Machinery Directive, EU Directive

10.10.2025: The site is under construction - ERRORS AND OMISSIONS RESERVED

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Standards – and the Machinery Directive, which becomes the Machinery Regulation

Machinery Directive

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WARNING!
This page is only a general introduction.
It does NOT replace a review of applicable legislation and standards.
The manufacturer always has full responsibility for compliance and CE marking.

Two common standards for instructions for use:

❶ DS/EN IEC/IEEE 82079-1:2020 – to product guides
❷ DS/EN ISO 20607:2019 – when you need to CE mark according to Machinery Directive

20. January 2027: ❌ The Machinery Directive (2006/42/EC) is replaced by  ✅ Machinery Regulation (EU 2023/1230)

10.1 What's new?

DIRECTIVE: you must implement it into national law. REGULATION: applies directly in all EU countries.
The Machinery Regulation largely follows on from the Machinery Directive. However, there are significant new features:

10.1 What's new?

  1. Scope adjusted:
    • “High-risk” machines: Updated list of categories
      Several require a notified body
    • Submachines and assembly: The rules are clarified
  2. Software: can now be a safety component in itself
    Updates may affect CE compliance
  3. AI and autonomous features:
    Machines with self-learning or adaptive behavior are explicitly covered
    Focus on unpredictable behavior and risks
  4. Cybersecurity (security-related):
    Protection against manipulation that could lead to dangerous situations
    Not an IT requirement – ​​but a security requirement
  5. Instructions for use:
    The supplier may deliver exclusively digitally (under certain conditions)
    Paper only on request

Guidelines according to standards – part of the product cycle:

5.4 Standards and process (compact)

5.4 Standards and process for product development

The preparation of an instruction manual is part of the process of developing, designing, producing, marketing and documenting a product - in accordance with EU directives. Here is the overall process:

A. Concept and development
  1. Define the product's function, target group and use.
  2. Identify the EU directives and national regulations that the product is covered by.
  3. Determine the harmonized standards that will form the basis for design and documentation.
B. Construction and design
  1. Construct the product in accordance with the selected standards.
  2. Carry out a risk assessment (e.g. according to EN ISO 12100).
  3. Use the results to determine technical protection measures and user information requirements.
C. Preparation of instructions for use – early in the process
  1. Plan and prepare the User Manual in parallel with product development.
  2. Use DS/EN IEC/IEEE 82079-1:2020 as the basis for structure, content, language and usability.
  3. If the product is a machine: Also use DS/EN ISO 20607:2019 to ensure correct safety information and integration with the CE marking.
D. Testing and validation
  1. Test the product technically.
  2. Verify the Instructions for Use through user testing.
  3. Check the Documentation to ensure that the product can be used safely and correctly.

 Comparison: They both overlap and complement each other:

Punkt ❶
DS/EN IEC/IEEE 82079-1:2020		 ❷
DS/EN ISO 20607:2019
Title Preparation of user manuals – Principles and general requirements Safety of machinery – Instructions for use – General requirements
Area of ​​application All types products and systems (mechanical, electrical, software, etc.) Only machines covered by the Machinery Directive, which on January 20, 2027, will be replaced by the MACHINERY REGULATION
Purpose Determines general principles for good user manual Indicates safety-related requirements for machine operating instructions
Directive relation No direct link to one directive, but relevant for all CE products Supports the requirements of Annex I, point 1.7.4 of the Machinery Directive
Content type Structure, terminology, information level, life cycle and user profile Safety information, warnings, residual risks, maintenance
Audience Anyone who prepares user manuals Producers of machines and machine parts
Standard type Type B (generic) Type B (safety-related)
Supplements Can be combined with ISO/IEC 82079-2 and -3, EN 82079-1 previous edition Complements 82079-1 for the machinery area
Status in the CE context Gives best practice but NOT CONSUMPTION on compliance” Harmonized standard → gives CONSUMPTION about compliance

Buy the two COMPLETE standards from Dansk Standard – here only the ESSENCE :

 ❶

DS/EN IEC/IEEE 82079-1:2020:
Preparation of user manuals (instructions for use) for products – Part 1: Principles and general requirements

Machinery Directive

They are a headline

WARNING!
This description is only a abstract.
The full conformity: Kopen it complete standard, and translate the requirements into practice.

1. Contents​

1.1 Purpose and target group clearly specified?
1.2 Completeness: Does the text cover all necessary functions, processes and prerequisites?
1.3 Precision: Are all data, measurements, tolerances, units of measurement and references correct and consistent?
1.4 Update: Version, revision date and change history indicated?
1.5 Security & Compliance: Safety instructions, warnings, standards (e.g. ISO/EN) correct?

2. Structure and navigation

2.1 Textured: Logical chapters: Use, operation, maintenance...?
2.2 Table of contents: Auto-generated TOC – with H1, H2, H3?
2.3 Cross-references: Are internal links correct and clickable (PDF/HTML)?
2.4 Numbering – paragraphs, figures: Consistent and machine-readable?
2.5 Modular division: The information is divided into reusable “topics” – absolutely central to Single-Source Publishing)?

3. Illustrations and graphic elements

3.1 Relevance: Does each illustration support the text and add value?
3.2 Quality: High resolution, correct color profile, no pixelation?
3.3 Clarity: Labels easy to read, scalable (SVG/Vector, if possible)?
3.4 Consistency: Uniform style (line thickness, colors, fonts)?
3.5 Location: Figures close to associated text and with captions?
3.6 Accessibility: All text (for web/PDF) and contrast requirements met?

