CE Marking for Machinery – Conformity Assessment, Technical Documentation and EU Market Access

What is CE marking for machinery?

CE marking is a conformity marking indicating that a product has been assessed by the manufacturer and found to meet applicable EU safety, health and environmental protection requirements. For machinery, CE marking allows products that comply with EU requirements to be placed on the European market.

CE marking is not a quality mark, commercial approval, origin label or voluntary marketing symbol. It is a regulatory marking required for products covered by EU legislation that provides for CE marking.

For machinery, CE marking demonstrates that the manufacturer has taken responsibility for conformity with applicable requirements and has completed the required conformity assessment process.

When is CE marking required for machinery?

CE marking is required when machinery falls within the scope of EU machinery legislation and is placed on the EU market or put into service for the first time.

CE marking may be required for:

• industrial machinery,
• production machinery,
• automated machinery,
• lifting machinery,
• packaging machinery,
• woodworking machinery,
• metalworking machinery,
• food processing machinery,
• robotic systems and automated production equipment,
• interchangeable equipment,
• safety components,
• lifting accessories,
• chains, ropes and webbing,
• removable mechanical transmission devices,
• partly completed machinery, where specific documentation and declaration requirements apply.

The exact legal requirements depend on the product type, intended use, technical characteristics and applicable EU legislation.

Who is responsible for CE marking of machinery?

The manufacturer is primarily responsible for ensuring that machinery complies with applicable EU requirements before it is placed on the market or put into service.

The manufacturer’s responsibilities may include:

• identifying applicable EU legislation,
• identifying applicable essential health and safety requirements,
• performing risk assessment,
• designing and manufacturing machinery in accordance with applicable requirements,
• preparing technical documentation,
• applying relevant harmonised standards where appropriate,
• carrying out the conformity assessment procedure,
• involving a notified body where required,
• drawing up the EU Declaration of Conformity,
• affixing the CE marking correctly.

Importers, distributors, authorised representatives and entities substantially modifying machinery may also have legal obligations under EU product legislation, depending on their role in the supply chain.

Which EU legislation applies to CE marking for machinery?

The main legal framework for machinery CE marking is the Machinery Directive 2006/42/EC. This Directive sets requirements for the design and construction of machinery placed on the EU market or put into service.

From 20 January 2027, Regulation (EU) 2023/1230 on machinery will apply and replace the Machinery Directive. The new Regulation introduces updated requirements, including changes related to high-risk machinery, digital documentation, cybersecurity aspects, artificial intelligence-related risks and substantial modification.

Depending on the machinery and its components, other EU legislation may also apply, including:

• Low Voltage Directive,
• Electromagnetic Compatibility Directive,
• Pressure Equipment Directive,
• ATEX Directive,
• Radio Equipment Directive,
• RoHS Directive,
• Outdoor Noise Directive,
• Construction Products Regulation, where relevant,
• other product-specific EU harmonisation legislation.

Correct identification of all applicable legislation is one of the first steps in the CE marking process.

Machinery Directive 2006/42/EC and Regulation (EU) 2023/1230

The Machinery Directive 2006/42/EC remains the key legal act for machinery until the new Machinery Regulation becomes applicable. Regulation (EU) 2023/1230 was adopted to update the legal framework for machinery and address technological, market and safety developments.

Important dates include:

• Machinery Regulation (EU) 2023/1230 was published in 2023,
• the Regulation will apply from 20 January 2027,
• Directive 2006/42/EC will be repealed when the new Regulation becomes applicable,
• manufacturers should prepare for the change before the application date.

The new Regulation is directly applicable in EU Member States and is expected to strengthen consistency in the application of machinery safety requirements across the EU.

What does CE marking confirm?

CE marking confirms that machinery has been assessed for conformity with applicable EU requirements before being placed on the market or put into service.

CE marking may confirm that:

• the required conformity assessment procedure has been carried out,
• the machinery complies with applicable essential health and safety requirements,
• technical documentation has been prepared,
• the EU Declaration of Conformity has been drawn up,
• the manufacturer has taken responsibility for product conformity,
• a notified body has been involved where required by legislation.

CE marking does not automatically mean that a notified body has assessed the machinery. Notified body involvement is required only for specific machinery categories and conformity assessment routes defined by applicable legislation.

