For years, the machinery industry has been rapidly integrating advanced digital technologies, moving away from purely mechanical systems toward smart, autonomous equipment. Today, advanced machinery is increasingly less dependent on human operators, capable of real-time information processing, problem-solving, and adapting to unstructured environments.
Recognizing that the emergence of Artificial Intelligence (AI), the Internet of Things (IoT), and robotics presented new product safety challenges, a 2020 European Commission Report concluded that the old Directive 2006/42/EC contained significant gaps. To close these gaps, Regulation (EU) 2023/1230 explicitly covers the safety risks stemming from these new digital technologies.
For safety engineers and managers, this Regulation introduces a paradigm shift. Here is how you must navigate the new safety frontiers of AI and autonomous machinery.
One of the most critical updates for safety professionals is the treatment of AI and machine learning under the new Annex I. The Regulation acknowledges that systems with self-evolving behavior possess characteristics—such as data dependency, opacity, and autonomy—that might considerably increase the probability and severity of harm.
Under Annex I, Part A, the following are now classified as high-risk items requiring a stricter conformity assessment procedure:
Because these fall under Part A, safety engineers must now secure mandatory third-party conformity assessment for these systems. It is important to note that these strict rules apply specifically to systems using machine learning capable of evolving; they do not apply to traditional software programmed only to execute static, automated functions.
Under the new Regulation, the mandatory risk assessment process is no longer just about the machine's state when it leaves the factory. Safety managers must ensure that the risk assessment addresses the machine's entire lifecycle.
Crucially, the risk assessment must now include hazards that might arise due to an intended evolution of the machine's behavior as it operates with varying levels of autonomy. When designing control systems for self-evolving machinery, engineers must ensure that:
With AI making autonomous safety decisions, accountability requires transparency. Regulation (EU) 2023/1230 introduces stringent data recording requirements for safety engineers to implement in control systems:
As robots and AI-driven machines leave cages and enter shared workspaces, human-machine coexistence becomes a primary safety concern. The Regulation mandates that the psychological stress caused by interacting with machinery must be reduced, adapting the design to both shared spaces without direct collaboration and direct human-machine interaction.
Safety engineers must design the human-machine interface to adapt to the machine's varying levels of autonomy. In practice, this means autonomous machines must be designed to respond to people adequately (e.g., verbally through words, or non-verbally through gestures and movement). Furthermore, the machine must be able to communicate its planned actions—specifically what it is going to do and why—to operators in a clear and comprehensible manner.
For autonomous mobile machinery, safety managers must ensure the implementation of a specific "supervisory function". This remote surveillance system must allow a supervisor to receive alerts about unforeseen or dangerous situations and issue limited commands, such as stopping, starting, or moving the machine to a safe position. If this supervisory function is inactive, the machinery must not be able to operate.
Machinery Regulation (EU) 2023/1230 forces safety professionals to look beyond static mechanical risks and engineer safety into the very logic and data of evolving systems. By understanding the rigorous third-party assessment requirements for Annex I AI systems, implementing robust data logging, and prioritizing transparent human-machine communication, safety managers can ensure their innovative machinery remains compliant and safe in the digital age.