The EU Machinery Regulation replaces the EU Machinery Directive and requires manufacturers to integrate cybersecurity and software safety, perform more detailed risk assessments, and account for new technologies like artificial intelligence (AI) and human-robot collaboration. The Regulation becomes applicable on January 20, 2027.
The current EU Machinery Directive is a set of rules that member states are required to implement through national regulations. The Machinery Regulation replaces the Directive with uniform requirements across all EU member states without relying on national regulations. The Directive will be phased out by January 20, 2027, when it’s replaced by the Machinery Regulation (EU) 2023/1230 (Figure 1).
In addition to more uniform geographical coverage, the Machinery Regulation has an expanded scope and specific rules for new technologies. The Regulation mandates a holistic approach that integrates mechanical, electrical, and new digital safety and security measures, not only during the design process, but throughout the entire product lifecycle.
Products that include machine learning and evolve in such a way that, at some future date, they don’t meet Regulation requirements will need to undergo potentially extensive (and expensive) redesigns and recertifications.
Safety requirements can’t be satisfied through electrical and mechanical design alone. Digital security is also included. Machinery must have protection from data corruption from deliberate cyber-attacks as well as accidental failures. There must be secure connections for all networked functions, and logs of all interactions need to be maintained for traceability.
Risk assessment is an ongoing process beginning in the design phase, where it must be more dynamic and thorough, including new categories of hazards related to digital technology and the potential for substantial modification once the machine is in the field.
Under the category of substantial modifications, the Regulation states that any substantial modification, physical or digital, that increases existing risks or introduces new risks, makes the operator who initiates the changes, not the original equipment maker, responsible for obtaining a new conformity assessment and CE marking.
The Regulation adds stricter requirements for human-machine collaboration, including ergonomic design and minimizing psychological stress on operators, which requires designers to include human factors and ergonomics (HFE) considerations in machine designs.
The documentation requirements support digital operating instructions and declarations of conformity that can affect how information/document control and traceability systems are implemented in a wide range of machines (Figure 2). Documentation must be accessible, downloadable, and printable, even if the machine is offline. Availability must be supported for at least 10 years.
Dealing with AI and robotics
The EU Machinery Regulation (EU) 2023/1230 explicitly covers artificial intelligence (AI) and robotics, with special considerations for collaborative robots (cobots), and is designed to be used together with the EU AI Act and the Cyber Resilience Act to form a comprehensive regulatory framework.
There are specific requirements for human-robot interaction (HRI), including ensuring that robots can adequately respond to human commands (including, as appropriate, words, gestures, and HMIs), and that robot actions are predictable and understandable to operators.
Autonomous mobile robots (AMRs) are required to include monitoring functions that provide human supervisors with real-time information about machine activities and enable the supervisor to intervene as needed, including the ability to stop, reposition, or start the robot to ensure safety. Supervision can be implemented through direct communication with the machine or indirectly, using monitors like camera systems, if the machine’s movement and working area are fully observable.
So-called “safe fallback” modes are required. These enable operators to override or safely shut down AI-based functions as required.
Risk assessments must include the potential evolution of AI behavior when using self-learning or self-evolving machines and robots. Documentation for safety proofs must be included for possible future operational states, not just current capabilities.
In addition, manufacturers are required to maintain documentation relating to data governance practices, training data versions, and system design specifications to support traceability, and a detailed explanation of the AI’s decision-making process, which is necessary for maintenance, training, and incident analysis.
Finally, the new Regulation has expanded the concerns related to health and safety to include psychological stress or intimidation experienced when interacting with robots, not just physical injuries.
Summary
The EU Machinery Regulation includes significant changes that impact how machines are designed. It addresses emerging digital technologies like AI and ML, and it’s designed to be used together with the EU AI Act and the Cyber Resilience Act to form a comprehensive regulatory framework. It requires the availability of AI/ML training data, including considerations related to human factors, ergonomics, factors like machine or robot operator psychological stress or intimidation, and more.
References
A guide to the Machinery Regulation (EU) 2023/1230, Rockwell Automation
AI Act and Machinery Regulation: what changes for the safety of work equipment, Global Workplace Law & Policy
EU Machinery Regulation from 2027, Pilz
How AI Impacts the 2027 EU Machinery Regulation, TechWorks
Machinery Regulation and Remanufacturing: A Link Between Machinery Safety and Sustainability, MDPI machines
Machinery Regulation (EU) 2023/1230, European Union
Machinery Regulation (EU) 2023/1230, Intertek
New EU Machinery Regulation 2023/1230: Cybersecurity Now Mandatory, Nemko
Old and new Machinery Regulations: focus on maintenance and modifications to machinery and lines, Società di Industrializzazione Progettazione e Automazione
The Machinery Regulation(EU)2023/1230 vs. Machinery Directive 2006/42/EC – What Is New?, F2 Labs
The new EU Machinery Regulation 2023/1230: The most important points at a glance, iSAX
Timeline for the Machinery Regulation, Cedoc
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