Key health and safety requirements of the Machinery Regulation 2023/1230.

The primary aim of the Machinery Regulation 2023/1230 is to ensure the safe use of all machinery and similar products placed on the market and to eliminate risks to people, property or the environment. To this end, the Regulation sets out the essential health and safety requirements, which form the basis of the entire machinery safety framework. The aim of these requirements is to prevent accidents and other hazardous situations arising from the use of machinery, as well as to protect users and other persons within the machinery’s operating area.

Health and safety requirements form a central part of the Machinery Regulation, as they govern the design, manufacture and use of machinery. Manufacturers must take them into account at the design stage and ensure the safety of machinery throughout its entire service life.

Annex IV to the Machinery Regulation also requires the manufacturer to draw up technical documentation for the machinery, containing information on the health and safety requirements that have been applied to the machinery.

Verification of the technical documentation facilitates supervision by the authorities and enhances transparency regarding how the safe operation of machinery has been ensured. Within the framework of the Machinery Regulation, the essential health and safety requirements are set out in Annex III, which corresponds to Annex I of the previous Machinery Directive 2006/42/EC.

The Regulation takes into account modern technologies, such as artificial intelligence, automation and machine learning, as well as the associated safety risks. A significant difference from the previous Directive is that the Regulation also requires a risk assessment of self-organising behaviour, which implies, for example, safety checks on machinery using artificial intelligence.

The Regulation emphasises safety requirements for autonomous machines, i.e. devices that can operate independently or without constant supervision by a user or driver. New obligations have been imposed on autonomous machines concerning the reliability of control systems, cybersecurity and human–machine interaction.

The machine must be able to communicate its operations to the user in a comprehensible manner, so that the decision-making process remains predictable and controllable.

Autonomously operating equipment must have a control function that allows the operator to receive information remotely and, if necessary, to start or stop the equipment.