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The Machinery Regulation (EU) 2023/1230 is the new European regulation replacing the Machinery Directive 2006/42/EC. It was published on 29 June 2023 and entered into force on 19 July 2023. From 20 January 2027, it will become fully applicable and directly binding across all EU states.

This regulation aims to ensure that machinery placed on the market or put into service meets high safety and health protection standards. These standards have been updated to now also cover digitalization, cybersecurity, and modern technologies. While the regulation applies primarily in the EU, many manufacturers outside Europe refer to it as a useful comprehensive safety framework.

This updated guide gives an overview of the key definitions, requirements, and documentation needed for compliance under the new regulation.

 

Key Definitions

  • Machinery: Assemblies with at least one moving part, powered by energy sources beyond direct human or animal effort.

  • Interchangeable equipment: Add-ons that modify the function of machinery.

  • Safety components: Devices essential to safety, which can pose risks if they fail.

  • Lifting accessories: Equipment like slings or forks placed between machinery and a load.

  • Chains, ropes, and webbing: Designed for lifting as part of lifting machinery.

  • Removable mechanical transmission devices: Transmit power between machinery.

  • Partly completed machinery: Incomplete assemblies meant to be integrated into complete machines.

What the Regulation Does Not Cover

Examples of exclusions include:

  • Safety components used as spare parts

  • Military or police equipment

  • Machinery on seagoing vessels or offshore units

  • Household appliances, IT equipment, audio/video devices, etc., covered by other directives

hooksLifting accessories are also covered in the EU Machinery Regulation.


Key Requirements

Annex III – Essential Health and Safety Requirements

  • Mandatory risk assessments to identify and mitigate potential hazards throughout the entire lifecycle of the machinery

  • Design and construction must prioritize user safety during operation, maintenance, and disposal

  • Information must be provided on any residual risks and necessary protective measures

Technical Documentation

  • The technical file must demonstrate compliance and include detailed drawings, test results, certificates, and risk assessment documentation

Marking (Article 22 & Annex IV)

Machinery must be clearly and durably marked with:


  • Manufacturer’s name and address
  • Type and serial number
  • CE marking
  • Year of construction

Instructions for Use (Annex IV)

A comprehensive user manual must accompany the machinery, covering:


  • Technical specifications
  • Safe usage instructions
  • Maintenance and repair guidance
  • Residual risks and protective measures

Certificates for Lifting Equipment (Annex IV)

Lifting components such as chains and ropes must include certificates stating:


  • Maximum load
  • Technical description and testing method
  • Manufacturer details

Conformity Assessment (Articles 25–36)

  • Machinery is classified by risk level. High-risk machinery (listed in Annex I) requires third-party (notified body) certification unless manufactured in full compliance with harmonized standards


Declaration of Conformity (Annex V)

The manufacturer must draw up and sign a Declaration of Conformity, listing:


  • Identity of manufacturer and authorized person
  • Machinery details and applicable regulations
  • Harmonized standards used
  • Signature and date

kran4A crane is an example of machinery covered int he EU Machine Regulation.

 

Digital documents 

The new Machinery Regulation opens up the possibility for technical, compliance and safety documentation to be provided digitally. This is a departure from the previous Machinery Directive which mandated the provision of paper documentation. The transition to digital signals a modernization of legislation to keep up with the digital shift for better control over machinery and more sustainable supply processes. 

 

Transition Period

Between now and 20 January 2027, manufacturers may continue complying with Directive 2006/42/EC. After 20 January 2027, compliance with Regulation (EU) 2023/1230 becomes mandatory.

 

Conclusion

The new EU Machinery Regulation provides a modernized, harmonized framework for machinery safety in Europe. While much of the structure and many principles remain familiar, new emphasis is placed on digital elements, documentation, and cybersecurity.

Using a cloud-based software solution such as Onix Work helps manufacturers and equipment owners manage documentation, risk assessments, and conformity declarations effectively. By digitizing this process, companies can more easily stay compliant and ensure safety throughout the product lifecycle. 

 

For further details, consult the full regulation text here: EU Machinery Regulation (2023/1230)

 

If you have questions or need help aligning your documentation processes, feel free to reach out!

 

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