European machinery safety regulation is undergoing one of its most important changes in decades. Regulation (EU) 2023/1230 introduces a modernised legal framework for machinery and related products and will replace the long-standing Machinery Directive 2006/42/EC.
The fundamental objective remains familiar: machinery placed on the European market must be designed and manufactured so that it can be used safely throughout its intended lifecycle. The new Regulation, however, responds to an increasingly digital machinery environment involving software, connected systems, autonomous behaviour, artificial intelligence and cybersecurity-related safety risks.
For manufacturers, importers, system integrators and organisations modifying existing machinery, compliance therefore involves considerably more than fitting guards around moving parts. Risk assessment, functional safety, control-system design, software, instructions, technical documentation, conformity assessment and production control all form part of a defensible CE marking programme.
This GAR Insight explains the transition from Directive 2006/42/EC to Regulation (EU) 2023/1230 and provides a practical roadmap for machinery manufacturers preparing for the new European framework.
Navigate This Article
Explore the Regulation’s transition, machinery scope, essential requirements, risk assessment, software, substantial modification, conformity assessment, technical documentation and CE marking.
From the Machinery Directive to the Machinery Regulation
Regulation (EU) 2023/1230 replaces Directive 2006/42/EC as the principal European machinery safety framework.
The change from a Directive to a Regulation is significant. A Regulation is directly applicable across EU Member States rather than requiring national transposition in the same manner as a Directive.
Manufacturers preparing machinery for European market placement around the transition period should therefore establish which legal framework applies based on the relevant date of market placement and applicable transitional provisions.
Machinery & Related Products
The Regulation covers machinery and a defined group of related products. Understanding product classification is important because the precise obligations and conformity route can depend on the nature of the product.
Machinery
Assemblies of linked parts or components with at least one moving element, generally joined together for a specific application.
Interchangeable Equipment
Equipment assembled with machinery or a tractor after commissioning in order to change its function or provide a new function.
Safety Components
Components performing a safety function where failure or malfunction can endanger persons.
Lifting Accessories
Components or equipment allowing a load to be held and used between lifting machinery and the load.
Chains, Ropes & Webbing
Products designed and constructed for lifting purposes as part of lifting machinery or lifting accessories.
Transmission Devices
Removable mechanical transmission devices used between self-propelled machinery or tractors and other machinery.
The framework also addresses partly completed machinery, which requires a different documentation and incorporation route because it is not intended to function independently as complete machinery.
Risk Assessment Is the Foundation of Machinery Compliance
Machinery conformity begins with systematic identification of hazards and assessment of the risks associated with the machinery throughout reasonably foreseeable phases of its lifecycle.
Define Limits
Establish intended use, operating modes, users and foreseeable misuse.
Identify Hazards
Mechanical, electrical, thermal, ergonomic and other hazards.
Estimate Risk
Consider severity and probability associated with each hazard.
Evaluate Risk
Determine whether further risk reduction is necessary.
Safe Design
Eliminate or reduce hazards through inherently safe design.
Protect
Apply guards, protective devices and control measures.
Inform
Address residual risks through instructions and warnings.
Document
Maintain traceable evidence of the risk-reduction process.
Essential Health & Safety Requirements
Annex III establishes the Essential Health and Safety Requirements that form the technical backbone of the Regulation.
Mechanical Hazards
Crushing, shearing, cutting, entanglement, drawing-in, impact, ejection and other risks from moving machinery.
Guards & Protective Devices
Protective systems must be suitable for the hazard and designed so that they do not create additional risks.
Control Systems
Control-system faults should not lead to hazardous situations and safety functions should perform reliably.
Electrical Hazards
Machinery should protect persons against electrical risks arising during intended use and foreseeable conditions.
Temperature & Fire
Risks arising from extreme temperatures, fire or overheating must be adequately controlled.
Noise & Vibration
Risks from noise and vibration should be reduced to the lowest level reasonably achievable through design and protective measures.
Ergonomics
Machinery should consider operator posture, movement, physical characteristics and foreseeable human interaction.
Maintenance & Access
Adjustment, cleaning and maintenance activities should be possible without exposing persons to unnecessary risk.
Control Systems & Safety Functions
Modern machinery depends increasingly on electrical, electronic and programmable control systems to manage safety functions.
Emergency Stop
Emergency-stop systems should achieve the required safe response without introducing additional hazards.
Interlocking
Guards and access systems may require interlocking to prevent hazardous machine operation under unsafe conditions.
Safe Stop Functions
Drives and machinery may require defined stopping behaviour when safety functions are initiated.
Fault Behaviour
Single faults or foreseeable failure conditions should not create unacceptable hazardous machine behaviour.
Standards such as the EN ISO 13849 family and IEC/EN 62061 can be relevant to safety-related parts of machinery control systems depending on the architecture and application.
Software, AI & Cybersecurity-Related Safety
Machinery is increasingly software-defined. Safety-related behaviour can depend on embedded software, programmable controllers, remote connections, sensor systems and adaptive or autonomous functions.
Regulation (EU) 2023/1230 explicitly modernises the safety framework to address risks arising from these digital technologies.
Safety Software
Software controlling safety functions should be appropriately designed, validated and protected against foreseeable faults.
Autonomous Behaviour
Machinery incorporating autonomous or evolving behaviour requires careful consideration of the limits of safe operation.