How does the machinery conformity assessment process work?

The conformity assessment process for machinery is the structured procedure used to demonstrate compliance with applicable EU requirements.

A typical CE marking process for machinery includes:

1. identifying whether the product is machinery, partly completed machinery, interchangeable equipment or another product category,
2. identifying all applicable EU legislation,
3. identifying applicable essential health and safety requirements,
4. conducting risk assessment and risk reduction,
5. selecting applicable harmonised standards,
6. designing and manufacturing machinery according to relevant requirements,
7. performing tests, inspections or verifications where required,
8. preparing technical documentation,
9. selecting the appropriate conformity assessment procedure,
10. involving a notified body where required,
11. drawing up the EU Declaration of Conformity,
12. affixing the CE marking to the machinery.

Risk assessment for machinery

Risk assessment is a central part of machinery conformity assessment. It allows the manufacturer to identify hazards, estimate and evaluate risks, and define protective measures to reduce risks to an acceptable level.

Risk assessment may include analysis of:

• mechanical hazards,
• electrical hazards,
• thermal hazards,
• noise and vibration,
• ergonomic risks,
• control system failures,
• unexpected start-up,
• maintenance and cleaning activities,
• human-machine interaction,
• foreseeable misuse,
• software-related and automation-related hazards,
• cybersecurity-related risks where relevant.

The results of risk assessment should be reflected in design decisions, protective measures, instructions for use and technical documentation.

Essential health and safety requirements for machinery

Essential health and safety requirements define the safety objectives that machinery must meet before it can be placed on the EU market.

These requirements may relate to:

• mechanical stability and strength,
• safe control systems,
• guards and protective devices,
• emergency stop functions,
• protection against electrical risks,
• prevention of fire and explosion risks,
• noise and vibration reduction,
• ergonomics,
• safe maintenance and adjustment,
• warnings, markings and instructions,
• residual risks and user information.

The manufacturer must determine which essential health and safety requirements apply to the machinery and demonstrate how they have been addressed.

Technical documentation for machinery CE marking

Technical documentation is one of the key elements of the CE marking process. It demonstrates how the machinery has been designed, manufactured and assessed for conformity with applicable requirements.

Technical documentation may include:

• general description of the machinery,
• design and manufacturing drawings,
• schematics of control circuits,
• risk assessment documentation,
• list of applicable essential health and safety requirements,
• list of harmonised standards or technical specifications applied,
• test reports and inspection results,
• calculations and verification results,
• instructions for use,
• maintenance instructions,
• declarations for incorporated components,
• EU Declaration of Conformity.

The technical file must be sufficiently complete to allow assessment of the machinery’s conformity with applicable EU requirements.

EU Declaration of Conformity for machinery

The EU Declaration of Conformity is the formal document in which the manufacturer declares that the machinery complies with all applicable EU legislation.

The Declaration of Conformity typically includes:

• manufacturer’s name and address,
• identification of the machinery,
• statement of conformity with applicable legislation,
• references to relevant harmonised standards,
• details of the notified body where applicable,
• name and signature of the authorised person,
• place and date of issue.

The CE marking should not be affixed until the required conformity assessment has been completed and the Declaration of Conformity has been drawn up.

When is a notified body required for machinery CE marking?

For many machinery categories, the manufacturer may carry out conformity assessment under internal production control. However, notified body involvement may be required for certain machinery categories or specific conformity assessment procedures.

A notified body may be required where machinery falls within categories listed in the applicable legislation and the selected conformity assessment route requires third-party assessment.

Notified body involvement may include:

• EU-type examination,
• assessment of technical documentation,
• quality assurance assessment,
• verification according to the applicable conformity assessment module,
• certification activities within the notified scope.

The manufacturer must determine whether notified body involvement is required for the machinery concerned.

Machinery categories requiring special attention

Certain machinery categories may require additional assessment due to higher safety risks, specific technical characteristics or specific legal classification.

Examples may include:

• presses and press brakes,
• woodworking machinery,
• lifting machinery,
• machinery for underground work,
• machinery with safety-related control systems,
• removable mechanical transmission devices,
• safety components,
• machinery using AI or autonomous functions,
• machinery connected to digital networks where cybersecurity may influence safety.

