From directive to regulation
A directive is transposed into each country’s law; a regulation applies directly and identically in every member state. For manufacturers that means fewer national differences and a single reference for instruction content, found in Annex III, section 1.7.4.
Instructions in digital format
The Regulation allows instructions to be supplied digitally. In exchange, the manufacturer must indicate on the machine or its packaging how to access them, keep them available for the machine’s expected lifetime and at least ten years, and provide them on paper free of charge within one month if the user asks at the time of purchase. Where machinery is also intended for non-professional users, the essential safety information must be supplied on paper.
Language
Instructions must be written in a language easily understood by users, as determined by the member state where the machine is made available. In practice, selling in Germany requires a German version and selling in Spain a Spanish one.
Minimum content
Annex III lists what the manual must include. Among other items:
- Manufacturer’s name and address and the machine designation
- The EU declaration of conformity, or a document setting out its content
- A general description plus the drawings and diagrams needed for use and maintenance
- Intended use and reasonably foreseeable misuse
- Assembly, installation, connection and commissioning instructions
- Residual risks and protective measures the user must take
- Maintenance, adjustment and spare-parts instructions
- Noise emission and other data required by machine type
How to prepare it
The starting point is the risk assessment (ISO 12100): the manual must reflect the residual risks the design does not remove. For document structure, IEC/IEEE 82079-1 (instructions for use) and ISO 20607 (instruction handbook for machinery) are useful references.
The manual is part of the technical file, but the conformity assessment and EU declaration are signed by the manufacturer, and for Annex I machinery notified bodies are involved.
Exporting machinery to Europe? We prepare the manual with the Regulation’s structure.
Get a quote on WhatsAppFrequently asked questions
When does Regulation (EU) 2023/1230 become mandatory?
It applies from 20 January 2027. Until then, Directive 2006/42/EC remains in force.
Can I supply the manual as a PDF only?
Yes, digital format is allowed, but you must provide paper free of charge if the user asks at purchase, and essential safety information must be on paper when the machine is also intended for non-professional users.
References: Regulation (EU) 2023/1230, Article 10 and Annex III section 1.7.4; ISO 12100; IEC/IEEE 82079-1; ISO 20607. This article is for guidance only and does not replace a conformity assessment.