Regulation & compliance
Directive 2006/42/EC
The EU legal basis for CE marking machinery until 20 January 2027, when Regulation (EU) 2023/1230 replaces it.
Machinery Directive 2006/42/EC
- Category
- Regulation & compliance
- Scope
- EU
- Edition / refs
- Directive 2006/42/EC — repealed from 20 January 2027
MSA output
- Risk assessment (EN ISO 12100)
- CE Technical File
- PLr / SIL calculations & validation protocols
- Sign-off documentation
What is Directive 2006/42/EC?
Directive 2006/42/EC sets the essential health and safety requirements (EHSRs) that machinery must meet before it can be placed on the EU market and CE marked. It covers machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices and partly completed machinery.
The Directive is repealed by the EU Machinery Regulation (EU) 2023/1230 with effect from 20 January 2027. Until then it remains the basis for CE marking machinery in the EU. In Great Britain, the equivalent supply legislation is the Supply of Machinery (Safety) Regulations 2008.
Who it applies to
- Manufacturers of machinery placed on the EU market
- System integrators who create assemblies of machinery
- Suppliers of partly completed machinery
- Authorised representatives acting for manufacturers outside the EU
Key requirements
- 01
Risk assessment and EHSRs (Annex I)
Carry out a risk assessment to determine the applicable EHSRs, then design and build the machine taking its results into account.
- 02
Technical file (Annex VII A)
Compile the technical documentation and keep it available for at least 10 years after manufacture of the machine or the last unit of a series.
- 03
Conformity assessment (Article 12)
Internal checks (Annex VIII) for most machinery. Annex IV categories need EC type-examination (Annex IX) or full quality assurance (Annex X), unless harmonised standards covering all relevant EHSRs are fully applied.
- 04
Instructions
Supply instructions in the official language(s) of the member state where the machine is placed on the market or put into service.
- 05
EC Declaration of Conformity and CE marking
Draw up and sign the Declaration of Conformity (Annex II 1.A) and affix the CE marking (Annex III).
- 06
Partly completed machinery
Relevant technical documentation (Annex VII B), assembly instructions (Annex VI) and a Declaration of Incorporation (Annex II 1.B) — no CE marking under the Directive.
Summary for orientation only. Always refer to the current official text of Directive 2006/42/EC and any applicable legislation.
MSA for Directive 2006/42/EC
What MSA generates
Evidence produced from your engineering inputs, traceable end to end and exported to Word, PDF or Excel.
Risk assessment (EN ISO 12100)
The Annex I risk assessment, structured to the harmonised method.
CE Technical File
Technical documentation assembled from your engineering inputs, with traceability throughout.
PLr / SIL calculations & validation protocols
Control system requirements and validation evidence for each safety function.
Sign-off documentation
Approval records ready for the Declaration of Conformity.
Frequently asked questions
When does the Machinery Directive stop applying?
It is repealed from 20 January 2027, the date from which Regulation (EU) 2023/1230 applies. Machinery placed on the EU market from that date must comply with the Regulation.
Does an integrator have to CE mark a production line?
When machines are arranged and controlled to function as an integrated whole, they form an assembly of machinery. The person who creates the assembly is its manufacturer and must carry out the conformity assessment, compile the Technical File and CE mark the assembly. The Commission’s Guide to application of the Machinery Directive explains how this applies.
What is partly completed machinery?
An assembly that is almost machinery but cannot by itself perform a specific application — the Directive gives a drive system as an example. It is supplied with a Declaration of Incorporation and assembly instructions, and is covered by the CE marking of the final machine.
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