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.

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.