Connected Machinery
Remote access and connectivity should not enable hazardous modification of safety-related machine behaviour.
Cybersecurity & Safety
Protection against corruption or manipulation becomes relevant where such interference can lead to unsafe machine operation.
Substantial Modification & New Manufacturer Responsibilities
One of the important clarifications in Regulation (EU) 2023/1230 concerns machinery that is substantially modified after it has been placed on the market or put into service.
A significant physical or digital modification that was not foreseen by the original manufacturer and affects machinery safety may create new conformity responsibilities for the person performing that modification.
Physical Modification
Changes to structures, drives, guards, tooling, operating speeds or other machinery characteristics can alter established risk.
Digital Modification
Changes to software, logic, control systems or safety functions can materially change machine behaviour even without major mechanical alterations.
Changed Safety Function
Modifications affecting safety functions should be assessed against the resulting hazards and conformity requirements.
Changed Intended Use
Changing the purpose or operating limits of machinery can invalidate assumptions underlying the original risk assessment.
Harmonised Machinery Standards
Harmonised standards provide practical technical routes for demonstrating conformity with applicable machinery safety requirements.
Type A Standards
Basic machinery safety concepts, principles and design methodology applicable broadly across machinery.
Type B Standards
Standards dealing with particular safety aspects or safeguards that can apply across multiple machinery categories.
Type C Standards
Detailed standards addressing specific machine types or groups of machinery.
| Example Area | Typical Standards Framework |
|---|---|
| Risk Assessment | EN ISO 12100 |
| Safety-Related Control Systems | EN ISO 13849 family / EN IEC 62061 |
| Electrical Equipment of Machines | EN IEC 60204 family |
| Guards | Relevant machinery guarding standards |
| Interlocking Devices | Relevant interlocking and protective-device standards |
| Emergency Stop | Relevant emergency-stop design standards |
Higher-Risk Machinery Categories
Regulation (EU) 2023/1230 identifies particular machinery and related products in Annex I for which the conformity assessment regime is more prescriptive because of their risk characteristics.
Annex I is divided into categories for which different conformity assessment possibilities apply. For the highest-risk categories listed in Part A, manufacturer self-assessment alone is not available.
Annex I Part A
Certain higher-risk machinery or safety products require conformity assessment involving an appropriately notified third party.
Annex I Part B
Other listed categories can have different conformity assessment possibilities depending on the standards applied and the selected route.
The Regulation also provides mechanisms allowing the Commission to update Annex I based on accident data, technological developments and other evidence concerning machinery risk.
Selecting the Correct Machinery Conformity Route
The conformity assessment procedure depends on the machinery or related product, its classification and whether it falls within Annex I.
Internal Production Control
For machinery where the Regulation permits manufacturer assessment, conformity may be established through internal production control.
EU-Type Examination
A Notified Body examines the technical design of applicable machinery and verifies that it satisfies the relevant requirements.
Full Quality Assurance
A Notified Body assesses and monitors the manufacturer’s quality system where this conformity route is selected and permitted.
Unit Verification
Individual machinery can be assessed through a unit-verification route where provided for by the Regulation.
Classify
Determine machinery type and Annex I status.
Assess Risk
Identify hazards and required risk reduction.
Select Standards
Identify applicable harmonised standards.
Select Route
Determine the legally available conformity procedure.
Verify
Complete testing, calculations and safety validation.
Document
Compile the machinery technical documentation.
Declare
Issue the EU Declaration of Conformity.
CE Mark
Affix CE marking before market placement.
Machinery Technical Documentation
The technical documentation provides the evidence needed to demonstrate that machinery or a related product satisfies the applicable Regulation.
Instructions, Digital Documentation & Safety Information
The Machinery Regulation modernises the way instructions and other product information can be supplied, including greater use of digital documentation subject to the conditions established by the Regulation.
Installation
Instructions should describe requirements necessary for safe installation and integration.
Operation
Information should explain intended operating modes, limits and residual risks.
Maintenance
Safe inspection, adjustment, cleaning, replacement and maintenance procedures should be addressed.
Digital Access
Where digital instructions are provided, applicable requirements for accessibility and availability should be satisfied.
EU Declaration of Conformity & CE Marking
Once conformity has been established through the correct procedure, the manufacturer prepares the EU Declaration of Conformity and affixes the CE marking to machinery or the related product.
Manufacturer
Identify the manufacturer and the relevant responsible economic operator.
Machinery Identification
Clearly identify the machine, model, type and other relevant traceability information.
Applicable Legislation
Identify the Machinery Regulation and other applicable EU harmonisation legislation.
Standards
Identify relevant harmonised standards and other specifications where applicable.
Machinery may also fall within other European legislation such as EMC, ATEX, Pressure Equipment, Radio Equipment or RoHS depending on the machine’s design and functions.
From Machine Design to Demonstrable Safety
Machinery CE marking is ultimately the conclusion of an engineering safety process. The most successful compliance programmes integrate risk assessment into design rather than treating conformity assessment as an inspection performed after machinery construction is complete.
Regulation (EU) 2023/1230 strengthens this principle while adapting European machinery rules to connected, software-controlled and increasingly autonomous equipment.
The Engineering Question
Have hazards been eliminated or reduced through suitable design, safeguarding and safety-related controls?
The Compliance Question
Can the manufacturer demonstrate through traceable evidence that the complete machinery satisfies all applicable legal requirements?