The Machinery Directive becomes the Machinery Regulation – How can you prepare for the new obligations?

The European Union’s Machinery Directive will become the Machinery Regulation in January 2027, with no transitional period. The change affects all companies that use machinery, as well as machinery manufacturers, importers, and distributors. Sweco helps organizations of all kinds prepare for the new obligations in a practical and proactive manner.

What is the New Machinery Regulation?

The Machinery Regulation is the first piece of legislation in this area that is directly applicable in all EU Member States, meaning compliance with its requirements is mandatory. The objective of the Machinery Regulation remains the same as that of the Machinery Directive: to harmonize health and safety requirements for machinery across the EU and to support the free movement of machinery within the EU single market.

Although the requirements of the Machinery Regulation cannot be implemented differently at the national level, there may still be differences between Member States regarding the allocation of responsibilities and the penalties imposed for non-compliance or violations. For example, the consequences of incorrect CE marking may vary from one EU country to another.

Sweco provides up-to-date information on the requirements of the Machinery Regulation and helps organizations prepare well before the legislation enters into force.

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When will the Machinery Regulation enter into force?

The European Union’s Machinery Directive (2006/42/EC) will be replaced on 20 January 2027 by the Machinery Regulation (EU) 2023/1230, which, like the Directive, is binding on all Member States. No separate transition period will apply.

Which organizations are subject to the Machinery Regulation?

The requirements of the Machinery Regulation apply to all companies operating in Europe that use machinery. While the Regulation is primarily intended for machinery manufacturers, it also affects:

1. Industrial project owners and clients
2. Organizations responsible for machinery procurement
3. Machinery designers and engineers
4. Machinery importers
5. Machinery distributors and retailers

As a result, nearly all stakeholders throughout the industrial value chain need to understand their role in ensuring compliance with the Machinery Regulation. At Sweco, we can help you do exactly that.

Changes and new obligations under the Machinery Regulation

Most of the requirements of the Machinery Directive remain unchanged in the Machinery Regulation. If your organization is already well acquainted with the 2006 version of the Directive, only limited changes to your operations will be required. Key principles such as safe machinery design and conformity assessment remain largely the same.

The most significant changes and areas for development relate to cybersecurity, digital information exchange, software, and the consideration of artificial intelligence in risk assessments. Key changes include:

1. Cybersecurity is now explicitly included in the Machinery Regulation as a separate safety requirement. Otherwise, the Machinery Regulation has been separated from the EU AI Act. Sweco’s industrial cybersecurity experts can help you manage the broader information security and cybersecurity landscape.
2. Machinery safety measures must be documented in a way that clearly demonstrates which health or safety requirement each measure is intended to address.
3. The Machinery Regulation permits the use of digital technical documentation. However, manufacturers must also provide paper copies free of charge upon request.
4. The list of machinery subject to mandatory third-party conformity assessment is no longer fixed. Instead, it can be updated and expanded through a specific procedure established by the European Commission.
5. All software performing safety-related functions is considered a safety component of machinery. Such software requires its own technical documentation and either individual CE marking or type approval. This requirement also applies when the software is placed on the market as a standalone product.
6. The modernization or modification of machinery, whether physical or digital, may require updates to the machine’s technical file. In most cases, the impact will be on the risk assessment, which is considered a living document. The party modifying the machinery must be able to demonstrate whether the changes introduce new risks to people, property, or the environment. Read more about conformity assessment.
7. Even if machinery is built solely for internal use, the party constructing it is considered the manufacturer and must fulfill all obligations applicable to machinery manufacturers before the machinery is put into service.
8. Commercial operators placing machinery on the market are subject to requirements comparable to those imposed on manufacturers.
9. Distributors and importers must be prepared to provide information on machinery covered by the Machinery Regulation to local market surveillance authorities upon request.
10. Risk assessments for assemblies of machinery must consider the interfaces between the individual machines and components. Machinery must be designed and constructed so that connecting it to other equipment does not create hazardous situations.
11. The Regulation provides more precise definitions of machinery safety terminology, including concepts such as “machinery” and “substantial modification.” Machinery is now considered machinery even without software or control functions (previously referred to as “partly completed machinery” in certain contexts). One entirely new term introduced by the Regulation is “related product.”

Customer-focused services for ensuring Machinery Safety

Sweco has been providing machinery safety services for decades, giving us extensive expertise not only in machinery safety engineering but also in the legislation and regulatory requirements that govern machinery safety. In addition to delivering both large and small engineering and consulting projects, we actively participate in industry forums, working groups, and professional collaboration networks.

If you would like to better understand your organization’s current level of compliance with the Machinery Regulation, we always begin by assessing the actual need for change. Only then do we identify suitable options and recommend any necessary actions. In some cases, no changes may be required at all.

Our experts take a holistic approach to machinery safety. We integrate machinery safety requirements into the design, upgrade, and modernization of production lines and industrial facilities. When machinery safeguarding is implemented in a practical and proportionate manner, the result is a productive and efficient machine that also meets the requirements of the Machinery Regulation.

EU Declaration of conformity

The EU conformity assessment process remains unchanged under the Machinery Regulation. The EU Declaration of Conformity will continue to serve as formal confirmation that the applicable requirements of the Machinery Regulation have been met. Sweco supports machinery manufacturers in ensuring and demonstrating compliance throughout the machinery lifecycle.

We act as an independent party within the review process, enabling the manufacturer’s authorized representative to confidently sign the EU Declaration of Conformity and affix the CE marking to the machinery.

We can also assist with the preparation of technical files for machinery and assemblies of machinery, as well as the development of all required compliance and technical documentation.

Sweco’s Machinery Regulation experts

Sweco’s Machinery Regulation experts combine deep process and equipment expertise, modern analytical methods, and hands-on production experience. We help organizations optimize plant performance, improve quality, and reduce waste in a cost-effective and sustainable way.

Our expertise includes:

1. Machinery and process commissioning and fine-tuning
2. Production optimization and capacity improvement
3. Data utilization and analytics to support decision-making
4. Troubleshooting and root cause analysis
5. Continuous improvement methodologies
6. Complex production environments across a wide range of industries

We work closely with our clients to deliver measurable and sustainable improvements that create long-term value.

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Would you like to improve your production performance or solve a challenging machinery setup, Machinery Regulation, or optimization issue?

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