CEmarkeringprocessen

CE marking is a self-declaration by a manufacturer that a product meets the essential requirements of the relevant European Union directives and regulations. This process is crucial for placing products on the European Economic Area (EEA) market. The CE mark signifies that the product conforms to EU legislation regarding health, safety, and environmental protection.

The CE marking process typically involves several steps. First, the manufacturer must identify all applicable EU directives and regulations for their specific product. These directives outline the essential requirements that the product must satisfy. Next, the manufacturer must conduct a conformity assessment. This assessment verifies that the product meets these essential requirements. Depending on the product's risk level, this assessment may involve self-assessment by the manufacturer or require the involvement of a Notified Body, an independent organization designated by an EU country to assess product conformity.

Once conformity is established, the manufacturer compiles a technical file containing all relevant documentation, including design specifications, risk assessments, test reports, and the declaration of conformity. The manufacturer then affixes the CE mark to the product, its packaging, or accompanying documents. This declaration is a legal commitment by the manufacturer. Finally, the manufacturer keeps the technical documentation available for inspection by market surveillance authorities in the EU member states. This ensures ongoing compliance and accountability.