The applicable conformity assessment route depends on the machinery type, applied standards and legal framework in force at the time of placing on the market.

CE marking for partly completed machinery

Partly completed machinery is equipment that cannot perform a specific application on its own and is intended to be incorporated into other machinery or assembled with other equipment.

Partly completed machinery is not normally CE marked under the same rules as complete machinery. Instead, specific documentation and declaration requirements apply.

Documentation for partly completed machinery may include:

• relevant technical documentation,
• assembly instructions,
• Declaration of Incorporation,
• information about requirements applied and fulfilled.

The final machinery manufacturer is responsible for ensuring conformity of the complete machinery before CE marking is affixed.

CE marking for used machinery

Used machinery may raise specific questions regarding CE marking, especially when it is imported into the EU, substantially modified, rebuilt or placed on the market again.

CE marking may be relevant where:

• used machinery is imported from outside the EU and placed on the EU market for the first time,
• machinery has undergone substantial modification,
• machinery is rebuilt in a way that changes its safety functions or intended use,
• an assembly of machines creates a new machine or production line.

Each case should be assessed based on the machinery’s history, technical changes, intended use and applicable legal requirements.

CE marking for modified machinery

Modification of machinery may affect the validity of the original conformity assessment. If a modification changes the intended use, safety functions, performance, control system or risk profile, additional conformity assessment may be required.

Substantial modification may result in the modified machinery being treated as a new product for conformity assessment purposes.

Typical modifications requiring careful assessment include:

• changes to control systems,
• automation upgrades,
• integration of robots or AI-based functions,
• increase in speed, force or load capacity,
• changes to guarding or safety devices,
• new intended use,
• integration into a production line.

CE marking for production lines and assemblies of machinery

Production lines and assemblies of machinery may be treated as machinery where individual machines are arranged and controlled so that they function as an integrated whole.

In such cases, conformity assessment should address the complete assembly, including:

• interfaces between machines,
• shared control systems,
• emergency stop functions,
• safeguarding of transfer zones,
• access points and maintenance areas,
• combined risk assessment,
• instructions for the complete assembly.

The entity integrating the line may have manufacturer responsibilities for the complete assembly.

CE marking and harmonised standards for machinery

Harmonised standards support manufacturers in demonstrating conformity with essential health and safety requirements. When references to harmonised standards are published in the Official Journal of the European Union, correct application of those standards may provide presumption of conformity for the requirements they cover.

Machinery standards may include:

• Type A standards covering basic safety principles,
• Type B standards covering safety aspects or protective devices,
• Type C standards covering specific machine categories.

Application of harmonised standards is generally voluntary, but they are widely used as a practical method of demonstrating compliance.

CE marking and instructions for use

Instructions for use are an important part of machinery safety documentation. They must provide users with the information necessary for safe installation, operation, adjustment, maintenance and disposal where relevant.

Instructions may include:

• intended use of the machinery,
• reasonably foreseeable misuse,
• installation requirements,
• operating instructions,
• maintenance and inspection requirements,
• residual risks,
• personal protective equipment requirements,
• emergency procedures,
• transport and storage conditions.

Instructions must be consistent with the risk assessment and technical documentation.

CE marking and market surveillance

Machinery placed on the EU market may be subject to market surveillance by competent authorities. Authorities may request technical documentation, declarations of conformity, instructions and other evidence of compliance.

Market surveillance may result from:

• routine inspections,
• accidents or incidents,
• complaints,
• customs checks,
• non-compliance reports,
• sector-specific enforcement actions.

Incomplete documentation, incorrect CE marking or lack of conformity may lead to corrective measures, sales restrictions or product withdrawal.

Common CE marking mistakes for machinery

Common errors in machinery CE marking include incomplete assessment, incorrect documentation and misunderstanding of manufacturer responsibilities.

Typical issues include:

• incorrect identification of applicable legislation,
• incomplete risk assessment,
• failure to address all essential health and safety requirements,
• incorrect use of harmonised standards,
• missing or incomplete technical documentation,
• incorrect Declaration of Conformity,
• affixing CE marking before completing conformity assessment,
• lack of notified body involvement where required,
• incomplete instructions for use,
• failure to reassess modified machinery,
• incorrect classification of partly completed machinery.

