The Machinery Regulation (EU) 2023/1230 will replace the Machinery Directive 2006/42/EC from 2027 with the aim of increasing the safety of machinery and partly completed machinery, improving regulatory clarity in line with technological progress. Find out what specific obligations apply to manufacturers of partly completed machinery.

Reading Time: 4 minutes Difficulty: Advanced
11 July 2024
11 July 2024
Reading Time: 4 minutes Difficulty: Advanced

The Machinery Regulation (EU) 2023/1230 will replace the Machinery Directive 2006/42/EC from 2027 with the aim of increasing the safety of machinery and partly completed machinery, improving regulatory clarity in line with technological progress. Find out what specific obligations apply to manufacturers of partly completed machinery.

Definition of partly completed machinery

The Machinery Regulation (EU) 2023/1230 specifies that a “partly completed machine” is:
an assembly that constitutes part of a machine but which alone cannot guarantee a specific function.

Partly completed machinery is intended to be incorporated into or assembled with other machinery or other partly completed machinery, thereby forming a machine.

Responsibility of the manufacturer

The main obligations of the manufacturer of partly completed machinery in relation to the new European regulation are the following:

1. Compliance with essential health and safety requirements

The manufacturer must ensure that the partly completed machinery is designed and constructed in compliance with the relevant essential health and safety requirements, as specified in the regulation. This involves a thorough risk assessment and the implementation of appropriate mitigation measures.

2. Technical documentation

The manufacturer is required to draw up detailed technical documentation demonstrating the conformity of the partly completed machinery with the applicable requirements. This documentation must be made available to the competent authorities and retained for a period of at least ten years from the date of manufacture of the last partly completed machine.

3. Assembly instructions

Detailed instructions on assembly must be provided with the partly completed machinery on how to safely integrate the latter in the final machinery. These instructions must include all safety measures to be taken during the process of assembly and installation.

4. Declaration of incorporation

The manufacturer must provide a declaration of incorporation for each partly completed machine, certifying that it complies with the applicable requirements of the regulation and indicating the directives with which it complies. The declaration must also specify that the partly completed machine must not be put into service until the complete machine, in which it will be incorporated, has been declared to comply with the requirements of the regulation.

5. Risk assessment

The manufacturer must carry out an assessment of the risks associated with the partly completed machine and document the results of this assessment. The risk assessment must be included in the technical documentation.

6. CE marking

The partly completed machinery must not be CE marked. However, it must be accompanied by the declaration of incorporation and the assembly instructions necessary to ensure conformity when integrated into the final machine.

7. Cooperation with the authorities

The manufacturer must cooperate with the national market surveillance authorities and provide all the information and documentation necessary to demonstrate the conformity of the partly completed machinery. In the event of non-compliance, the manufacturer must take all necessary corrective measures to make the partly completed machine compliant or to withdraw it from the market.

8. Updating the documentation

The manufacturer must keep the technical documentation up-to-date, reflecting any changes or improvements made to the partly completed machinery. This is essential to ensure that the partly completed machinery produced complies with the applicable essential health and safety requirements.

Practical implications

The new European regulation aims to improve the safety of machines and partly completed machinery on the market, increasing the responsibility of manufacturers and ensuring that only safe machines can circulate and be put into service within the Union.
Legislative obligations imply that manufacturers of partly completed machinery must adopt a rigorous approach in the design, documentation and verification of the safety of their products.
They must also ensure transparent and complete communication with customers and market surveillance authorities. Non-compliance may result in penalties, withdrawal of the partly completed machinery from the market and, with it, damage to the manufacturer’s reputation.

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