Step-by-Step: How to Create a Technical File
1. Product Identification
Product name, model number, and variants
Clear product photos
Description of intended use and function
2. Applicable Regulations & Directives
EU Directives (e.g. Toy Safety Directive, EMC, RoHS, etc.)
UK equivalents for UKCA
GPSR (General Product Safety Regulation) for general safety
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3. Risk Assessment
Identify potential hazards (electrical, chemical, mechanical, etc.)
Describe risk mitigation and safety controls
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4. Bill of Materials (BoM)
List of all components and raw materials
Include material composition and part numbers
5. Technical Drawings / Product Design
Schematics, diagrams, circuit layouts (if applicable)
Description of design, function, and safety features
6. Test Reports & Certificates
Third-party lab reports (e.g., EN 71, EN 60335, EN 55032)
CE or UKCA test results proving safety and compliance
7. Conformity Assessment Method
Describe the self-assessment route or involvement of a Notified Body
Include certificate numbers if applicable
8. Labels & User Instructions
CE or UKCA label example with warnings and identification
User manual with safety instructions and language requirements for each market
9. Declaration of Conformity
Signed document (EU and/or UKCA)
Must reference directives, standards, and responsible person info
10. Quality Control & Manufacturing Info
Description of your manufacturing process
Factory audit, traceability, and QC procedures (if available)
📁 File Format & Storage
Recommended formats: PDF, Word, Excel
Keep all sections organized and up to date
Store securely for at least 10 years
🧾 Need Help Creating Your Technical File?
If you need:
Technical File Checklist
Risk Assessment Templates
👉 Visit: https://shop.euverify.com
We offer ready-made templates across many product categories.