The CE technical file is often discussed as if it were a single document. In practice, it is better understood as the evidence package behind the conformity assessment of a machine.
It connects the machine’s design, identified risks, protective measures, drawings, instructions, checks and other supporting information into a traceable whole. That is also why companies often discover that the technical file is not something that can simply be “added at the end” once the machine is already finished.
The technical file is evidence, not paperwork for its own sake
The purpose of the technical documentation is to make it possible to assess whether the machine meets the applicable requirements. It should therefore reflect the actual machine, its intended use and the safety measures that were really implemented.
For machinery, the documentation may involve information about the machine itself, risk assessment, design and manufacturing information, relevant standards or technical specifications, verification results, instructions and other supporting records.
The important point is not the number of documents. The important point is whether the documents tell one consistent story about how conformity was achieved.
Where companies usually get stuck
Problems usually appear when the machine and the documentation have developed separately.
A drawing may no longer match the final build. A protective device may have been changed during commissioning. A component may have been replaced. The operating instructions may describe an earlier version of the machine. A risk may have been recognised in practice but never reflected in the risk assessment.
Each issue may look small on its own. Together, however, they can make it difficult to demonstrate that the documentation actually represents the machine being placed on the market or put into service.
A technical file is not the same as a template
Templates can help organise information, but they do not determine which requirements apply to a particular machine or which evidence is sufficient.
Two machines that look similar may still differ in control systems, intended use, operating environment, hazards, safety functions or applicable legislation. This is why a generic “CE technical file template” can be a useful starting point but not a substitute for evaluating the actual machine.
The more customised the machinery is, the more important it becomes to connect the documentation to the real design decisions and verification work behind the project.
The difficult part is often consistency
Companies rarely have absolutely no documentation. More often, information exists in several places: CAD files, electrical drawings, component datasheets, test notes, emails, commissioning records, manuals and internal folders.
The challenge is determining what belongs in the conformity assessment file, what is still missing and whether the information is consistent across the project.
This becomes especially important when several people or subcontractors have worked on the machine. One party may have designed the mechanical structure, another the electrical system and another the control software. The manufacturer still needs a coherent documentation package for the final product.
Why leaving the technical file until the end creates extra work
When documentation is considered during design and construction, identified risks, protective measures and verification activities can be documented as the project develops.
When the process starts only after the machine is complete, the company may need to reconstruct decisions from old drawings, emails, component information and conversations with the people who built the machine.
That does not mean an existing machine cannot be documented. It means the review may reveal gaps that are much easier to resolve when they are identified earlier.
What changes in 2027?
Machinery placed on the EU market before 20 January 2027 remains subject to the current Machinery Directive 2006/42/EC. Regulation (EU) 2023/1230 on machinery becomes mandatory from 20 January 2027.
The new Regulation continues to require manufacturers to prepare technical documentation and carry out the applicable conformity assessment. For companies developing machinery now, it is therefore sensible to understand which legal framework applies to the date when the machine will actually be placed on the market or put into service.
Do you need to prepare everything yourself?
No. A manufacturer can prepare the documentation internally, use external support, or combine both approaches. External support does not transfer the manufacturer’s responsibility for the conformity of the product, but it can reduce the time spent identifying gaps, structuring the file and bringing existing information together.
For many companies, the practical question is not whether they are allowed to prepare the file themselves. It is whether they have the time and experience to do it efficiently while the machine project itself is already demanding attention.
Not sure whether your technical file is complete?
You do not need to know exactly what is missing before asking for help.
CE Point can review the machine and the documentation already available, identify the main gaps and define what still needs to be prepared or organised.
Official references: European Commission guidance on machinery and CE marking; Regulation (EU) 2023/1230 on machinery.