Overensstemmelsesvurdering

Overensstemmelsesvurdering refers to the process of demonstrating that a product, service, process, or system conforms to specified requirements. This is a critical step in ensuring quality, safety, and compliance with relevant regulations and standards. The term is often used in the context of European Union directives and regulations, where it signifies the procedure by which a manufacturer or importer proves that their product meets the essential requirements set out in the applicable legislation.

There are various methods of conformity assessment, depending on the product and the associated risks. These can include self-assessment by the manufacturer, where they declare conformity based on their own internal checks and documentation. Alternatively, for higher-risk products, third-party involvement is often required. This typically involves a Notified Body, an independent organization designated by an EU member state to carry out conformity assessment.

The goal of overensstemmelsesvurdering is to build confidence among consumers, authorities, and other stakeholders that the item in question is safe, performs as intended, and adheres to legal obligations. Successful completion of the conformity assessment often leads to the affixing of a CE marking on products within the European Economic Area, indicating that the product complies with all relevant EU legislation and can be traded freely within the EU. The specific procedures are detailed in EU directives and regulations specific to different product categories.