Glossary · Machinery law and conformity
Technical file
Also known as: technical documentation file, technical dossier, technical construction file
In EU machinery law, the technical file is the body of technical documentation used to demonstrate conformity with applicable machinery requirements. It is compiled by the manufacturer, kept available for market surveillance authorities and is not normally supplied to users.
- Compliance
- Technical documentation
- EU
In one sentence
The technical file is the manufacturer’s body of documentation that demonstrates a machine’s conformity to authorities, not to users.
Example
The technical file of a robot cell contains the general description, drawings and circuit diagrams, the risk assessment, the list of standards applied, test and validation reports, a copy of the instructions and the declaration of conformity.
Explained in context
Context cards connect this term with others to answer one question. Also in British English and German.
- Instructions for use: one manual or a set of information products?Do "instructions for use" mean one user manual or a collection of documents?UKDeutsch
- Internal and external technical documentation: what "external" really meansDoes "external documentation" mean documentation that is published?UKDeutsch
- Retrofit and substantial modification under the Machinery RegulationWhen does a retrofit make the operator the manufacturer of a machine?UKDeutsch
How it applies
- Content: Description of the machine, drawings and calculations, the risk assessment with the measures taken and residual risks, standards and specifications applied, test reports, the instructions, and the declaration of conformity. Directive 2006/42/EC lists the content in Annex VII; the Machinery Regulation calls it technical documentation.
- Retention: Keep it for at least ten years after the machine, or the last unit of a series, is placed on the market, and make it available on reasoned request.
- Evidence: The file is only as good as its links. Each claim should point to evidence that is valid for the configuration shipped; see evidence control.
- Integrated systems: For assembled lines, the person assembling the machinery compiles a file for the assembly, including partly completed machinery and its declarations of incorporation.
Technical file vs. technical documentation (AI Act)
Both serve authorities rather than users. The machinery file demonstrates health and safety conformity; technical documentation (AI Act) follows Annex IV of the AI Act and covers data, model development, human oversight and performance metrics. For AI embedded in machinery, the AI documentation becomes part of the machine's conformity assessment evidence.