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Table of Contents
Table of Contents
EU regulations & directives
The Machinery Regulation (EU) 2023/1230
Learn what the EU's new machinery regulation 2023/1230 means, how it differs from the Machinery Directive 2006/42/EC, and what you need to do to meet the requirements. Step-by-step guide from Noex Academy.
What does the new EU regulation for machinery mean?
The EU's new Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC and becomes binding law throughout the EU from 20 January 2027. It changes the playing field for how machinery is designed, documented, and CE marked. The focus shifts to digital safety, AI-controlled systems, and continuous risk management.
Background - why a new regulation?
The Machinery Directive has been the foundation for European machinery safety since 1989, but the currently applicable revised version 2006/42/EC was decided in 2006 and became binding from December 2009. However, the industry has changed - automation, remote control, and AI have necessitated a new regulatory framework. The new regulation is a legally binding regulation (as opposed to a directive) and applies directly in all member states without national implementation.
It complements several other EU laws, including:
Cyber Resilience Act (CRA)
AI Act
LVD, EMC, and RED directives
The biggest changes (overview for all target groups)
Area | Newness in the Machinery Regulation | What it means |
|---|---|---|
Digital documentation | Technical files can be entirely digital (PDF, cloud, or stored in Noex) | You avoid paper requirements but must ensure access, version control, and traceability |
AI and machine learning | AI systems are considered part of the safety function | You must be able to demonstrate that the algorithm is controllable and predictable |
Updated risk classes | "High-risk machines" are introduced (Annex I) | Requires assessment by a notified body before CE marking |
Distribution of responsibilities | Clearer requirements for manufacturers, importers, and distributors | You must be able to prove who did what - and when |
Cybersecurity | New requirement for protection against digital manipulation | This also applies to machines without internet connection if they can be affected via software |
Pedagogical walkthrough - how the Machinery Regulation works
Identify if your product is covered
All products defined as machinery, safety components, lifting accessories, chains, ropes, belts or interchangeable equipment are covered.
Tip: Many believe that small automated devices (e.g., robotic cells or integrated modules) do not count - but they almost always do according to Article 3.
Classify risk level
The regulation divides machines into two categories:
Annex I - Section A - High-risk machines: requires external assessment by a notified body.
Annex I - Section B - Risk machines: self-assessment is usually sufficient, but you may need external assessment in two situations.
If you use a harmonized standard only partially, or not at all
If you do not meet all relevant harmonized standards that provide presumption of conformity, internal control is not sufficient.
In that case, you must use one of the following modules:
EU-type examination (module B) and
Module C (conformity with type) or
Module E (quality assurance) or
Module F (product verification)
These involve external bodies.
If the machine includes safety components that fall under Annex I A
Example: AI-based safety functions.
In that case, an external body may become mandatory even if the machine itself is listed in Section B.
Perform risk assessment and design protection
Use EN ISO 12100 as methodological support.
Identify hazards
Assess probability and severity
Take protective measures in order: inherent safety → protection → information
Establish technical documentation
According to Article 10.3, the manufacturer must store all documentation for at least 10 years.
The documentation can be entirely digital and should include:
Description of the machine/product and its intended use.
Risk assessment, including:
The fundamental health and safety requirements (found in Noex).
Protective measures and remaining risks.
Drawings and schematics (construction, manufacturing, components, circuits).
Explanations needed to understand drawings and function.
Applicable standards/GS, including which parts were used in partial application.
Other technical specifications when standards have not been followed or only partially followed.
Calculations, testing, trials, and controls that verify conformity.
Manufacturing methods that ensure conformity with construction.
User manual and user information according to Annex III point 1.7.4.
EU declaration of incorporation + installation instructions (for partially completed machine).
EU declarations of conformity for integrated products covered by other EU legislation.
Internal procedures for series production to ensure continued conformity.
Source code or programming logic for safety-related software (upon justified request).
For sensor-controlled/remote-controlled/autonomous products:
System characteristics, capabilities, limitations, as well as data, testing, and validation processes.
Test and inspection results showing that the product can be assembled and put into operation without risk.
CE mark and declare conformity
When the requirements are met, you must affix the CE marking visibly on the product and establish a EU declaration of conformity.
Tip: Specify the correct legislation - write "(EU) 2023/1230" instead of the old "2006/42/EC".
Technical review - Machinery Regulation for industry professionals
Fundamental health and safety requirements (EHSR)
Annex III lists the essential requirements for safe design. Examples of new features:
EHSR 1.1.9: Protection against distortion, an entirely new requirement.
EHSR 1.2.1: Protection against external influence, logging of security software and interference as well as specific requirements for control systems with self-developing behavior.
EHSR 1.2.6: Inclusion of communication networks.
Integration of AI systems
If a machine uses AI for control, decision-making, or adaptation, it must:
The system must be predictable - no "black-box logic".
