CE Marking User Manual Requirements: Checklist, Example and Template

A CE marking user manual is the document that must accompany a product when it enters the European market and

that tells the user how to install, operate, maintain and safely dispose of it.

Without it, the product cannot be legally placed on the EU market, regardless of how complete the rest of the technical documentation is.

The user manual is one of the mandatory documents within the technical file.

Technical manual or instructions for use: are they the same thing?

In the context of CE marking, yes. “User manual”, “instructions for use”, “technical manual” and “operator manual” all refer to the same document: the one that accompanies the product and is intended for the user. The Machinery Regulation 2023/1230 uses the term “instructions for use” as the official designation, but no directive or regulation prohibits calling it by another name, as long as the content meets the applicable requirements. What matters is not the title on the cover but what the document contains.

When most people hear “instructions”, they picture something like an IKEA assembly sheet: a few diagrams, numbered steps, and a list of parts. EU regulations require considerably more than that. Instructions for use under CE marking cover the full lifecycle of the product, from transport and installation through operation, maintenance and end-of-life disposal, along with safety warnings, residual risk information and personal protective equipment requirements.

What the Machinery Regulation requires: the instructions checklist

The core requirements for instructions for use under the new Machinery Regulation 2023/1230 are substantially identical to those of the Machinery Directive 2006/42/EC. What has been added reflects the evolution of machinery: new obligations on cybersecurity, artificial intelligence and autonomous behaviour must be addressed in the instructions when those features are present in the product.

Section 1.7.4.2 of Annex III of Regulation 2023/1230 sets out the minimum content of the instructions for use (in the Machinery Directive, it’s section 1.7.4.2 of Annex I).

In practice, manufacturers typically group that content into five or six sections: safety warnings and intended use at the front, followed by installation and commissioning, operation, maintenance, and disposal.

The areas below are the core of that list, the legal baseline; how they are structured in the document is a matter of usability and editorial judgment.

1. The manufacturer’s name, full address and country of establishment
2. The designation of the machinery: name, model, series or type reference, serial number
3. The content of the EU Declaration of Conformity, or the declaration itself
4. The intended use of the machinery, including reasonably foreseeable misuse
5. A description of the workstations intended for operators
6. Instructions for transport, handling and storage, including the mass of the machine and its heaviest components
7. Instructions for installation and assembly
8. Instructions for commissioning and initial setup
9. Instructions for normal operation
10. Instructions for maintenance, inspection, and repair, including the qualifications required for maintenance personnel
11. Instructions for decommissioning and disposal
12. Warnings about residual risks that cannot be eliminated by design
13. Instructions on the personal protective equipment required
14. Noise emission values
15. Specifications for the tools that can be fitted to the machinery, where applicable

What other directives require

The obligation to provide instructions for use applies across virtually all CE marking directives and regulations. The Low Voltage Directive, the Radio Equipment Directive and the PPE Regulation all include their own minimum content requirements for instructions. The common thread across all of them is the description of intended use, safety warnings, and maintenance guidance. The specifics vary by directive and by product category, so a product covered by multiple directives needs instructions that satisfy all of them simultaneously.

CE Marking User Manual Example and Template

Here’s what the table of contents of a complete user manual looks like. It’s for the same fictional IoT device we use in our EU Declaration of Conformity example and our CE technical file example, so you can see how the three documents fit together.

The device falls under the Radio Equipment Directive, which is why the manual includes the frequency band, the maximum transmitted power and a simplified EU Declaration of Conformity. A machine needs a longer manual, built around the checklist above.

The standard to follow: EN ISO 20607 and IEC 82079-1

Two standards define best practice for writing compliant instructions for use.

EN ISO 20607 is the specific standard for machinery instructions. It sets out the structure, minimum content, level of detail, language requirements, safety warnings and illustration guidelines for manuals for machinery. It is a harmonised standard under the Machinery Directive 2006/42/EC.

IEC 82079-1 is the horizontal standard for instructions for use across all product categories with CE marking. It covers general principles of drafting, structure, format and verification, and applies regardless of which directive governs the product.

Neither standard is mandatory in the strict legal sense. Following a harmonised standard such as EN ISO 20607 gives a presumption of conformity with the requirements it covers. IEC 82079-1 is not harmonised, so it doesn’t give that presumption, but it’s the recognised reference for good practice. A manual that demonstrably follows EN ISO 20607 or IEC 82079-1 is significantly harder to challenge in a market surveillance audit than one that meets the minimum legal content without reference to any recognised methodology.

Languages: do you need to translate into all EU languages?

Each EU member state defines the official languages required for instructions on products sold in its market. The practical rule is straightforward: if you sell in France, you need French. If you sell in Germany, you need German. A manufacturer selling in several EU countries typically needs between three and ten language versions, depending on which countries the product reaches.

For the UK market, UKCA marking requires instructions in English. A manual published only in English does not satisfy CE marking requirements in non-English-speaking markets, and a manual published only in other languages does not satisfy UKCA requirements.

Managing translations and keeping them current when the product changes is one of the most common sources of compliance gaps identified during market surveillance checks.

Can a CE Marking User Manual Be Digital?

The direction across EU product legislation is consistent: instructions for use are increasingly permitted, and in some cases encouraged, in digital format. The new Machinery Regulation 2023/1230 is the most explicit example to date: instructions may be delivered as a downloadable PDF, an app, or a QR code on the product linking to an online version. A paper copy must be provided free of charge if the user asks for it at the time of purchase, and machinery that non-professional users may use must come with the essential safety information on paper.

A similar move toward digital product information appears in the General Product Safety Regulation, the Battery Regulation, and the Digital Product Passport framework. Paper instructions are becoming an option available on request rather than the default.

The conditions that apply consistently across these frameworks: the digital version must be accessible without registration, without cost, and must remain available for the full service life of the product. A URL or QR code that stops working five years after sale constitutes a compliance failure. The long-term management of digital access points is a responsibility many manufacturers underestimate when they first move to digital documentation.

Is my existing manual acceptable for CE marking?

The most common question from non-European manufacturers is this: the manual meets the requirements of my home market, whether that is ANSI, UL or an Australian standard. Does it work for CE marking?

In most cases, the answer is no, or not without adaptation. The content requirements, structure and warning conventions of American and Australian standards differ from European requirements in specific areas. Warning levels defined under ANSI Z535 do not map directly onto the European approach. The order and completeness of sections differ. Instructions for decommissioning and disposal, mandatory under the Machinery Regulation, are frequently absent from manuals written primarily for North American markets.

Beyond the structural differences, any product that has been modified since the last manual revision requires updated instructions before it can be placed on the EU market under the new regulation, particularly if the modification affects safety-relevant features.

The most practical starting point is a gap analysis of the existing manual against the instructions requirements and the applicable harmonised standards. Tell us about your project.

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