In accordance with the requirements of European directives or regulations, manufacturers should draw up a declaration of conformity and have sole responsibility for the conformity of products marketed with the CE marking. Therefore, before placing a product on the European market, the manufacturer needs to assess and select the applicable directive or regulation and the compliance path to ensure that the product complies with the requirements of the directive or regulation, establish and implement a quality management system QMS (if applicable), Prepare the Technical Documentation or Design Dossier for the CE mark and affix the CE mark.
If the manufacturer does not have a physical location in Europe, it is necessary to appoint a European authorized representative to perform the specific duties required of the manufacturer by the relevant EU directives and laws.