In eight steps: classify the product, determine the applicable legislation and standards, carry out the risk assessment, implement protective measures, compile the technical documentation, write the instructions for use, go through the conformity assessment procedure, and finally issue the declaration of conformity and affix the CE marking.
| Product type | Declaration | Instructions | CE marking |
|---|---|---|---|
| Machinery | EU declaration of conformity | Instructions for use | Yes |
| Partly completed machinery | Declaration of incorporation | Assembly instructions | No |
| Assembly of machinery | EU declaration of conformity for the whole installation | Instructions for use of the whole installation | Yes, for the whole installation |
| Safety component | EU declaration of conformity | Instructions with installation and safety data | Yes |
Partly completed machinery receives no CE marking under the Machinery Regulation. It may only be put into service once it has become part of a conform final machine.
The honest answer: it depends almost entirely on when you start.
If the risk assessment runs alongside the design work and the documentation is kept up to date, the formal conclusion is a matter of days, because the work is already done.
If everything is pushed to the end of the project, a typical special purpose machine quickly takes several weeks: catching up on the risk assessment, producing evidence for the safety functions, writing the instructions for use, sorting the documents. And design faults that step 1 of the three-step method could have avoided can then only be compensated expensively with safeguards.
Where a notified body comes into play, its schedule dominates the timeline. Plan generously here; towards the deadline of 20 January 2027 demand is likely to rise sharply.
Editions of standards and their harmonised status change continuously. Check standard numbers and editions against the current list in the Official Journal of the EU before applying them. This article is a technical classification and does not replace legal advice.
Only the manufacturer or its authorised representative. By affixing it they declare that the machine meets all applicable legislation and that the prescribed conformity assessment procedure has been carried out.
For every machine type. For series machines the assessment covers the model range, provided the individual units are technically identical. Variants and customer-specific adaptations have to be assessed in addition.
There is no flat figure; the effort scales with complexity, the situation regarding standards and internal maturity. The biggest cost lever is the starting point: begun early, the documentation is a by-product of the design work; begun late, it is a project of its own.
No. There is no prior approval. The market surveillance authority can however request the technical documentation afterwards upon reasoned request, which is why it has to remain available for ten years.
Has been guiding CE projects in machinery, plant and special purpose engineering for years. That work led to Kaidoc.app, a software for standards-based CE documentation. Through Knutec.de the same work is available as a personal service.
Write me a few lines about your project. You get a first assessment back, free of charge and without obligation.
This article was produced with AI assistance and reviewed for technical accuracy before publication. Editorial responsibility within the meaning of Art. 50(4) of the AI Act (EU) 2024/1689 lies with Heinrich Knutas.
No credit card required. A complete project to try out.