DEFINITION
Conformity assessment is the procedure used to demonstrate that a product meets the relevant requirements. The EU utilises standardised modules, ranging from internal production control procedures to quality assurance systems and type examinations.
DeclarationConformity assessment
The applicable assessment module is determined by the respective legislative act and the product's risk profile; where applicable, a notified body must be involved. Results must be documented in the technical documentation and declared in the EU declaration of conformity.
Practical application: Early selection of modules and standards, test planning, and the involvement of the notified body accelerate market entry. Any design modifications necessitate a reassessment of conformity.
Key Points
- Module-dependent (ranging from internal production control to a notified body).
- Results to be documented in the Technical Documentation and DoC.
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