The risk assessment must include how algorithms affect safety functions.
The machine must always be correctable to maintain its inherent safety.
Requirements for digital documentation
The regulation allows digital archiving but requires:
Accessibility: the notified body or authority must be able to access it directly.
Version control: all updates must be time-stamped.
Authenticity: data must be protected against alteration (e.g., through digital signing or version control in Noex platform)
Roles and responsibilities
Role | Responsibility |
|---|---|
Manufacturer | Conducts risk assessment, documentation, and CE marking |
Importer | Ensures that the manufacturer has met the requirements |
Distributor | Handles storage, labeling, and informs of risks |
Integrator | Responsible for the overall system if multiple machines are connected |
Important: When you build a production line of multiple machines, you become a new manufacturer according to Article 10.
Consequences of not following the Machinery Regulation
CE marking can be declared invalid
Sales ban within the EU
Recalls and sanctions (up to 10% of annual turnover)
Civil liability in the event of accidents
Example: A company may be prohibited from selling machines with integrated AI control if it cannot prove that the AI algorithm has been validated according to Annex III - even if the product is otherwise CE marked.
Common mistakes to avoid
Using old references to the Machinery Directive in the documentation
Confusing "high-risk machine" with "dangerous machine" - the classification is legal
Underrating cybersecurity requirements
Failing to update user manuals during software updates
FAQ Machinery Regulation (EU) 2023/1230
When does the Machinery Regulation come into effect?
Answer: It will apply from 20 January 2027, but companies should adapt by 2026 at the latest.Do I need to do a new CE marking for existing machines?
Answer: No, not retroactively - but in case of modifications, integration, or new versions, it must meet the regulation's requirements.What happens if I do not have digital documentation?
Answer: You risk sales stoppage and lack of traceability during inspection. The regulation requires secure and accessible storage for at least 10 years.
What does the new EU regulation for machinery mean?
The EU's new Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC and becomes binding law throughout the EU from 20 January 2027. It changes the playing field for how machinery is designed, documented, and CE marked. The focus shifts to digital safety, AI-controlled systems, and continuous risk management.
Background - why a new regulation?
The Machinery Directive has been the foundation for European machinery safety since 1989, but the currently applicable revised version 2006/42/EC was decided in 2006 and became binding from December 2009. However, the industry has changed - automation, remote control, and AI have necessitated a new regulatory framework. The new regulation is a legally binding regulation (as opposed to a directive) and applies directly in all member states without national implementation.
It complements several other EU laws, including:
Cyber Resilience Act (CRA)
AI Act
LVD, EMC, and RED directives
The biggest changes (overview for all target groups)
Area | Newness in the Machinery Regulation | What it means |
|---|---|---|
Digital documentation | Technical files can be entirely digital (PDF, cloud, or stored in Noex) | You avoid paper requirements but must ensure access, version control, and traceability |
AI and machine learning | AI systems are considered part of the safety function | You must be able to demonstrate that the algorithm is controllable and predictable |
Updated risk classes | "High-risk machines" are introduced (Annex I) | Requires assessment by a notified body before CE marking |
Distribution of responsibilities | Clearer requirements for manufacturers, importers, and distributors | You must be able to prove who did what - and when |
Cybersecurity | New requirement for protection against digital manipulation | This also applies to machines without internet connection if they can be affected via software |
Pedagogical walkthrough - how the Machinery Regulation works
Identify if your product is covered
All products defined as machinery, safety components, lifting accessories, chains, ropes, belts or interchangeable equipment are covered.
Tip: Many believe that small automated devices (e.g., robotic cells or integrated modules) do not count - but they almost always do according to Article 3.
The regulation divides machines into two categories:
Annex I - Section A - High-risk machines: requires external assessment by a notified body.
Annex I - Section B - Risk machines: self-assessment is usually sufficient, but you may need external assessment in two situations.
If you use a harmonized standard only partially, or not at all
If you do not meet all relevant harmonized standards that provide presumption of conformity, internal control is not sufficient.
In that case, you must use one of the following modules:
EU-type examination (module B) and
Module C (conformity with type) or
Module E (quality assurance) or
Module F (product verification)
These involve external bodies.
If the machine includes safety components that fall under Annex I A
Example: AI-based safety functions.
In that case, an external body may become mandatory even if the machine itself is listed in Section B.
Use EN ISO 12100 as methodological support.
Identify hazards
Assess probability and severity
Take protective measures in order: inherent safety → protection → information
According to Article 10.3, the manufacturer must store all documentation for at least 10 years.
The documentation can be entirely digital and should include:
Description of the machine/product and its intended use.
Risk assessment, including:
The fundamental health and safety requirements (found in Noex).
Protective measures and remaining risks.
Drawings and schematics (construction, manufacturing, components, circuits).
