- The manufacturer, his authorized representative or the importer (economic operator) must ensure and declare that the products meet the essential requirements of applicable directives;
- The economic operator shall establish the technical documentation (Technical File) and keep it for at least ten years after the last product is available for inspection by the competent national authorities
- Based on the TF, the economic operator must be able to demonstrate whether the product complies with the essential requirements of the applicable directive (s). When applicable, the Technical File also covers the design, manufacture and operation of the product
- The economic operator shall take all necessary measures, to ensure that the products are manufactured in accordance with manufacturing process as drawn up in the Technical File and with the essential requirements of the Directive (s) related to the product.
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