Download CE Documentation Checklist (PDF)
Everything you need in your CE technical file — before you send it for translation
Use this checklist when preparing CE/UKCA technical documentation for translation into European languages. It covers the documentation requirements under both the current Machinery Directive (2006/42/EC) and the new EU Machinery Regulation (2023/1230), which takes effect 20 January 2027.
Before You Start
CE marking requires that specific documentation exists, is complete, and — for most document types — is available in the official language(s) of every EU member state where your product is placed on the market.
Missing or incomplete documentation doesn’t just delay translation. It delays market access.
This checklist helps you confirm that your technical file is complete and translation-ready.
Technical File Contents
General Requirements
- General description of the machinery — including variants, intended use, and foreseeable misuse
- Overall drawing of the machinery — plus control circuit diagrams and descriptions needed to understand how it works
- Full detailed drawings — with calculations, test results, certificates, and other data required to check conformity with essential health and safety requirements
- Risk assessment documentation — showing the procedure followed, including a list of essential health and safety requirements applicable to the machinery and the protective measures implemented
- Standards applied — list of harmonised standards and/or other technical specifications used, indicating which essential requirements are covered by those standards
- Technical reports — results of tests carried out by the manufacturer or by a body chosen by the manufacturer or their authorised representative
- Copy of the instructions for the machinery — final version, in the original language
- Declaration of Conformity — or, where applicable, Declaration of Incorporation for partly completed machinery
Instructions (User Documentation)
- Business name and full address of the manufacturer and, where applicable, the authorised representative
- Designation of the machinery — as marked on the machinery itself (series, type, model, serial number)
- The EU Declaration of Conformity — or instructions on where to access the digital version (under the new Regulation)
- General description of the machinery — purpose, operation, variants
- Drawings, diagrams, descriptions, and explanations necessary for use, maintenance, and repair
- Description of the intended use — including foreseeable misuse
- Warnings about residual risks — risks that remain despite protective measures taken
- Instructions for installation and assembly — including drawings, diagrams, fastening methods, and designation of vibration characteristics
- Instructions for putting into service and use — including operating procedures and safety instructions
- Training information — where applicable, training needs for operators
- Information about foreseeable misuse — based on experience, and how to prevent it
- Maintenance instructions — type and frequency of inspections, wearing parts, maintenance procedures
- Noise and vibration information — emission values where applicable
- Information on dismantling, disabling, and scrapping — safe disposal guidance
Declaration of Conformity
- Manufacturer’s name and address — registered business address
- Person authorised to compile the technical file — name and address
- Description and identification of the machinery — including generic denomination, function, model, type, serial number, and commercial name
- Statement that the machinery fulfils the relevant provisions of the applicable legislation
- Harmonised standards applied — references, including date of the standard
- Other technical standards and specifications — where harmonised standards are not applied or only partially applied
- Date and place of the declaration
- Identity and signature of the person empowered to draw up the declaration
Translation Readiness
Source Documentation Quality
- Source text is final — no pending revisions, no “draft” watermarks, no sections marked “TBC”
- Technical terminology is consistent — the same component or function is referred to the same way throughout all documents
- Part numbers and model designations are correct and match across all documents
- Diagrams, illustrations, and callouts are complete and correspond to the text
- Units of measurement are correct and appropriate for the target markets (metric for EU)
- Reference standards are correctly cited with proper designations (e.g., EN ISO 12100, not just “ISO 12100”)
Translation-Specific Preparation
- Target languages identified — which EU member states will this machinery be sold in? List the official language(s) required for each market
- Previous translations available — if earlier versions of documentation have been translated, provide these for translation memory leverage
- Glossary or terminology list — any preferred translations for proprietary terms, product names, or technical terminology
- File formats confirmed — what format does the translation agency need? Source files (InDesign, FrameMaker, Word) are preferable to locked PDFs
- Images with embedded text identified — any diagrams, screenshots, or illustrations containing text that also needs translating
- DTP requirements specified — will the translation agency handle desktop publishing, or will you manage layout in-house?
2027 Machinery Regulation: Additional Checks
These additional items apply from 20 January 2027 under Regulation (EU) 2023/1230.
- Digital documentation format decided — will instructions be provided digitally, on paper, or both? (Digital is now permitted, but paper must be available on request free of charge)
- QR code or URL for Declaration of Conformity — if providing digitally, confirm the access method
- Cybersecurity documentation — for machinery with digital elements, document cybersecurity measures, update procedures, and end-of-support timelines
- Updated risk assessment — reflecting the new essential health and safety requirements in the Regulation
- High-risk machinery classification checked — confirm whether your machinery falls under Annex I categories requiring third-party conformity assessment
- Consumer machinery paper requirement — if the machinery is intended for consumer use, safety information must still be provided on paper regardless of digital format adoption
- “Original instructions” labelling removed — the distinction between original and translated instructions no longer applies under the new Regulation; remove this labelling from documentation templates
Pro Tip
Start your translation timeline early. For complex machinery documentation in multiple languages, finalising translations can take 4–8 weeks depending on volume and language count. Working backwards from your planned EU market entry date — or from the 20 January 2027 deadline for Regulation compliance — your source documentation needs to be signed off well in advance. The translation deadline is always earlier than you think.
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