Explanations needed to understand drawings and function.
Applicable standards/GS, including which parts were used in partial application.
Other technical specifications when standards have not been followed or only partially followed.
Calculations, testing, trials, and controls that verify conformity.
Manufacturing methods that ensure conformity with construction.
User manual and user information according to Annex III point 1.7.4.
EU declaration of incorporation + installation instructions (for partially completed machine).
EU declarations of conformity for integrated products covered by other EU legislation.
Internal procedures for series production to ensure continued conformity.
Source code or programming logic for safety-related software (upon justified request).
For sensor-controlled/remote-controlled/autonomous products:
System characteristics, capabilities, limitations, as well as data, testing, and validation processes.
Test and inspection results showing that the product can be assembled and put into operation without risk.
When the requirements are met, you must affix the CE marking visibly on the product and establish a EU declaration of conformity.
Tip: Specify the correct legislation - write "(EU) 2023/1230" instead of the old "2006/42/EC".
Technical review - Machinery Regulation for industry professionals
Fundamental health and safety requirements (EHSR)
Annex III lists the essential requirements for safe design. Examples of new features:
EHSR 1.1.9: Protection against distortion, an entirely new requirement.
EHSR 1.2.1: Protection against external influence, logging of security software and interference as well as specific requirements for control systems with self-developing behavior.
EHSR 1.2.6: Inclusion of communication networks.
Integration of AI systems
If a machine uses AI for control, decision-making, or adaptation, it must:
The system must be predictable - no "black-box logic".
The risk assessment must include how algorithms affect safety functions.
The machine must always be correctable to maintain its inherent safety.
Requirements for digital documentation
The regulation allows digital archiving but requires:
Accessibility: the notified body or authority must be able to access it directly.
Version control: all updates must be time-stamped.
Authenticity: data must be protected against alteration (e.g., through digital signing or version control in Noex platform)
Roles and responsibilities
Role | Responsibility |
|---|---|
Manufacturer | Conducts risk assessment, documentation, and CE marking |
Importer | Ensures that the manufacturer has met the requirements |
Distributor | Handles storage, labeling, and informs of risks |
Integrator | Responsible for the overall system if multiple machines are connected |
Important: When you build a production line of multiple machines, you become a new manufacturer according to Article 10.
Consequences of not following the Machinery Regulation
CE marking can be declared invalid
Sales ban within the EU
Recalls and sanctions (up to 10% of annual turnover)
Civil liability in the event of accidents
Example: A company may be prohibited from selling machines with integrated AI control if it cannot prove that the AI algorithm has been validated according to Annex III - even if the product is otherwise CE marked.
Common mistakes to avoid
Using old references to the Machinery Directive in the documentation
Confusing "high-risk machine" with "dangerous machine" - the classification is legal
Underrating cybersecurity requirements
Failing to update user manuals during software updates
FAQ Machinery Regulation (EU) 2023/1230
When does the Machinery Regulation come into effect?
Answer: It will apply from 20 January 2027, but companies should adapt by 2026 at the latest.Do I need to do a new CE marking for existing machines?
Answer: No, not retroactively - but in case of modifications, integration, or new versions, it must meet the regulation's requirements.What happens if I do not have digital documentation?
Answer: You risk sales stoppage and lack of traceability during inspection. The regulation requires secure and accessible storage for at least 10 years.
What does the new EU regulation for machinery mean?
The EU's new Machinery Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC and becomes binding law throughout the EU from 20 January 2027. It changes the playing field for how machinery is designed, documented, and CE marked. The focus shifts to digital safety, AI-controlled systems, and continuous risk management.
Background - why a new regulation?
The Machinery Directive has been the foundation for European machinery safety since 1989, but the currently applicable revised version 2006/42/EC was decided in 2006 and became binding from December 2009. However, the industry has changed - automation, remote control, and AI have necessitated a new regulatory framework. The new regulation is a legally binding regulation (as opposed to a directive) and applies directly in all member states without national implementation.
It complements several other EU laws, including:
Cyber Resilience Act (CRA)
AI Act
LVD, EMC, and RED directives
The biggest changes (overview for all target groups)
Area | Newness in the Machinery Regulation | What it means |
|---|---|---|
Digital documentation | Technical files can be entirely digital (PDF, cloud, or stored in Noex) | You avoid paper requirements but must ensure access, version control, and traceability |
AI and machine learning | AI systems are considered part of the safety function | You must be able to demonstrate that the algorithm is controllable and predictable |
Updated risk classes | "High-risk machines" are introduced (Annex I) | Requires assessment by a notified body before CE marking |
Distribution of responsibilities | Clearer requirements for manufacturers, importers, and distributors | You must be able to prove who did what - and when |
Cybersecurity | New requirement for protection against digital manipulation | This also applies to machines without internet connection if they can be affected via software |
Pedagogical walkthrough - how the Machinery Regulation works
Identify if your product is covered
All products defined as machinery, safety components, lifting accessories, chains, ropes, belts or interchangeable equipment are covered.
