The EU technical file
This is the document that decides whether your CE marking survives contact with an authority.
Everything else is visible: the mark on the plate, the Declaration in the shipping folder, the manual in the crate. The technical file is the only part nobody sees until something goes wrong — and then it is the only part that matters. If you cannot produce it on request, the Directive says plainly that this alone may be sufficient grounds for doubting that your machine complies.
Fact — check it yourself
Not “may raise questions.” Sufficient grounds.
The absence of the file is treated as evidence against the machine.
Directive 2006/42/EC, Annex VII, A.3
What it has to contain
Under the Machinery Directive in force today, a construction file comprising:
- A general description of the machine.
- The overall drawing, drawings of the control circuits, and the descriptions needed to understand how the machine operates.
- Full detailed drawings, with calculation notes, test results and certificates — everything needed to check conformity against the health and safety requirements.
- The risk assessment documentation, demonstrating the procedure actually followed. It must include the list of health and safety requirements that apply to your machine, and a description of the protective measures implemented for each — plus the residual risks where relevant.
- The standards and technical specifications used, indicating which requirements each one covers.
- Any technical report with test results, whether the tests were run by you or by a body you chose.
- A copy of the instructions.
- Declarations of incorporation for any partly completed machinery you integrated, with its assembly instructions.
- Copies of the Declarations of Conformity of products incorporated into your machine.
- A copy of your own Declaration of Conformity.
- For series production: the internal measures that keep later units in conformity.
Two points that save arguments later:
- You do not owe detailed plans of every bought-in sub-assembly — only where knowing them is essential to verify conformity. You are not expected to reverse-engineer your suppliers.
- The file is compiled in an official EU language, with one exception: the instructions follow their own rule, and must be in the language of the country where the machine is placed on the market. A single English file does not discharge the manual obligation for a machine sold in Italy or Germany.
What the 2027 Regulation adds, and why it matters more than it sounds
The Regulation keeps all of the above and restructures it. Two additions are genuinely new, and neither is being widely communicated.
Fact — check it yourself
1. Safety-related software source code, on request.
The technical documentation must include the source code or programming logic of safety-related software, to be provided further to a reasoned request from a national authority, where that is necessary for the authority to check conformity with the health and safety requirements.
Reg. (EU) 2023/1230, Annex IV, Part A, point (m)
Read that again if you write your own safety logic. It does not mean publishing your code, and it does not mean handing it over routinely — the request has to be reasoned and the need has to be demonstrated. But it does mean the code has to be identifiable, versioned and retrievable for at least ten years, tied to the specific machine it shipped with. If your safety logic lives in an engineer’s laptop with a filename ending in _final_v3_REAL, that is a compliance gap, not an IT habit.
Fact — check it yourself
2. Sensor-fed, remotely-driven and autonomous machinery.
Where safety-related operations are controlled by sensor data, the documentation must describe the general characteristics, capabilities and limitations of the system, the data, and the development, testing and validation processes used.
Reg. (EU) 2023/1230, Annex IV, Part A, point (n)
The word doing the work is limitations. You will be documenting what your system cannot reliably do — which is a different exercise from documenting what it can, and it needs to start at design stage, not at file-assembly stage.
If your machine has a vision system, a lidar, a remote operating mode or any learned behaviour in a safety function, these two points are the reason 2027 is a design problem for you and not a paperwork problem.
Where you keep it, and for how long
Fact — check it yourself
It does not have to be in Europe.
The Directive is explicit: the technical file need not be located in EU territory, and need not be permanently available in material form. For a U.S. manufacturer this removes the objection that usually comes up first.
Directive 2006/42/EC, Annex VII, A.2
It does have to be producible. The file must be capable of being assembled and made available within a time commensurate with its complexity — by the person named in the Declaration of Conformity. That named person is the test. If they left the company in 2023, you have a problem that no filing system solves.
Ten years — but from a moving anchor. Under the current Directive: at least ten years from the date of manufacture, or of the last unit for series production. Under the 2027 Regulation: at least ten years after the machine is placed on the market. Same duration, different start date, and for a machine that sits in inventory the difference is real.
Someone in the EU has to be able to produce it on request. That is a separate obligation, and it is the one U.S. manufacturers miss most often.
What a file that fails an audit looks like
We see the same four failure modes, and none of them are exotic:
- The risk assessment was written after the design. It reads as a justification of decisions already made rather than a record of decisions being taken. An experienced inspector spots this in minutes, because the residual risks are always conveniently zero.
- The standards list is aspirational. Standards are cited that were never actually applied, or cited without saying which requirements they cover. That last omission is explicitly required by the Directive, and it is the most common defect we find.
- Incorporated products are undocumented. Bought-in safety components, partly completed machinery, a purchased control panel — each carries its own paperwork, and each one missing is a hole.
- Nobody can find it. Distributed across a shared drive, three engineers and a supplier, with no index and no version control. The file technically exists and cannot be produced, which for legal purposes is the same as not existing.
What we do
We build the file, or we audit the one you have and give you the gap list first. If you already have drawings, an existing risk assessment, UL documentation or test reports, most of that is usable evidence — it needs to be organised, mapped to the requirements it satisfies, and completed where it does not reach.
The deliverable is a file another engineer can pick up and defend, and an index that tells a market surveillance authority exactly where to look.