How can I be certain that I carried out the certifiction correctly?
Products that are manufactured and tested according to harmonizedstandards, are presumed to be in compliance with the essential requirements of the applicable directive that refer to this standard.
In addition, the following principles shall be carried out when CE Marking take place by Self Certification:
– The manufacturer, his authorized representative or the importer (economic operator) must ensure and declare that the products meet the essential requirements of directives applicable to them;
– The economic operator shall, on each product affix the CE-marking and draw up the EC declaration of conformity;
– The economic operator shall establish the technical documentation (Technical File) and keep it for at least ten years after the last product available for inspection by the competent national authorities;
– Based on the Technical File 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) that are applicable on the product.
- CE Marking
- Certification Experts
- Authorized Representative
- CE Declaration of Conformity
- Competent Body (Notified Body)
- Technical File
- Information on the Product
- USA compliance
- Self certification
- Export to China
- Summary Directives
- Medical Devices