CE marking for machinery: a complete guide

If you manufacture any product with powered moving parts — motors, actuators, conveyors, pumps, robots — the Machinery Directive 2006/42/EC almost certainly applies. This guide explains what it requires, how to achieve compliance, and what changes are coming.

What is the Machinery Directive?

The Machinery Directive (2006/42/EC) is the main EU regulation governing the safety of machinery placed on the EU market. It sets essential health and safety requirements (EHSRs) that all in-scope machinery must meet, covering everything from guard design to noise declarations.

The UK equivalent — the Supply of Machinery (Safety) Regulations 2008 (SI 2008/1597) — applies for the GB market and requires UKCA marking instead of CE.

Does it apply to my product?

The directive covers machinery, defined as an assembly with at least one moving part driven by a power source other than direct human or animal effort. In practice, if your product has a motor, actuator, or any powered mechanism, it is likely in scope.

Common in-scope products include:

• Industrial robots and automation equipment
• Conveyors, lifts, and hoists
• Power tools (drills, grinders, saws)
• Pumps and compressors
• Food processing equipment
• 3D printers and CNC machines
• Garden machinery (mowers, chippers)

Out of scope: purely electrical products with no mechanical hazard (covered by LVD), medical devices, weapons, and vehicles. Simple hand tools powered only by muscle are also excluded.

Standard vs Annex IV machinery

Most machinery can self-certify: the manufacturer conducts a risk assessment, applies harmonised standards, builds a Technical File, signs a Declaration of Conformity, and affixes the CE mark. This is the self-declaration route (Annex VIII).

However, a list of high-risk categories in Annex IV requires involvement of a Notified Body. These include:

• Circular and band saws for woodworking
• Presses for working cold metal
• Injection and compression moulding machines
• Underground mining machinery
• Portable chain saws
• Guards and safety components sold separately
• Valves with integrated safety functions

If your product falls into Annex IV, you must use one of three routes: EC type-examination (Annex IX), full quality assurance (Annex X), or design/manufacture quality assurance (Annex IX).

The conformity assessment process

1. Risk assessment — identify all hazards using EN ISO 12100. Document every hazard, its severity, probability, and the risk-reduction measures applied.
2. Apply harmonised standards — standards like EN 60204-1 (electrical equipment), EN ISO 13849-1 (safety-related control systems), and product-specific type-C standards give presumption of conformity with the EHSRs.
3. Build the Technical File — drawings, calculations, test reports, risk assessment, instructions, and the Declaration of Conformity. Retain for 10 years.
4. Sign the Declaration of Conformity — lists the applicable directives and harmonised standards. Keep a copy; attach one to the product or pack.
5. Affix CE mark — minimum 5mm height; on the product and, where appropriate, packaging.
6. Provide instructions for use — in the language(s) of the country of use. Must include noise and vibration declarations (Annex I §1.7.4).

Key harmonised standards

UKCA marking for machinery

For the Great Britain market (England, Wales, Scotland), you need UKCA marking under the Supply of Machinery (Safety) Regulations 2008. The technical requirements are essentially the same as the EU Directive (retained EU law), so the same risk assessment and Technical File serves both marks. However:

• You must sign a separate UK Declaration of Conformity referencing the UK SI.
• For Annex IV equivalents, you need a UK Approved Body, not an EU Notified Body.
• Northern Ireland still requires CE marking under the Windsor Framework.
• CE marking is no longer accepted as an alternative to UKCA in GB for most categories (transition periods expired January 2025).

Common mistakes

• Missing Annex IV — not checking whether your specific product category needs a Notified Body. Check the Annex IV list carefully.
• Incomplete risk assessment — listing hazards without documenting the risk reduction measures and residual risk is not compliant.
• No noise/vibration declaration — legally required in Instructions for Use (Annex I §1.7.4).
• Sub-assemblies with CE marks — partly completed machinery must NOT carry a CE mark. Use a Declaration of Incorporation instead.
• Ignoring the 2027 transition — Regulation (EU) 2023/1230 has new requirements for connected/AI machinery. Start assessing impact now.