The Machinery Directive (2006/42/EC) is a central piece of European Union legislation that ensures the safety of machinery placed on the EU market. It sets out essential requirements for the design, manufacture, and conformity assessment of machinery and partly completed machinery to promote the free movement of goods while ensuring a high level of protection for users and the environment.
What is the Machinery Directive?
The Machinery Directive applies to machinery and assemblies of machinery that are powered and have moving parts, including industrial robots, packaging machines, construction equipment, and woodworking machines. It also applies to safety components and partly completed machinery (which cannot function independently).
It has been applicable since 29 December 2009, replacing the previous Directive 98/37/EC. A new regulation—the Machinery Regulation (EU) 2023/1230—will fully replace this directive starting 20 January 2027, but until then, 2006/42/EC remains in force.
Scope of the Machinery Directive
The directive applies to:
- Industrial machinery and production equipment
- Agricultural and forestry machinery
- Lifting equipment (e.g. cranes, lifts)
- Safety components (e.g. light curtains, interlocks)
- Partly completed machinery (e.g. sub-assemblies meant for incorporation)
It does not apply to:
- Household appliances (covered by the LVD)
- Military equipment
- Means of transport (cars, aircraft, ships)
- Medical devices
- Electrical and electronic consumer products without moving parts
Essential Health and Safety Requirements (EHSRs)
Annex I of the Machinery Directive outlines the Essential Health and Safety Requirements (EHSRs) that must be considered during design and manufacturing. These include:
- Safety against mechanical, electrical, thermal, and other risks
- Ergonomic design
- Protection against moving parts and entrapment
- Emergency stop and safe control systems
- Safe assembly, maintenance, and decommissioning procedures
- Risk reduction through inherently safe design, safeguarding, and user information
Manufacturers must carry out a comprehensive risk assessment and integrate protective measures throughout the machine’s lifecycle.
Conformity Assessment and CE Marking
Before a machine is placed on the market, the manufacturer must:
- Ensure the machine meets all relevant EHSRs
- Apply harmonised standards where available
- Conduct or coordinate the appropriate conformity assessment procedure
- Compile a technical file with design, test, and safety information
- Issue an EU Declaration of Conformity
- Affix the CE marking and ensure correct documentation accompanies the product
In some cases (e.g. high-risk machinery listed in Annex IV), involvement of a Notified Body is required.
Harmonised Standards and Presumption of Conformity
Using relevant harmonised EN standards under the Machinery Directive provides a presumption of conformity. Common standards include:
- EN ISO 12100: Risk assessment and risk reduction
- EN ISO 13849-1: Safety-related control systems
- EN 60204-1: Electrical equipment of machines
These standards help ensure consistency, reliability, and legal certainty in design and assessment.
Responsibilities of Economic Operators
- Manufacturers: Responsible for ensuring compliance, preparing the technical file, and issuing the Declaration of Conformity.
- Importers and Distributors: Must verify that machinery meets EU requirements, has CE marking, and includes the necessary instructions and documentation.
Looking Ahead: Machinery Regulation (EU) 2023/1230
The Machinery Directive will be replaced by the Machinery Regulation starting 20 January 2027, which will include updates related to digital documentation, cybersecurity, and artificial intelligence in machinery. Early awareness and planning for this transition are strongly recommended.
Contact Us
Compliance with the Machinery Directive is essential not only for legal market access in Europe but also for protecting users and avoiding costly liabilities. Whether you're designing new machinery, assembling partly completed components, or preparing for the upcoming regulation, we are here to help.
Contact us today for expert support with risk assessment, CE marking, technical file preparation, and ensuring full compliance with the Machinery Directive and upcoming EU machinery regulations.
