Sample CE Technical File for Product CE Mark Certification
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- Product Description and Intended Use: This section provides a detailed overview of the product, its specifications, and its intended application. It should include models, types, serial numbers, and relevant pictures.
- Design and Manufacturing Documentation: This part includes comprehensive information on the product’s design, such as mechanical drawings, exploded views, bill of materials (BOM), and descriptions of manufacturing processes and quality control procedures.
- Risk Assessment and Applied Standards: A thorough risk assessment identifies potential hazards and how they are mitigated. This section also details the harmonized standards and specifications applied during the product’s design and testing.
- Verification, Validation, and User Information: This includes reports from tests, calculations, and inspections that verify conformity. It also covers essential user information like manuals, labels, warnings, and clear instructions for safe use.