Comparison
Technical File vs User Manual
The Short Answer
The Manual Is One Item in the File
The technical file is the manufacturer's evidence that a machine meets the law. It is kept for authorities and never ships with the product. The user manual is the instructions supplied with the machine so that people can use it safely. Under Regulation (EU) 2023/1230, Annex IV, Part A, a copy of those instructions is one of the elements the technical documentation includes.
So the manual is written for the user and filed for the authority. The same text serves both, which is why it has to be right. The file's other contents, such as the risk assessment, drawings and test reports, are not user-facing and are not manual content.
Side by Side
Five Differences That Matter
| Dimension | Technical file | User manual |
|---|---|---|
| Job | Shows how the manufacturer ensured the machine meets the essential health and safety requirements of Annex III. | Gives the user what they need to use, install, maintain and decommission the machine safely. |
| Reader | National market surveillance authorities on request, and notified bodies during conformity assessment. | Operators, maintainers and installers of the machine. |
| Typical contents | Machine description, risk assessment, drawings and schemes, standards applied, test and calculation reports, production controls, declarations, and a copy of the instructions. | The instructions for use and the information required by section 1.7.4 of Annex III. |
| Where it goes | Kept by the manufacturer. It does not ship with the machine. | Supplied with the machine, on paper or digitally under the conditions of Article 10(7). |
| How long it must be kept | At the disposal of the authorities for at least 10 years after the machine is placed on the market or put into service (Article 10(3)). | Digital instructions must stay accessible online for the machine's expected lifetime and at least 10 years (Article 10(7)). |
The Regulation calls the file "technical documentation". "Technical file" is the common shorthand, and this page uses both.
Inside Annex IV
What the Technical Documentation Includes
Annex IV, Part A says the documentation must specify the means the manufacturer used to ensure the machine meets the applicable essential health and safety requirements of Annex III, and must include at least the elements below. This is a summary, not the list; read the Annex for the full wording, including items on sensor-fed and autonomous machinery and on safety software.
- A complete description of the machinery and its intended use.
- The risk assessment documentation, including the applicable essential requirements and the protective measures chosen, with residual risks where appropriate.
- Design and manufacturing drawings and schemes, and the descriptions needed to understand them.
- The harmonised standards or other technical specifications applied.
- Reports and results of calculations, tests and inspections.
- A description of the production controls that keep series output in line with the design.
- A copy of the instructions for use and the information in section 1.7.4 of Annex III.
- Where relevant, declarations of conformity or incorporation, and for partly completed machinery the assembly instructions.
Article 10(2) makes the manufacturer draw this up before placing the machine on the market and carry out the conformity assessment procedure; the EU declaration of conformity and CE marking follow. Partly completed machinery has its own list in Annex IV, Part B.
Why It Matters
Two Documents That Must Agree
Because a copy of the instructions sits in the file, any mismatch shows up when an authority reads it. The risk assessment names residual risks; the instructions must carry the matching warnings. A revised manual needs a revised copy in the file, and a changed design needs both updated. For the manual's own requirements, including digital delivery, see the Machinery Regulation and digital instructions. For the standards that shape the handbook, see ISO 20607 vs IEC/IEEE 82079-1.
The same split exists elsewhere. The EU AI Act separates the deployer's instructions from the provider's technical documentation (see AI Act instructions for use). Defense work has its own analog, the technical data package, a contract deliverable rather than a conformity record.
This page is general information, not legal advice. Read the text of the Regulation, or ask counsel or your notified body, about what your machine needs.
FAQ
Questions We Hear
Is the user manual part of the technical file?
Yes, for machinery. Annex IV, Part A of Regulation (EU) 2023/1230 lists, among the elements the technical documentation must include, a copy of the instructions for use and the information set out in section 1.7.4 of Annex III. The file holds much more: the risk assessment, drawings, test reports and more.
Does the technical file go to the customer?
No. The manufacturer keeps it and makes it available to market surveillance authorities, and to notified bodies during conformity assessment. The user gets the instructions for use. The Regulation does ask for source code or programming logic of safety-related software to go to authorities on a reasoned request, which is a further reason the file is not a customer document.
How long must the technical file be kept?
Article 10(3) of Regulation (EU) 2023/1230 requires the manufacturer to keep the technical documentation and the EU declaration of conformity at the disposal of the market surveillance authorities for at least 10 years after the machine is placed on the market or put into service. Read the Directive 2006/42/EC text separately if your machine is placed on the market before the Regulation applies.
Is a "technical file" the same as "technical documentation"?
In everyday use, yes. The Regulation's own term is technical documentation, set out in Annex IV. "Technical file" is the shorthand most teams and templates use for it.
What happens when the manual changes?
The copy in the file has to match the instructions you supply. A revised manual means a revised copy in the file, and the revision is a prompt to check the risk assessment too. Version control that links the two is the practical answer; the Regulation does not prescribe a method.
Can this page tell me what my file must contain?
No. It describes the structure of Annex IV for machinery. What your machine needs depends on its type, the conformity assessment procedure, and the text of the Regulation. Read the Regulation, or ask counsel or your notified body.
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