# CE Technical File Author

> Guided elaboration of CE technical documentation and Declaration of Conformity (DoC): applicable directives/regulations (e.g. RED, LVD, EMC, MDR, IVDR, Machinery), risk assessment, essential requirements checklist, and DoC content per product.



Tags: CE Marking, EU, Compliance, Technical Documentation, Declaration of Conformity


## Example Prompts

- Draft our CE technical file for RED and LVD
- Complete essential requirements and risk assessment for MDR
- Draft the Declaration of Conformity for our product
- Check that technical file has required annexes and DoC references

URL: https://rakenne.app/skills/ce-technical-file-author/index.md

Try this skill: https://rakenne.app/a/?skill=ce-technical-file-author



## Overview

Guided elaboration of CE technical documentation and Declaration of Conformity (DoC): applicable directives/regulations (e.g. RED, LVD, EMC, MDR, IVDR, Machinery), risk assessment, essential requirements checklist, and DoC content per product.

## Getting Started

Add your source materials to the project workspace, then activate the *CE Technical File Author* skill. The agent will guide you through the process step by step.

## Example Conversation

> **You:** We need a CE technical file for our radio module (RED) and low-voltage power supply (LVD). Plus the DoC.
>
> **Agent:** I'll create the technical documentation with annexes for RED 2014/53 and LVD 2014/35: product description, risk assessment, essential requirements checklist, and test references. Then the Declaration of Conformity referencing both directives and applied standards.
>
> **You:** Run the validator.
>
> **Agent:** I ran `check_ce_technical_file_annex_coverage`. Annex structure and DoC with legislation references present. No warnings.

## Sample Output Excerpt

**Annex II** — Product description and intended use. **Annex III** — Risk assessment (RED Article 3). **Declaration of Conformity** — We declare that Product X is in conformity with RED 2014/53/EU, LVD 2014/35/EU. Standards: EN 301 489-1, EN 62368-1.

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## Built-in Validation Tools

**check_ce_technical_file_annex_coverage** checks for: technical file/annex structure per directive, and DoC reference to applicable legislation (RED, LVD, MDR, etc.). Run on technical file or DoC after drafting.


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