EU Machinery Regulation What automation professionals need to know now

From Peter Goebbels* | Translated by AI 3 min Reading Time

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On January 20, 2027, the Machinery Regulation (2023/1230/EU) will come into force for companies in the EU. Businesses should already be familiarizing themselves with the new regulations.

With the new regulation, there are several points that automation professionals need to pay attention to.(Image: Omron)
With the new regulation, there are several points that automation professionals need to pay attention to.
(Image: Omron)

The transition from the Machinery Directive 2006/42/EC to Regulation 2023/1230/EU represents a significant change in the statutory requirements for machinery and related technologies. For system integrators, the regulation includes stricter requirements regarding the integration of AI-driven systems, autonomous machines, and connected devices. For end users, especially operators of complex machine systems, it is essential to prepare for the planned changes.

The overarching goal of the new regulation is similar to that of its predecessor version: ensuring safe design, reliable construction, and the safe use of machinery are at the forefront. However, the updated regulation aims to fill gaps in the original directive, particularly concerning advanced digital technologies and the complexity of modern manufacturing processes. Key innovations include a more structured approach to conformity assessments, specific provisions on digitalization and cybersecurity, and direct legal application in all EU member states without the need for national implementation.

One of the most notable structural changes is the alignment of the Machinery Regulation with the EU's New Legislative Framework (NLF). This approach simplifies compliance through harmonized procedures for various product categories. It also provides clarity on terminology and processes, especially for high-risk machinery and new risks associated with digital technologies such as AI and connected systems.

AI, cybersecurity, and digitalization

Perhaps the most transformative aspect of the new Machinery Regulation is its focus on digital technologies. It explicitly addresses risks related to AI, machine learning, and connected devices. Systems with partially or fully self-evolving behavior—as commonly found in AI-driven devices—now require more stringent third-party assessments. This is to ensure that adaptive, evolving systems remain safe even as they develop over time.

Cybersecurity is another important pillar of the regulation: machines must be designed to withstand criminal attacks aimed at damaging safety-critical components or software. This requirement aligns with the broader Cyber Resilience Act but is tailored to machine safety and considers the specific challenges in the manufacturing industry.

Digital documentation is a practical addition to the regulation, allowing manufacturers to provide user manuals and declarations of conformity online. This can reduce environmental impact and operating costs. At the same time, companies must also ensure that the digital resources remain accessible for at least ten years after a product's market introduction.

The staggered timeline of the Machinery Regulation provides companies working on industrial automation projects with a critical window for preparation. However, without a transition period, full compliance must be achieved by January 2027. To succeed, companies should first conduct a comprehensive review of existing machines and systems to identify gaps concerning the new requirements. Their main focus should be on provisions for high-risk machines, digital safety components, and cybersecurity vulnerabilities, as these areas are central to the updated regulation.

Early implemented and uniform standards and norms can also contribute to structured compliance, if available, even though many standards are still being revised. Training is another important step to properly equip and prepare teams and employees with the know-how required for the application of new technologies.

For system integrators and end users, the new Machinery Regulation provides a solid framework for driving innovation and ensuring safety in an increasingly digital manufacturing landscape. Companies and their decision-makers should act now to achieve a seamless transition. By doing so, they can optimally leverage potential opportunities and create resilient systems that meet future requirements. (kip)

*Peter Goebbels is Product Specialist Safety at Omron Industrial Automation

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