The CE mark indicates compliance with the essential health and safety requirements according to European Directive 89/686.
The directive divides personal protective equipment (PPE) into three categories, each subject to a conformity assessment system:

Category 1: The manufacturer prepares the technical documentation and affixes the CE mark without the intervention of a notified (external) body.

Category 2: The manufacturer affixes the CE mark after an external notified body has carried out a type examination based on the technical documentation.

Category 3: After the type examination, the notified body performs periodic inspections. Manufacturers can decide whether the assessment system will focus on product sampling or quality system audits. After the inspection, the product must display the CE mark along with the identification number of the notified body that conducted the assessment.

The European Commission describes the CE mark as a kind of “passport” that allows manufacturers to freely circulate industrial products within the EU market. The CE mark confirms that products meet EU health, safety, and environmental requirements, ensuring the safety of consumers and workplaces. All manufacturers in the EU and abroad must affix the CE mark to products covered by directives in order to place them on the European market. Once a product receives the CE mark, it can be marketed throughout the EU without modifications.

Most products covered by the directives can be self-certified by the manufacturer and do not require inspection by independent EU-authorized testing/certification bodies (i.e., notified bodies). For self-certification, the manufacturer must assess the product’s compliance with the applicable directives and standards. While using EU harmonized standards is voluntary, in practice, applying these standards is the best way to meet the CE marking requirements. This is because the standards provide specific guidelines and tests to satisfy safety requirements, whereas the directives themselves are general.

The manufacturer can affix the CE mark to their products after preparing a declaration of conformity, which shows that the product meets applicable requirements. Manufacturers must maintain a technical file to demonstrate compliance, and they—or their authorized representatives—must provide it along with the declaration of conformity if requested by EU authorities.

If a directive requires the involvement of a notified body in the conformity assessment process, its identification number must be displayed next to the CE logo. This is the responsibility of the notified body.

The CE mark is mandatory for certain product groups within the European Economic Area (EEA; 28 EU member states plus EFTA countries Iceland, Norway, and Liechtenstein), as well as Switzerland and Turkey. The manufacturer of products produced within the EEA and the importer of goods produced in other countries must ensure that products with the CE mark comply with all applicable standards.

By affixing the CE mark to a product, the manufacturer declares, on their sole responsibility, compliance with all legal requirements necessary to obtain the CE mark, which enables free movement and sale of the product throughout the EEA.

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