4. Language and terminology

4.1 Clarity: Short, precise sentences, active language?
4.2 Terminology: Uniform use of technical terms, with a glossary/glossary?
4.3 Language standard: Correct grammar and punctuation, style guide (e.g. British English)?
4.4 Translation-friendly: No idioms, long sentences, variables/constants correct?
4.5 Tone: Neutral, instructive and without marketing jargon?

5. Layout and publishing

5.1 Template: Does the document follow the organization's official layout (logo, colors, typography)?
5.2 Responsiveness/printing: Works on screen, tablet and print?
5.3 Metadata/SEO: Title, author, keywords, descriptions correctly filled in (relevant for web)?
5.4 Version control: File name, version number and possibly Git/PLM link registered?

6. Quality assurance

6.1 Peer review: Has another professional performed a technical and linguistic review?
6.2 User testing: Have the instructions been tested by a representative user group?
6.3 Error handling: Is there a plan for maintenance and updates after release.

You can read more here.

You buy the COMPLETE standard 

here at Danish Standard

Machinery Directive

They are a headline

WARNING!
This description is only a abstract.
The full conformity: Kopen it complete standard, and translate the requirements into practice.

 ❷


DS/EN ISO 20607:2019:
Safety of machinery – Instructions for use – General requirements

Machinery Directive

They are a headline

WARNING!
This description is only a abstract.
The full conformity: Kopen it complete standard, and translate the requirements into practice.

They are a headline

This standard is a RECOMMENDATION if you need to CE mark according to the Machinery Directive – from January 20, 2027 according to the Machinery DIRECTIVE


CE marking according to the Machinery Directive - the 5 basic steps

1. Scope

1.1 Purpose: Requirements for safety-related parts of the user manual
1.2 Extension of ISO 12100:2010, clause 6.4.5
1.3 Covers the entire machine life cycle

2. Normative references
2.1 ISO 12100:2010 – Safety of machinery

3. Terms and definitions
3.1 “Instruction handbook” – safety-related user guide
3.2 “Integrator” – responsible for overall security strategy
3.3 “Risk reduction measure” – measure to reduce risks
3.4 “Vulnerable user” – user with special risk factors

4. General information
4.1 Purpose: ensure safe use including reasonably foreseeable misuse
4.2 Target group: operator, service, cleaning, etc.
4.3 Language and expression: consistency, active form, clear units
4.4 Presentation: one or more documents, divided by life cycle
4.5 Information from component/system suppliers
4.6 Legibility: Text and symbols must be clear
4.7 Warnings and danger symbols: clear signal words and consequences
4.8 Structuring: Quick access to hazard information
4.9 Description of safety guards and signaling systems
4.10 IT security aspects, where relevant

5. Content and structure
5.1 Table of contents
5.2 Operating instructions: start, stop, emergencies, error messages
5.3 Maintenance and inspection
5.4 Drawings and spare parts lists
5.5 Warnings and precautions

6. Warnings
6.1 Signal words: DANGER, WARNING, CAUTION
6.2 Wording: clear text, no ambiguity

7. Publication
7.1 Delivery as agreed (paper, digital, etc.)
7.2 Multilingual versions as needed

 

You can read more here.

You buy the COMPLETE standard 

here at Dansk Standard.

Machinery Directive

e is a headline

WARNING!
This description is only a abstract.
The full compliance: Kopen it complete standard, and translate the requirements into practice.

They are a headline

A product may be covered by several EU directives or regulations. You must then meet all requirements before you can affix the CE mark.

In the following we limit ourselves to labeling according to the Machinery Directive:

1. Read the Machinery Directive / Machinery Regulation
a) Clarify: Is the machine covered by Machinery Directive 2006/42/EC? 
b) Map other relevant directives:
EMC, low voltage, ATEX).
c) Select harmonized standards as proof of conformity.

2. Conduct Risk Assessment
a) Apply EN ISO 12100.
b) Determine the machine's limits.
c) Identify Hazards.
d) Assess and Reduce Risks.
e) Document remaining Risks and Warnings,
The result is the basis for: Safety design, Instructions for use and CE documentation.

3. Perform Construction with implemented risk reduction
a) Apply Inherently Secure design solutions.
b) Provide the structure with: Technical protective equipment; Shielding, Emergency stop, Interlocks.
c) As described in EN ISO 12100 and DS/EN ISO 20607: Provide the machine with User Information and Warnings:
d) As described in EN ISO 13849-1/-2 (PL) or IEC 62061 (SIL): Verify and validate according to relevant standards.

4. Prepare Instructions for Use
a) Apply DS/EN ISO 20607:2019
b) On the machine's marketing language:
Prepare SECTIONS: Purpose, Target group, Safety information (residual risks, emergency procedures), Installation, Commissioning, Operation, Maintenance/Service, Troubleshooting and Disposal.

NB! The instructions for use must be included in the technical dossier and be completed before CE marking.

5. CE marking
a) Elaborate EU Declaration of Conformity with reference to the Machinery Directive/Regulation and the standards used.
b) Saml technical dossier: Risk assessment, Drawings, Calculations, Test protocols and Instructions for use.
c) Apply CE marked.
d) Store the dossier for at least 10 years after the last unit produced.