Short answer
Technical documentation shows how the product was designed, manufactured, and assessed against applicable requirements. It must be complete before the product is placed on the market.
Key takeaways
- Product identification and intended use
- Design, BOM, and critical components
- Applicable requirements and risk assessment
- Standards, calculations, and test reports
- Instructions, marking, and labels
- Signed EU declaration and change history
This content is a practical overview, not legal advice. Always verify the current legislation and the requirements that apply to your product. Research uses official primary sources; competitor content is used only to identify questions and content gaps.
Content depends on the product and legislation
A technical file normally includes product description, drawings, components, risk assessment, essential requirements, standards, calculations, test reports, instructions, marking, and the EU declaration.
Build the file alongside development
Documentation should be versioned from requirements through production release. Every item of evidence should link to the correct product variant, requirement, and decision.
Traceability matters more than document volume
An authority should understand why each item is relevant. Record product version, standard edition, test configuration, deviations, and responsible reviewer.
Documents that do not agree
Typical errors include conflicting model names, old standard editions, reports for another configuration, missing risk controls, and an EU declaration that does not reflect the technical file.
Minimum evidence
- Product identification and intended use
- Design, BOM, and critical components
- Applicable requirements and risk assessment
- Standards, calculations, and test reports
- Instructions, marking, and labels
- Signed EU declaration and change history
Version-controlled documentation workflow
Verca collects documents, metadata, reviews, and signing by product. The customer remains responsible for technically correct and complete evidence for the target market.
Frequently asked questions
What does this mean in practice?
Technical documentation shows how the product was designed, manufactured, and assessed against applicable requirements. It must be complete before the product is placed on the market.
Who is responsible for the work?
A technical file normally includes product description, drawings, components, risk assessment, essential requirements, standards, calculations, test reports, instructions, marking, and the EU declaration.
What documentation is required?
An authority should understand why each item is relevant. Record product version, standard edition, test configuration, deviations, and responsible reviewer.
Official sources
Primary sources used for this guide.