CEmärgisele

CEmärgisele is the Estonian term for the CE marking, a certification mark indicating conformity with EU safety, health, and environmental protection requirements for products marketed in the European Economic Area (EEA). The mark signals that a product complies with applicable EU directives or regulations and can be sold freely within the internal market. It is not a quality guarantee or approval by a European authority, but a declaration of conformity made by the manufacturer or its authorized representative.

Scope and directives: The requirement applies to products within scope of harmonised EU directives or regulations. Manufacturers identify which directives apply, reference harmonised standards, and perform or commission conformity assessment. Depending on risk, this may involve self-declaration or independent assessment by a Notified Body. The resulting technical documentation and the EU Declaration of Conformity form the evidence of compliance; the documentation must be kept for a set period, typically 10 years after the product is placed on the market.

Affixing the mark: Once conformity is established, the CE mark is affixed to the product or its packaging, along with any required identifying numbers (for Notified Bodies) and user instructions in appropriate languages. The importer and distributor have responsibilities to ensure proper labeling and traceability.

Limitations and scope: CE marking covers market access in the EU/EEA and does not by itself ensure performance or quality beyond compliance; it does not guarantee safety in all situations and does not indicate compliance with third-country requirements outside the EU.

Examples: Common product groups include machinery, electrical equipment, toys, PPE, medical devices, construction products, and many others. The system relies on harmonised standards, but compliance can also be shown by other technical specifications when aligned with directives.