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The CE marking indicates compliance with fundamental health and safety requirements for European Directive 89/686.
The directive divides PPE into three categories, each subject to a different conformity evaluation system:
• Category 1: the manufacturer drafts a technical file and affixes the CE marking without the intervention of an external notified body.
• Category 2: the manufacturer affixes the CE marking after the notified body has performed a type examination on the basis of a technical file.
• Category 3: after the type examination, a notified body conducts a periodic inspection. Manufacturers decide whether the inspection system focuses on product sampling or on an audit of the quality system. Following inspection, the CE marking and the number of the notified body that conducted the inspection must be affixed to the product.
The European Commission describes the CE marking as a "passport" that allows manufacturers to circulate industrial products freely within the internal market of the EU. The CE marking certifies that products have met EU health, safety, and environmental requirements that ensure consumer and workplace safety. All manufacturers in the EU and abroad must affix the CE marking to products covered by the "New Approach" directives to market their products in Europe. Once a product receives a CE marking, it can be marketed throughout the EU without modification.
Most products covered by New Approach Directives can be self-certified by the manufacturer and do not require review by EU-authorized independent testing/certifying companies (i.e., Notified Bodies). To self-certify, the manufacturer must assess the conformity of the products with applicable directives and standards. While the use of EU harmonized standards is voluntary, in practice the use of EU standards is the best way to meet the requirements of the CE marking directives. This is because the standards offer specific guidelines and tests to meet safety requirements, while the directives, general in nature, do not.
The manufacturer may affix the CE marking to their products following the preparation of a declaration of conformity, which indicates that the product meets applicable requirements. Manufacturers must maintain a technical file to prove conformity and they, or their authorized representatives, must provide this together with the declaration of conformity when requested by EU authorities.
If a directive requires the involvement of a Notified Body in the conformity assessment procedure, its identification number must be displayed behind the CE logo. Doing this is the responsibility of the Notified Body.
CE marking is mandatory for certain product groups within the European Economic Area (EEA; the 28 member states of the EU plus EFTA countries Iceland, Norway, and Liechtenstein) plus Switzerland and Turkey. The manufacturer of products made within the EEA and the importer of goods made in other countries must ensure that CE-marked goods conform to all applicable standards.
By affixing the CE marking on a product, a manufacturer is declaring, at its sole responsibility, conformity with all of the legal requirements to achieve CE marking that will permit the free movement and sale of the product throughout the EEA.