CE Marking – Machinery Directive
Full support to achieve CE marking for machinery in line with the Machinery Directive 2006/42/EC.
Our Support Includes
- Applicability assessment
- Risk assessment support
- Technical documentation
- CE Marking support
- Ongoing compliance advice
The Machinery Directive applies to:
Almost all machinery placed on the EU market, including related safety components, lifting accessories, chains, ropes and changeable equipment.
How the process works
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What we assess
Every CE marking project begins with a detailed review of the machinery and its intended use.
- Machinery type and function
- Intended operators and operating environment
- Safety-related control systems
- Existing documentation
- Design maturity
- Manufacturing arrangements
- Target markets
Applicable legislation may include
- Machinery Directive 2006/42/EC
- Machinery Regulation (EU) 2023/1230
- EMC Directive
- Low Voltage Directive
- Pressure Equipment Directive
- ATEX Directive
- Outdoor Noise Directive
- Other relevant product-specific regulations
The outcome is a clear compliance roadmap identifying all requirements necessary for CE marking.
Risk assessment scope
Using recognised methodologies such as ISO 12100, we systematically identify hazards and evaluate risks associated with the machinery.
- Mechanical hazards
- Electrical hazards
- Hydraulic and pneumatic hazards
- Ergonomic risks
- Noise and vibration exposure
- Thermal hazards
- Software and control system failures
- Maintenance-related risks
- Foreseeable misuse
Risk reduction
We then identify risk reduction measures and verify that appropriate safeguards have been implemented.
The completed risk assessment demonstrates compliance with the Essential Health and Safety Requirements (EHSRs) of the Machinery legislation.
Common machinery standards
Compliance with harmonised European standards provides a recognised route to demonstrating conformity.
- EN ISO 12100 - Risk Assessment and Risk Reduction
- EN 60204-1 - Electrical Equipment of Machines
- EN ISO 13849-1 - Safety-Related Control Systems
- EN ISO 14120 - Guards
- EN ISO 13857 - Safety Distances
- EN ISO 14119 - Interlocking Devices
Our review includes
- Standards applicability
- Current editions
- Compliance gaps
- Testing requirements
- Validation requirements
A standards compliance matrix is developed to demonstrate how the machinery meets applicable requirements.
Technical file evidence
European legislation requires manufacturers to maintain a technical file demonstrating compliance.
- Machine descriptions
- General arrangement drawings
- Electrical schematics
- Pneumatic and hydraulic diagrams
- Bills of materials
- Design calculations
- Risk assessments
- Standards compliance matrix
- Validation reports
- Test reports
- Safety control system documentation
- Software and PLC information
- Conformity assessment records
The technical file provides the evidence supporting CE marking and must be retained for regulatory purposes.
Instructions reviewed or developed
Instructions supplied with machinery are a critical compliance requirement.
- Operating instructions
- Installation instructions
- Maintenance procedures
- Troubleshooting guidance
- Emergency procedures
- Residual risk warnings
- Noise and vibration information
- Training requirements
- Decommissioning information
Product information reviewed
- Product labels
- Safety signage
- Warning notices
- Nameplate information
- Traceability markings
This ensures operators receive the information necessary to use the machinery safely.
Final compliance package
Once compliance has been demonstrated, we assist in completing the final CE marking process.
- Final compliance review
- Verification of technical documentation
- Confirmation of standards compliance
- Preparation of the EU Declaration of Conformity
- CE marking verification
- Product identification review
- Technical file completion
The Declaration of Conformity confirms that the machinery meets all applicable European legislation and provides the legal basis for CE marking.
Technical documentation review
Compliance does not end when CE marking is applied. Manufacturers must ensure machinery remains compliant as standards, regulations, software, components, and designs evolve.
- Technical file updates
- Engineering changes
- Design modifications
- Software revisions
- Safety improvements
Standards and documentation review
- New, withdrawn, and revised harmonised standards
- Changes affecting conformity
- Risk assessments
- Declarations of Conformity
- Manuals and instructions
- Product labelling
- Validation records
Compliance audit
- Technical file completeness
- Documentation control
- Standards compliance
- Product traceability
- Record retention
Annual manufacturer information
- New models, design changes, safety modifications, component substitutions, control system updates, and software changes
- Updated technical files, risk assessments, drawings, schematics, test reports, validation records, and user manuals
- Standards applied, new standards adopted, compliance assessments completed, and standards reviews undertaken
- Supplier declarations, CE certificates, test reports, and compliance statements
- Complaints, accidents, near misses, regulatory investigations, and product non-conformities
- Product modifications, field upgrades, corrective actions, safety notices, and product recalls
- Product models, serial numbers, batch information, manufacturing locations, and distribution chains
- Insurance confirmations and updated compliance contact details
Ongoing support
Machinery compliance is often affected by design changes, software updates, safety incidents, and regulatory inspections.
- Machinery modifications
- Significant design changes
- New product variants
- Software updates
- Regulatory inspections
- Market surveillance enquiries
- Customer complaints
- Incident investigations
- Product recalls
By engaging compliance support early, manufacturers can minimise regulatory risk and avoid costly corrective actions later.
Need Support with Machinery Compliance?
Get in touch with our team today.