CE marking requires a series of detailed application documents and technical documentation to demonstrate that your products comply with European regulations and standards. Here are some of the documents that usually need to be prepared:
Technical file: This is one of the most critical documents for CE certification, including the technical specifications, design and performance characteristics of the product, instructions for use, risk assessment, test and test results, manufacturing process, etc. The document should describe in detail the design and production process of the product to ensure compliance with the relevant European standards.
Risk Assessment: A detailed risk assessment is required, including identifying and assessing any hazards that may arise from the product and describing the extent to which the controls are in place to reduce those risks.
Declaration of Conformity: The manufacturer or consignor is required to provide a declaration of conformity confirming that the product complies with applicable European regulations and standards. This is a statutory document that shows that you are willing to take legal responsibility to ensure that the product complies with the regulations.
Test Reports and Certificates: Provide detailed reports and certificates of all tests passed by the product to prove that the product complies with the relevant European standards. This may include electromagnetic compatibility testing, safety performance testing, and more.
Manufacturing Process and Quality Management Documentation: Provide manufacturing process and quality management documentation for products to ensure that products can maintain compliance during the production process.
Technical Specifications and Design Documents: Include the technical specifications and design documents of the product to demonstrate the design and manufacturing process of the product.
User Manuals and Labels: Provide clear, easy-to-understand user manuals to ensure that users can use the product correctly and safely. At the same time, the label on the product also needs to comply with the requirements of CE marking.