Industrial Robot CE Marking

Last updated: 2026-02-16

To achieve CE marking for industrial robots, manufacturers must comply with the relevant European Union regulations and harmonized standards, primarily the Machinery Directive 2006/42/EC. This involves conducting risk assessments, preparing comprehensive documentation, and, in some cases, engaging notified bodies for conformity assessment.

Summary

CE marking indicates that a product meets specific safety and health requirements in the European market. For industrial robots, compliance involves several steps, including risk assessment following ISO 12100, adherence to harmonized standards like EN ISO 10218, and the preparation of a technical file documenting safety measures and test results. Understanding the roles and responsibilities of all parties involved—manufacturers, integrators, and end-users—is crucial for successful compliance.

What are the specific CE marking requirements for industrial robots under EU regulations?

The primary regulation for CE marking in the context of industrial robots is the Machinery Directive 2006/42/EC, which is transitioning to Regulation 2023/1230 by January 20, 2027. This regulation sets out essential health and safety requirements that must be met before a robot can be marketed in the EU. Key requirements include ensuring that the robot is designed and constructed to operate safely, minimizing risks to users and other personnel.

Manufacturers must ensure that their products conform to the essential requirements of the directive. This involves demonstrating compliance through a technical file, which includes various documents such as design and manufacturing plans, risk assessments, and evidence of compliance with harmonized standards.

Which harmonized standards must be applied to achieve CE compliance for industrial robots?

For industrial robots, the relevant harmonized standards are primarily EN ISO 10218-1 and EN ISO 10218-2. Compliance with these standards is necessary to presuppose conformity with the essential health and safety requirements outlined in the Machinery Directive.

EN ISO 10218-1 focuses on safety requirements related to the design and construction of robots, while EN ISO 10218-2 addresses safety requirements for the integration of robots into systems. Manufacturers should familiarize themselves with these standards to ensure their robots are designed with safety in mind.

What are the responsibilities of manufacturers, integrators, and end-users in the CE marking process?

Each party involved in the CE marking process has specific responsibilities:

• Manufacturers are responsible for ensuring their robots meet all applicable safety standards and regulations. They must conduct risk assessments, compile technical documentation, and affix the CE mark.

• Integrators must ensure that the systems they create that incorporate these robots are compliant with safety requirements. This includes assessing any additional risks introduced by the integration process and ensuring that all components work safely together.

• End-users are responsible for operating the robots in a manner consistent with the manufacturer’s instructions and safety guidelines. They must also maintain the robots to ensure ongoing compliance with safety standards.

Understanding these roles is critical to achieving compliance and maintaining safety in robotic applications.

How should risk assessments be conducted in line with ISO 12100:2010 for industrial robots?

Risk assessment is a fundamental part of the CE marking process, particularly for industrial robots. Following ISO 12100:2010, manufacturers should follow a structured approach to identify hazards, assess risks, and implement necessary risk reduction measures.

1. Hazard Identification: Identify potential hazards associated with the robot's operation, including mechanical, electrical, and operational risks.

2. Risk Assessment: Evaluate the likelihood and severity of each identified hazard, determining the overall risk level.

3. Risk Reduction: Implement measures to reduce risks to acceptable levels. This can include redesigning components, adding safety features, or providing proper training for operators.

4. Documentation: Maintain records of the risk assessment process and the measures taken, as this documentation will be essential for the technical file.

A thorough risk assessment not only helps achieve CE marking but also enhances the overall safety of robotic operations.

What documentation is necessary to support CE marking, and how should it be compiled?

Compiling the necessary documentation is a crucial step in the CE marking process. The technical file should include:

• Design and Manufacturing Plans: Detailed descriptions of the robot's design, components, and manufacturing processes.
• Risk Assessment Reports: Documentation of the risk assessment process and the measures implemented.
• Test Results: Evidence from any testing conducted to demonstrate compliance with relevant standards.
• User Instructions: Clear operating instructions and safety guidelines for end-users.

This documentation must be organized and readily available for review by notified bodies or relevant authorities if required. Maintaining thorough and accurate records can streamline the compliance process and help avoid delays.

When is the involvement of a notified body required in the CE marking process for industrial robots?

Involvement of a notified body is required for certain types of machinery specified in Annex IV of the Machinery Directive. This includes robots that fall under specific categories deemed to have higher safety risks.

If the robot is classified under these categories, manufacturers must work with a notified body to conduct a conformity assessment. The notified body will evaluate the design and performance of the robot to ensure compliance with EU regulations.

Even if a notified body is not required, manufacturers may still choose to involve one to gain an additional layer of assurance regarding compliance.

What are the steps to affix the CE marking and prepare the EU Declaration of Conformity?

Once all compliance steps are completed, manufacturers can affix the CE mark to their robots. The steps to do so include:

1. Prepare the EU Declaration of Conformity: This document states that the product meets all applicable safety requirements and includes information about the manufacturer, the robot, and the relevant standards.

2. Affix the CE Mark: The CE marking should be clearly visible on the robot, allowing for easy identification of compliance.

3. Maintain Records: Keep a copy of the EU Declaration of Conformity and all documentation related to the CE marking process for at least ten years after the product has been placed on the market.

By following these steps, manufacturers can ensure their robots are compliant and safe for use within the European market.

What we recommend

For manufacturers navigating the complexities of CE marking for industrial robots, investing in a structured approach to compliance management is crucial. Tools that facilitate documentation, risk assessment, and regulatory tracking can greatly enhance the efficiency of this process. EmetGrid offers practical solutions that help teams identify compliance gaps and prepare for certification, making it a sensible choice for those seeking to streamline compliance operations in the robotics field.