When I deliver components that will be built into an installation or a unit, must these also be CE-marked?

Different components

• Incomplete machines: A combination of parts of machinery which can not in itself achieve a specific application also fall within the scope of the Machinery Directive 2006/42/EC. This means that incomplete machinery must be CE marked and must undergo the same conformity assessment procedure as complete machines. In these cases, the manufacturer of the complete installation or unit may need to issue a “Declaration of Incorporation” stating that the integrated components comply with relevant EU directives, regulations and standards when used as part of the system.

• Standalone Components: If the components you are delivering are standalone products with their own intended use and are subject to specific EU directives (e.g., machinery, electrical equipment, or pressure equipment), they should typically be CE marked on their own. The CE marking indicates that the components themselves comply with relevant EU regulations.

• Integral Parts of a Larger System: If the components are intended to be integrated into a larger installation or unit and do not have an independent use or function outside of that system, they may not need separate CE marking. In this case, the responsibility for CE marking and ensuring overall compliance may fall on the manufacturer of the complete installation or unit.

Responsibility of the manufacturer

The manufacturer of the complete installation or unit is responsible for ensuring that all integrated components, including those supplied by other manufacturers, meet the necessary regulatory requirements and safety standards. This may involve conducting risk assessments, compatibility assessments, and verification of compliance for the entire system. The manufacturer needs to ensure the Technical File of the complete installation is in accordance with the Machinery Directive. The documents in this file must give an insight to the design, manufacturing, risk assessment and operation of the machines.

Furthermore, is the traceability of components essential, and they should be clearly identified and documented, along with any necessary instructions for their correct and safe integration.

Conclusion

In summary, whether components need to be CE marked depends on their role and status in the context of the larger installation or unit. Incomplete machinery must be CE marked, Standalone components should typically have their own CE marking, while components that are integrated into a larger system may not require individual CE marking but should still comply with EU regulations. Coordination between component suppliers and manufacturers of complete systems is essential to ensure overall compliance and safety. Our experts are available to assist you in determining the necessary requirements for your components and can guide you through the process. Please feel free to contact us without hesitation.