Industrial robots and cobots

• Regulation (EU) 2023/1230 — Machinery
• Directive 2014/30/EU — EMC
• Regulation (EU) 2024/1689 — AI Act where safety functions use AI
• Regulation (EU) 2024/2847 — CRA for connected controllers

Who has to appoint one

Manufacturers outside the Union placing robots, cells or autonomous mobile robots on the EU market. A robot arm supplied alone is partly completed machinery; the integrator assembling the cell becomes the manufacturer of the assembly with its own conformity obligation.

Thresholds and exemptions

None. The new Machinery Regulation lists safety components with self-evolving behaviour among the high-risk products requiring third-party involvement, which affects AI-based safety functions.

What must appear on the label

CE marking, manufacturer and EU representative details, designation, serial number and year of construction, and for the assembled cell the integrator's own marking. Partly completed machinery carries a declaration of incorporation instead.

Marketplace fields

Industrial buyers require the declaration of conformity for the cell as installed, not only for the robot, and insurers ask for the risk assessment after any incident.

Documentation you must hold

EU declaration of conformity, technical file with the risk assessment covering the whole cell, safety-related control system documentation with performance levels, and for partly completed machinery the declaration of incorporation with assembly instructions.

Standards and testing

EN ISO 10218-1 and -2 for industrial robots and robot systems, ISO/TS 15066 for collaborative operation including force and pressure limits, EN ISO 13849-1 for safety-related control systems, and EMC testing.

Language requirements

Instructions and safety information in the language of the member state where the machine is put into service, including the residual risks and the safeguarding assumptions.

When it applies

Before placing on the market or putting into service. Machinery Regulation 2023/1230 applies from 20 January 2027 and introduces the high-risk categories.

How long records are kept

Ten years for technical documentation, and the integrator's cell documentation for the same period.

What happens if you do not comply

Prohibition of use, withdrawal, and criminal liability where an operator is injured. Collaborative applications that exceed the force and pressure limits are the recurring finding.

Who enforces it

Market surveillance authorities, labour inspectorates and notified bodies for the high-risk categories.

Where the boundary lies

A collaborative robot is not inherently safe: safety depends on the application, and the force and pressure limits must be validated for the specific task with the specific tooling. The integrator carries that obligation, not the robot maker.

Questions we are asked

Is a cobot exempt from guarding?

No. Collaborative operation must be validated against the force and pressure limits for the actual application, including the tool and workpiece.

Who declares conformity for a robot cell?

The integrator that assembles it, as manufacturer of the assembly, using the component declarations as inputs.