REFERENCE / Documentation
Machinery technical file: anatomy of the evidence
Organise the technical record around the actual product, its risk assessment and the evidence supporting applicable requirements.
The Directive remains the current framework before 20 January 2027. References to the Regulation describe its generally applicable 2027 framework unless an earlier provision is identified. This is independent educational information.
Use the correct annex
For complete machinery under the current Directive, technical-file requirements are in Annex VII, Part A. Under the Regulation, technical documentation for machinery and related products is in Annex IV, Part A. Partly completed machinery has a separate documentation section in each framework.
A technical file is more than a folder of purchased-component declarations. It should explain the machine as supplied and the engineering basis for meeting the relevant essential requirements. Organising documents by evidence purpose makes later review easier than collecting unlabelled attachments.
The main evidence groups
Start with a product description and the intended use. Include the drawings and explanations needed to understand the design and operation, alongside risk-assessment documentation. Identify applicable requirements, protective measures and any residual risks.
The Regulation’s documentation annex also addresses standards or other technical specifications used, calculations, examinations and tests, and production measures supporting conformity. Include instructions and relevant incorporation documents where appropriate. The exact contents must follow the applicable annex and the product, not this brief summary alone.
Make retrieval practical
Assign an owner to the index. Use product identifiers, revisions and links to the evidence. Distinguish superseded drawings from those describing the supplied configuration. A useful review asks whether another competent person could find the evidence behind a requirement without relying on one engineer’s memory.
Under Article 10(3) of the Regulation, manufacturers keep technical documentation and the EU declaration of conformity available to market-surveillance authorities for at least ten years after market placement or putting into service. Relevant source code or programming logic may need to be provided following a reasoned request where necessary to check compliance.
Keep the file aligned with change
Changes to the product and production process can affect the conformity evidence. Review the assessment, drawings, test results and instructions together rather than updating only the visible manual.
The checklist in this publication is a working aid. It does not replace the full annex, nor does ticking every item certify the machine. For partly completed machinery, use the appropriate technical documentation and incorporation pathway.
Sources & related reading
- Regulation (EU) 2023/1230, consolidated 27 July 2026: Article 10 and Annex IV, Part A.
- Directive 2006/42/EC, consolidated text: current framework.
- European Commission machinery legislation and guidance.
Continue with eu machinery law: the working framework, machinery regulation: the 2027 transition, machinery scope and product definitions.
Machine-specific interpretation and verification need competent assessment. This publication does not give legal advice or guarantee compliance.