Machinery Directive Guide

The Machinery Directive 2006/42/EC is a set of EU health and safety requirements that apply to new and modified machinery used in the workplace. 

Their purpose is to prevent machinery and equipment from causing harm or damage to users and their environments. 

It’s also one of several directives that are covered by the CE marking regulations. If applicable, demonstrating compliance with the Machinery Directive is a mandatory part of the CE marking process for most products, equipment, and machinery sold within the European Economic Area (EEA).

This guide explains what the Machinery Directive covers, who it applies to, what testing and documentation are required, and how to demonstrate full compliance to support CE marking.

You can download the full version of the Machinery Directive here.

What is the Machinery Directive, and which equipment does it apply to?

The Machinery Directive applies to new and significantly modified machinery to ensure that it does not present risks to health, safety, or the environment.

The regulations define “Machinery” as:

• An assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application.
• An assembly missing only the components to connect it on site or to sources of energy and motion.
• An assembly ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure.
• Assemblies of machinery or partly completed machinery which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole.
• An assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort.

Thus, products missing only the electric motor, requiring mounting (e.g. a hydraulic lifting arm) onto a vehicle or structure/building), or to be assembled with others, are all regarded as machinery in the strict sense.

Other items covered by the regulations include:

• Interchangeable equipment (machinery which has previously been used for another purpose)
• Safety components (necessary for the safety of the machine)
• Lifting accessories (placed between machinery and a load)
• Chains, ropes and webbing
• Removable mechanical transmission devices (such as components used to transmit power between two machines)

Who’s responsible for compliance?

Machinery Directive applies to:

• Manufacturers, including those producing machinery for in-house use
• Parties modifying existing machinery such that it qualifies as “new” machinery
• Importers bringing non-CE-marked machinery into the EEA for the first time

Key responsibilities under the directive include:

• Ensure safety: Machinery must not pose risks when properly installed and maintained.
• Satisfy EHSRs: Compliance with all applicable essential health and safety requirements is mandatory.
• Compile technical documentation: A complete technical file must be created and made available on request.
• Provide operational information: Clear instructions for safe installation, operation, and maintenance must accompany the machinery.
• Carry out conformity assessment: This includes procedures such as internal checks, type examinations, or quality assurance systems depending on machinery classification.
• Declaration of Conformity: A signed EU Declaration of Conformity (DoC) must accompany CE-marked machinery; for UKCA-marked machinery, a UK DoC is required.
• Affix the CE marking: The CE mark must be clearly and visibly attached to compliant equipment.
• For partly completed machinery: Prepare assembly instructions and a Declaration of Incorporation, both of which must accompany the machine until it becomes part of a fully compliant unit.

Who enforces the Machinery Directive, and what are the penalties for non-compliance?

In Great Britain, the Health and Safety Executive (HSE) enforces regulations set out by the Machinery Directive.

Non-compliance with the Machinery Directive is an offence that can lead to a fine, imprisonment of up to two years, or both. In most cases, HSE will immediately recall non-compliant equipment and products.

How do you carry out testing against the Machinery Directive?

For organisations performing conformity assessments, two routes are permitted by the Machinery Directive.

1. Self-certification: A manufacturer may perform and document the conformity assessment themselves.
2. Involvement of a notified body: A manufacturer may employ the services of a third-party certification body, known as the ‘Notified Body’.

The Machinery Directive specifies a list of 23 machines for which it is mandatory to involve a Notified Body in the conformity assessment:

1. Circular saws and sawing machinery.
2. Hand-fed surface planing machinery for woodworking.
3. Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.
4. Band-saws with manual loading and/or unloading for working with wood and material.
5. Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material.
6. Hand-fed tenoning machinery with several tool holders for woodworking.
7. Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.
8. Portable chainsaws for woodworking.
9. Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
10. Injection or compression plastics-moulding machinery with manual loading or unloading.
11. Injection or compression rubber-moulding machinery with manual loading or unloading.
12. Machinery for underground working of the following types such as locomotives, brake-vans and hydraulic-powered roof supports.
13. Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.
14. Removable mechanical transmission devices including their guards.
15. Guards for removable mechanical transmission devices.
16. Vehicle servicing lifts.
17. Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three metres.
18. Portable cartridge-operated fixing and other impact machinery.
19. Protective devices designed to detect the presence of persons.
20. Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11.
21. Logic units to ensure safety functions.
22. Roll-over protective structures.
23. Falling-object protective structures.

For a detailed version of the Annex IV list, see page 45 of the full Machinery Directive downloadable above.

If you’re able to and would like to self-certify, it involves a comprehensive analysis of all identifiable risks. 

Using the harmonised standards that apply to your machinery, create or use an audit checklist to evaluate your machine’s design and function. Go through each requirement line by line, recording whether the machinery meets, partially meets, or fails to meet the criteria. 

For every hazard found, carry out a structured risk assessment:

• Clearly describe the nature of the hazard
• Assign a risk grade based on established criteria (e.g., using a risk matrix)
• Evaluate whether risk reduction measures (e.g., guards, control systems, training) are effective
• Determine if additional controls are needed

Using the checklist and risk assessments, prepare a technical report. This report should:

• Summarise the compliance status of the machine
• Highlight non-conformities
• Outline any remedial actions required

What documentation do you need?

Under the Machinery Directive, you are required to establish technical documentation that demonstrates conformity equipment with the Directive's essential requirements. 

This documentation must be sufficiently detailed to allow for the assessment of the product's compliance and should encompass all relevant aspects of design, manufacture, and operation.

The technical documentation should include:

• A general description of the equipment
• Design and manufacturing drawings, along with schemes of components, sub-assemblies, and circuits
• Explanations necessary for understanding the drawings and the operation of the equipment
• Risk assessments carried out
• A list of harmonised standards applied, including essential health and safety requirements covered
• Results of design calculations, examinations carried out, etc
• Declaration of conformity
• Declaration of incorporation (for partly completed machinery)

The manufacturer must keep this documentation for 10 years after the equipment is placed on the market and should make it available to the competent national authorities upon request.

How does the Machinery Directive fit into CE marking regulations?

Many machines fall under more than one EU directive. And the Machine Directive doesn’t cover all safety or performance aspects of a product.

For example, equipment may also fall under the Low Voltage Directive or the EMC Directive, as well as Machinery Directive.

In these cases, the manufacturer must:

• Identify all applicable directives based on the product type, intended use, and environment
• Ensure the product meets the essential requirements of each directive, which may include safety, energy efficiency, or hazardous substance restrictions
• Compile a single technical file that covers the conformity assessment evidence for all applicable directives
• Draft a single Declaration of Conformity (DoC) that references each relevant directive and harmonised standard
• Affix the CE mark, which symbolises compliance with all relevant EU legislation, not just one

Note that, the CE mark does not indicate conformity with a single directive. It represents compliance with all EU legislation applicable to the product.

Download our free guide here for more information on complying with CE regulations.

Comply with the Machine Directive with total confidence

Our start-to-finish Machinery Safety Testing service for large and medium-sized capital equipment covers every step of the process, from testing against relevant measures to compiling your technical documentation and addressing remedial actions.

Head to our Machinery Safety Testing service page here to find out more.