-hand goods imported from countries outside the EU/EEA.
- Significantly modified products that fall within the scope of the CE directives as new products.
Custom-made goods or products intended for clinical investigations do not need to be CE marked.