Either because a CE documentation audit has shown exactly what is missing — or because you know that existing documentation cannot be saved with patches. The CE compliance package produces the documents: Declaration of Conformity, user manual and technical file, written from scratch in full compliance with EU Machinery Regulation 2023/1230. Assessment is not our job here — production is.
When do you need a CE compliance package?
A CE compliance package is the right choice when one or more of the following applies:
- New machinery for the EU market. The machine is designed and ready for production, but there is no CE documentation yet. You need a Declaration of Conformity, user manual and technical file produced from scratch — before placing on the market.
- Existing documentation cannot be saved. A CE documentation audit has shown that your current documentation has so many critical gaps that patching is more expensive and less reliable than starting from scratch.
- Regulatory change requires a complete rewrite. Your documentation was issued under Machinery Directive 2006/42/EC and does not meet EU Machinery Regulation 2023/1230 — in structure, content or standard references.
- New product line or substantial modification. A substantial modification to the machinery requires a new CE assessment. We produce all documentation for the updated configuration.
- Multilingual delivery requirement. You export to markets requiring documentation in Ukrainian, Russian or English — in addition to Danish — and need all documentation delivered consistently from one place.
Not sure whether your existing documentation can be updated or needs to be rewritten? Start with a CE documentation audit →
What is included
The compliance package covers all three document types required for CE marking of machinery:
| Document | What we produce |
|---|---|
| Declaration of Conformity | Complete rewrite to Regulation (EU) 2023/1230 — correct structure, valid standards list, authorised representative and cybersecurity reference where applicable |
| User manual | Full compliance with IEC/IEEE 82079-1:2019 and ISO 20607:2019 — audience separation, information type structure, controlled language, correct warning system and navigable structure |
| Technical file — documentation support | Structuring of risk assessment, organisation of test results and drawings, cybersecurity documentation for machinery with digital components |
| Multilingual delivery | DA · EN · UK · RU as required — produced by Contenza's own documentation specialists, not machine translation |
Regulatory basis
All documentation is produced against two regulatory frameworks, both of which are mandatory for machinery under CE marking:
| Framework | Application |
|---|---|
| EU Machinery Regulation 2023/1230 | Replaces Machinery Directive 2006/42/EC on 20 January 2027. Defines the requirements for the Declaration of Conformity, the technical file and cybersecurity documentation |
| IEC/IEEE 82079-1:2019 | Replaces IEC 82079-1:2012. The international standard for the structure, language and format of user manuals — harmonised under the Machinery Regulation |
| ISO 20607:2019 | Specific standard for safety manuals for machinery — supplements IEC/IEEE 82079-1:2019 with requirements for warnings, safety distances and foreseeable misuse |
Digital delivery via TekDok Portal
EU Machinery Regulation 2023/1230 permits digital delivery of the user manual under specified conditions. Contenza's TekDok Portal offers structured digital hosting of CE documentation — searchable, version-controlled and accessible in all languages.
Digital delivery is an add-on to the compliance package. Documentation is always delivered in editable source files regardless of delivery format.
Fixed price. No hourly rate. The compliance package is priced on the basis of scope: which document types are included, the complexity of the documentation and the number of languages. No open invoices along the way. Copyright is transferred to you on final payment.
Production process
All documentation is produced according to Contenza's 12-stage standard process, which ensures quality control and IP protection at every step:
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01
Proposal
Scope and price are established on the basis of the audit report or an initial assessment of existing documentation.
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02
Contract
Written agreement with precise scope definition, delivery schedule and terms for IP transfer.
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03
Advance payment and material intake
Advance payment confirms project start. You submit existing documentation, drawings, risk assessments and product description.
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04
Text production
Contenza produces all text in the source language. Watermarking of drafts protects both parties' IP throughout the process.
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05
Text review
You review the text and return comments. Contenza incorporates revisions and confirms agreement on content.
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06
Layout, layout review and final approval
Documents are produced in final format. You approve layout and content. Watermark is removed on approval.
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07
Delivery and invoicing
Completed documents are delivered in the agreed format — PDF, Word, structured XML source files or publication to TekDok Portal. Copyright is transferred on final payment.
What you receive
- Declaration of Conformity rewritten to Regulation (EU) 2023/1230
- User manual in full compliance with IEC/IEEE 82079-1:2019 and ISO 20607:2019
- Documentation support for the technical file
- Multilingual delivery in agreed languages
- Editable source files in agreed format
- Full IP transfer on final payment
- Documentation that meets the January 2027 deadline
Get a quote for a CE compliance package
Tell us briefly about the machine and the situation — which documents need to be produced and in which languages. We will get back to you with scope and price.
Contact us →Not sure whether you need a full rewrite? Start with a CE documentation audit →