El marcado CE es un proceso de evaluación de la conformidad por el cual el fabricante o su representante autorizado asumen la responsabilidad de las prestaciones declaradas. La organización debe cumplir con los criterios establecidos en las Directivas o Reglamentos Europeos, así como las normas técnicas EN que aplican a la comercialización del producto.
El producto está sujeto a evaluación de la conformidad durante las fases de diseño y producción y, aunque el fabricante subcontrate el diseño o la producción, éste seguirá siendo el responsable de la evaluación de la conformidad del producto.
El fabricante o su representante autorizado debe comprobar si es necesario que el producto sea sometido a ensayos por organismo notificado.
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