CE Marking
CE marking is the result of determining conformity of products with the requirements of the member states of the European Union. Uniform requirements were created to eliminate technical barriers and enable the formation of the European market. This marking confirms product safety both for the end consumer and for the environment. The presence of CE marking indicates compliance with all necessary EU legal requirements for regulatory authorities. CE is not a mark of product quality.
For which products is CE marking mandatory?
CE marking is mandatory only for products covered by the New Approach and Global Approach directives. The design features of the product play an important role.
The presence of individual components with a CE certificate does not entitle a manufacturer to apply the marking to the finished product without completing the official conformity assessment procedure.
- low-voltage equipment;
- machinery and mechanisms;
- construction products;
- medical devices, including in vitro devices;
- personal protective equipment;
- marine equipment and cableways;
- gas appliances;
- radio equipment;
- measuring instruments;
- lifts and safety components;
- non-automatic weighing instruments;
- explosives for civil use;
- watercraft;
- pyrotechnic articles;
- pressure equipment;
- toys;
- water-heating boilers;
- active implantable medical devices.
How to obtain CE marking?
Only after all requirements are fulfilled and the CE marking is applied may the product be placed on the markets of European Union countries.
- determine which directive or directives apply to the product;
- collect information on the applicable conformity assessment procedures;
- identify the applicable European standards;
- verify compliance with EU requirements;
- determine whether a notified body must be involved;
- prepare the technical documentation and market analysis;
- obtain the declaration of conformity;
- apply the CE marking to the product, packaging, and accompanying documentation.
Technical documentation and the EU declaration
Conformity assessment must be supported by technical documentation that demonstrates how the product meets essential requirements of the applicable EU legislation. Depending on the product category, this may include design calculations, test reports, risk assessments, user instructions, and diagrams of safety-relevant components.
The EU declaration of conformity is the manufacturer's formal statement that all applicable requirements have been met. It must be kept available for market surveillance authorities for the period defined in the relevant regulation, typically linked to the product life on the market.
Harmonised standards and notified body involvement
European harmonised standards provide a presumption of conformity when applied correctly; they translate directive essential requirements into measurable technical criteria. Manufacturers choose the most relevant standards for their product design but remain responsible for overall compliance.
For higher-risk categories—such as certain medical devices, pressure equipment, or gas appliances—a notified body may be required to assess the quality system or review technical files before CE marking can be applied. We guide clients through module selection, liaison with notified bodies, and preparation for documentation review.