Consequences of non-compliant machinery CE marking

Non-compliance with CE marking requirements may result in legal, commercial and operational consequences.

Possible consequences include:

• refusal of market access,
• customs detention,
• sales restrictions,
• withdrawal or recall of machinery,
• regulatory enforcement actions,
• contractual disputes,
• loss of customer trust,
• liability in case of accidents or injuries.

Maintaining complete conformity documentation is essential for demonstrating compliance during inspections, customer assessments and market surveillance activities.

CE marking and machinery safety

CE marking for machinery is closely linked to machinery safety. The process should demonstrate that hazards have been identified, risks have been reduced and users have received appropriate information on safe use.

Machinery safety may involve:

• inherently safe design,
• guards and protective devices,
• safety-related control systems,
• emergency stop functions,
• lockout and maintenance safety,
• safe access points,
• warnings and residual risk information,
• training and operating instructions.

Safety measures should be consistent with the risk assessment and the state of the art at the time of placing machinery on the market.

CE marking and cybersecurity for machinery

Modern machinery may include software, connectivity, remote access, data exchange, automation and AI-based functions. Where cybersecurity can affect safety, it may become relevant to conformity assessment.

Cybersecurity-related aspects may include:

• unauthorised access to safety-related control systems,
• remote manipulation of operating parameters,
• software integrity,
• data communication failures,
• security of updates,
• interaction between cybersecurity and functional safety.

The new Machinery Regulation strengthens attention to risks related to digital technologies, connected machinery and autonomous systems.

CE marking and artificial intelligence in machinery

Machinery using artificial intelligence, autonomous operation, self-learning functions or advanced software may require careful assessment of risks arising from system behaviour, data inputs and decision-making processes.

Relevant aspects may include:

• predictability of machine behaviour,
• human oversight,
• fail-safe functions,
• software validation,
• data integrity,
• interaction with safety-related systems,
• new risks introduced by autonomous operation.

Manufacturers should ensure that digital and AI-related functions are considered within the overall machinery risk assessment where they may influence safety.

CE marking and import of machinery into the EU

Machinery imported into the EU must comply with applicable EU requirements before being placed on the market. Importers have obligations to ensure that the manufacturer has carried out the required conformity assessment and that the required documentation is available.

Importers may need to verify that:

• the machinery bears CE marking where required,
• the EU Declaration of Conformity is available,
• instructions and safety information are provided,
• the manufacturer is identified,
• technical documentation can be made available to authorities,
• the product has not been modified in a way that affects conformity.

Imported used machinery may require additional assessment if it is placed on the EU market for the first time.

CE marking, manufacturer, importer and distributor responsibilities

Different economic operators may have different responsibilities under EU product legislation.

The manufacturer is responsible for designing, manufacturing and assessing the machinery before CE marking is affixed.

The importer may have obligations related to verification of conformity, documentation availability and product identification.

The distributor should act with due care and verify that obvious conformity elements, such as CE marking, instructions and required documents, are present where applicable.

An entity modifying machinery, integrating machinery into a production line or placing machinery on the market under its own name may assume manufacturer responsibilities.

How GCB supports machinery conformity assessment

GCB conducts conformity assessment activities for regulated product sectors, including machinery-related assessment within its notified scope.

GCB’s activities may include assessment of conformity documentation, evaluation of technical files, participation in conformity assessment procedures requiring notified body involvement, and certification activities carried out according to applicable legal requirements.

GCB operates in accordance with principles of independence and impartiality. This means that conformity assessment activities are separated from consultancy, design or implementation activities.

Why choose GCB for machinery CE marking-related assessment?

Organizations choose GCB because of its experience in regulated sectors, conformity assessment processes and technical documentation evaluation.

GCB offers:

• independent and impartial conformity assessment,
• experience in regulated product sectors,
• competence in technical documentation assessment,
• understanding of machinery safety requirements,
• assessment activities aligned with applicable EU requirements,
• support for organizations operating in European and international markets.

Contact GCB regarding CE marking and conformity assessment for machinery

If your organization is preparing machinery for the EU market, contact GCB to discuss the applicable conformity assessment route, technical documentation requirements and the possible need for notified body involvement.