Basically, the Technical File comprises:
- A general description of the product;
- Sometimes a risk assessment to determine which safety and health requirements apply to the product;
- Design and production drawings;
- Detailed technical drawings about the essential aspects of the product;
- A list with the essential health and safety requirements that were met;
- Report of performed calculations and tests;
- Certificates and inspection reports;
- User’s manual;
- For series production, the internal stipulations that were complied with to guarantee conformity with the Directive(s)
