Are instructions for use truly mandatory?

Yes, without exception. The Machinery Directive 2006/42/EC requires them for every machine placed on the European market. Regulation 2023/1230 maintains this obligation from 20 January 2027. The absence of instructions for use at the time of placing on the market constitutes a non-compliance that may result in a ban on sales.

In which language must instructions for use be written?

Instructions for use must be written in the official language or languages of the country or countries of destination of the machine. If the machine is sold in several European countries, a version in each relevant language is mandatory.

What is the difference between instructions for use and an operating manual?

Instructions for use is a regulatory document focused on safety, required by the Machinery Directive. An operating manual may adopt a more educational or commercial register, depending on the product and its audience. Both frequently coexist for the same piece of equipment.

Can instructions for use be written by an external service provider?

Yes. The manufacturer remains legally responsible for the instructions for use, but their drafting can be entrusted to a specialist. LCSI handles full creation or revision of existing documents, working alongside your technical teams.

Must instructions for use be updated when the machine is modified?

Yes. Any significant modification to the machine must be reflected in the instructions for use. If the modification is considered substantial within the meaning of Regulation 2023/1230, a new EC declaration of conformity is also required.

Mandatory instructions for use: regulatory content

Every machine placed on the European market must be accompanied by instructions for use. This is not optional: it is a legal obligation set out in the Machinery Directive 2006/42/EC, maintained and reinforced by Regulation (EU) 2023/1230 from 20 January 2027. In the event of an inspection, accident or dispute, the instructions for use is the first document that the authorities examine.

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What are mandatory instructions for use?

The instructions for use is the regulatory document provided to the user with each machine or industrial equipment placed on the market. It is written by the manufacturer (or on their behalf) and must be available in the language of the country where the machine is sold.

Its role is twofold: to guarantee the safety of operators in the field, and to demonstrate to the supervisory authorities that the manufacturer has met their regulatory obligations.

Instructions for use are not a simple user guide. They are a legal document that engages the civil and criminal liability of the manufacturer.

Mandatory regulatory content of instructions for use

Annex I, section 1.7.4 of the Machinery Directive 2006/42/EC sets out the minimum content that any compliant instructions for use must cover. This content is taken up and clarified by Regulation 2023/1230 for machines incorporating digital components.

Compliant instructions for use must include:

The description and identification of the machine (designation, model, serial number, manufacturer's contact details)

The conditions of intended use and reasonably foreseeable misuse

Specific safety instructions and warnings for the machine

Procedures for commissioning, adjustment and shutdown

Maintenance operations authorised to the user and their intervals

Information on noise and vibration emissions and hazardous substances

Operating limits and prohibited uses

End-of-life disposal instructions

For connected or autonomous machines, Regulation 2023/1230 adds additional requirements: management of software updates, cybersecurity measures the user must follow, and procedures in the event of a digital function failure.

Instructions for use and manufacturer liability

Incomplete, absent or incorrectly translated instructions for use directly engage the civil and criminal liability of the manufacturer in the event of an accident. Market surveillance authorities (DGCCRF, DREETS) may request them at any time.

Beyond compliance, poorly written instructions for use also represent an operational risk: incorrect use of the machine, production downtime, avoidable accidents. Writing quality matters as much as regulatory content.

Instructions for use and the technical construction file

The instructions for use is one of the constituent documents of the technical construction file (TCF), which the manufacturer must retain for at least 10 years after the manufacture of the last unit of the machine. It is also included with the EC declaration of conformity provided to the buyer.

These three documents, instructions for use, TCF and EC declaration of conformity, form the backbone of a machine's regulatory compliance. The absence of any one of them is sufficient to invalidate CE marking.

To go further on the full composition of the technical file: Machinery CE technical file: what must it contain exactly?

Transition to Regulation 2023/1230: what changes for instructions for use

The Machinery Directive 2006/42/EC will be replaced by Regulation (EU) 2023/1230 on 20 January 2027. For instructions for use, the changes primarily concern connected, autonomous or software-integrated machines.

These machines will require enhanced instructions covering:

Risks associated with embedded software and its updates

Cybersecurity measures the user must follow

Operating conditions in autonomous or semi-autonomous mode

Procedures to follow in the event of a digital function failure

For purely mechanical machines without digital components, the substantive requirements remain close to those of the Directive. However, a formal verification is recommended before any machine is placed on the market after January 2027.

How LCSI writes your instructions for use

LCSI writes instructions for use compliant with the Machinery Directive 2006/42/EC and Regulation 2023/1230, for special-purpose machine manufacturers, industrial line integrators and equipment manufacturers.

We provide full creation or revision of existing instructions for use:

Compliance review of instructions for use

Restructuring of instructions for use

Clarification of instructions for use

Translation of instructions for use

Each document is designed to be usable in the field. The writing is based on a thorough understanding of how the machine actually works and who uses it. Safety instructions are clearly prioritised, procedures are unambiguously worded, and technical diagrams and illustrations are included where the machine requires them.

We work remotely or on site, on one-off projects or as part of an ongoing documentary management arrangement.

Are your instructions for use compliant?

Mandatory content, language of drafting, transition to Regulation 2023/1230: LCSI writes and updates your instructions for use for any industrial machine.

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Frequently asked questions about mandatory instructions for use

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