Tip: Many believe that small automated devices (e.g., robotic cells or integrated modules) do not count - but they almost always do according to Article 3.
The regulation divides machines into two categories:
Annex I - Section A - High-risk machines: requires external assessment by a notified body.
Annex I - Section B - Risk machines: self-assessment is usually sufficient, but you may need external assessment in two situations.
If you use a harmonized standard only partially, or not at all
If you do not meet all relevant harmonized standards that provide presumption of conformity, internal control is not sufficient.
In that case, you must use one of the following modules:
EU-type examination (module B) and
Module C (conformity with type) or
Module E (quality assurance) or
Module F (product verification)
These involve external bodies.
If the machine includes safety components that fall under Annex I A
Example: AI-based safety functions.
In that case, an external body may become mandatory even if the machine itself is listed in Section B.
Use EN ISO 12100 as methodological support.
Identify hazards
Assess probability and severity
Take protective measures in order: inherent safety → protection → information
According to Article 10.3, the manufacturer must store all documentation for at least 10 years.
The documentation can be entirely digital and should include:
Description of the machine/product and its intended use.
Risk assessment, including:
The fundamental health and safety requirements (found in Noex).
Protective measures and remaining risks.
Drawings and schematics (construction, manufacturing, components, circuits).
Explanations needed to understand drawings and function.
Applicable standards/GS, including which parts were used in partial application.
Other technical specifications when standards have not been followed or only partially followed.
Calculations, testing, trials, and controls that verify conformity.
Manufacturing methods that ensure conformity with construction.
User manual and user information according to Annex III point 1.7.4.
EU declaration of incorporation + installation instructions (for partially completed machine).
EU declarations of conformity for integrated products covered by other EU legislation.
Internal procedures for series production to ensure continued conformity.
Source code or programming logic for safety-related software (upon justified request).
For sensor-controlled/remote-controlled/autonomous products:
System characteristics, capabilities, limitations, as well as data, testing, and validation processes.
Test and inspection results showing that the product can be assembled and put into operation without risk.
When the requirements are met, you must affix the CE marking visibly on the product and establish a EU declaration of conformity.
Tip: Specify the correct legislation - write "(EU) 2023/1230" instead of the old "2006/42/EC".
Technical review - Machinery Regulation for industry professionals
Fundamental health and safety requirements (EHSR)
Annex III lists the essential requirements for safe design. Examples of new features:
EHSR 1.1.9: Protection against distortion, an entirely new requirement.
EHSR 1.2.1: Protection against external influence, logging of security software and interference as well as specific requirements for control systems with self-developing behavior.
EHSR 1.2.6: Inclusion of communication networks.
Integration of AI systems
If a machine uses AI for control, decision-making, or adaptation, it must:
The system must be predictable - no "black-box logic".
The risk assessment must include how algorithms affect safety functions.
The machine must always be correctable to maintain its inherent safety.
Requirements for digital documentation
The regulation allows digital archiving but requires:
Accessibility: the notified body or authority must be able to access it directly.
Version control: all updates must be time-stamped.
Authenticity: data must be protected against alteration (e.g., through digital signing or version control in Noex platform)
Roles and responsibilities
Role | Responsibility |
|---|---|
Manufacturer | Conducts risk assessment, documentation, and CE marking |
Importer | Ensures that the manufacturer has met the requirements |
Distributor | Handles storage, labeling, and informs of risks |
Integrator | Responsible for the overall system if multiple machines are connected |
Important: When you build a production line of multiple machines, you become a new manufacturer according to Article 10.
Consequences of not following the Machinery Regulation
CE marking can be declared invalid
Sales ban within the EU
Recalls and sanctions (up to 10% of annual turnover)
Civil liability in the event of accidents
Example: A company may be prohibited from selling machines with integrated AI control if it cannot prove that the AI algorithm has been validated according to Annex III - even if the product is otherwise CE marked.
Common mistakes to avoid
Using old references to the Machinery Directive in the documentation
Confusing "high-risk machine" with "dangerous machine" - the classification is legal
Underrating cybersecurity requirements
Failing to update user manuals during software updates
FAQ Machinery Regulation (EU) 2023/1230
When does the Machinery Regulation come into effect?
Answer: It will apply from 20 January 2027, but companies should adapt by 2026 at the latest.Do I need to do a new CE marking for existing machines?
Answer: No, not retroactively - but in case of modifications, integration, or new versions, it must meet the regulation's requirements.What happens if I do not have digital documentation?
Answer: You risk sales stoppage and lack of traceability during inspection. The regulation requires secure and accessible storage for at least 10 years.
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