Which technical documentation does a machine need?
The technical documentation covers everything that demonstrates the conformity of the machine: overall drawing and circuit diagrams, risk assessment, calculations and test records, the list of applied standards and legislation, the instructions for use and the declaration of conformity. It stays with the manufacturer and has to be submitted to the market surveillance authority upon reasoned request, for at least ten years.
What belongs in the technical documentation?
What does the customer get, what stays with the manufacturer?
| Document | Supplied with the machine | In the technical file |
|---|---|---|
| Instructions for use | Yes | Yes |
| EU declaration of conformity | Yes | Yes |
| Risk assessment | No | Yes |
| Design drawings, calculations | No | Yes |
| Test records, performance level evidence | No | Yes |
| Circuit diagrams | As far as needed for operation and maintenance | Yes, in full |
| Spare parts and maintenance information | Yes | Yes |
The technical file is not a customer document. It demonstrates to market surveillance that conformity was derived methodically.
Who has to keep the documents available, and for how long?
The manufacturer has to keep them. If the manufacturer is based outside the EU, an authorised representative established in the Union has to be appointed who can submit the documents on request. That person is named in the declaration of conformity.
The period is at least ten years from placing on the market. For series products it starts with the last unit delivered.
The documents do not have to sit physically in one place. But they have to be capable of being submitted in full within a reasonable period upon reasoned request by the market surveillance authority. In practice this fails less often because individual documents are missing than because nobody knows where the version belonging to the machine delivered is kept.
So: tie the revision status of the documents to the serial number. Anyone who after eight years can no longer reconstruct which software version and which circuit diagram revision belonged to machine 0247 effectively does not have the documentation.
Sources and standards
- Machinery Regulation (EU) 2023/1230, technical documentation, retention periods
- EN ISO 12100: risk assessment and risk reduction
- EN 60204-1: electrical equipment of machines, tests
- EN ISO 20607: instruction handbook, general drafting principles
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.
Frequently asked questions
Do I have to give the customer the risk assessment?
No. It is part of the technical documentation and stays with the manufacturer. The customer receives the residual risks derived from it through the instructions for use. Handing it over can of course be agreed contractually; it is not obligatory.
In which language does the technical documentation have to be?
For the internal file there is no requirement like the one for instructions for use. The authority can however request a translation into a language it understands. Instructions for use and the declaration of conformity are subject to the language requirement of the country of destination.
Is digital storage enough?
Yes. What matters is that the documents are complete, unambiguously assignable to a machine and legible throughout the period. Pay attention to file formats that can still be opened in ten years.
What has to be done for an assembly of machinery?
The manufacturer of the whole installation keeps a technical file of its own for that installation. The documents and declarations of the individual machines become part of that file, which is why you should agree their handover contractually.
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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.
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