Purpose
The decision establishes a uniform framework for conformity assessment procedures for products under European harmonisation directives. Its main objectives are to ensure product safety, health protection, and environmental protection, while enabling the free movement of products within the EU single market through the CE marking, which certifies that the product complies with EU standards.
Scope of application
It applies to all EU technical harmonisation directives requiring conformity assessment and CE marking. This includes industrial products, machinery, electrical equipment, safety devices, and any goods that must meet essential safety, health, and environmental requirements under specific directives to be placed on the EU market.
Main features and mechanisms
The decision introduces standardized modules for conformity assessment, covering all stages of a product’s life cycle, from design and manufacturing to final inspection. It defines the responsibilities of manufacturers, suppliers, and notified bodies, specifying procedures for certification, technical documentation, and necessary testing. It also regulates the affixing of the CE marking, which represents the manufacturer’s declaration of compliance with all applicable requirements. Additionally, it establishes oversight and monitoring mechanisms by national authorities and tools to ensure traceability of products in the European market, reducing the risk of non-compliant or unsafe products.