A technical file is the set of documents that proves a machine meets EU safety law. The manufacturer compiles it before placing the machine on the market and must be able to give it to a national authority on a reasoned request.
It is the evidence behind the declaration of conformity. Without it, the CE marking has nothing to stand on.
What goes in it
- A general description of the machine and its intended use, including reasonably foreseeable misuse.
- An overall drawing, plus the control circuit diagrams and the descriptions needed to understand how the machine works.
- Detailed drawings, calculations and test results needed to check the machine against the essential requirements.
- The risk assessment, showing the hazards found and the measures taken to remove or reduce each one.
- The list of essential health and safety requirements that apply, and the standards and specifications used.
- Technical reports, such as noise measurements, electrical tests and safety function validation.
- A copy of the instructions and of the declaration of conformity.
- For series production, the internal measures that keep each unit consistent with the design.
Who keeps it, and for how long
The manufacturer keeps the technical file. It must be available for at least 10 years, and the exact starting point depends on whether the Machinery Directive or the new EU Machinery Regulation applies.
A manufacturer in India does not have to hand the full file to you. It contains its design know-how, and many makers will refuse. What matters is that the file exists and can reach an EU authority when asked. Agree in your contract that the manufacturer will supply it, or the relevant parts, to the authority within a set time.
If you sell the machine under your own brand, you become the manufacturer in law. In that case you need the file, or full access to it, because the duty is now yours.
How to check a supplier's file
Ask for the file's index and the risk assessment. A real risk assessment names specific hazards on this machine, such as a crushing point at a press tool or a hot surface on a dryer. A generic one that could apply to any machine is a red flag.
Then check a few links. Pick a hazard, find the measure in the risk assessment, and look for it on the actual machine during inspection. Check that the standards listed are current and relevant.
A notified body or CE consultant can review the file for you before you commit. For high-risk machinery, a notified body may need to examine it formally.
Next step
We check that what the documents describe is what the factory built. To review a supplier's CE documents before you order, book a free sourcing review.