From the Machinery Directive to the Machinery Regulation: Software-related innovations

On June 29, 2023, Regulation (EU) No. 1230/2023 (hereunder also referred to as "Machinery Regulation" or simply "Regulation") was published in the Official Journal of the European Union. 

The legislative novelties bring innovative scope to the entire sector of production and distribution of so-called "machinery" in all EU Member States, aligning, among other things, with recent European trends in sustainability. 

Its publication marks the conclusion of the nearly two decades experience of Directive 2006/42/EC, the Machinery Directive, adopted at the time to harmonize safety and health protection requirements related to so-called "machinery" among all EU Member States.

In line with the most recent European legislation, it is worth noting the choice to adopt the instrument of the Regulation, instead of the Directive. A Regulation is a binding legislative act characterized by mandatory nature in all its elements and, above all, by its direct applicability. 

This way, the possibility of discrepancies in the regulation of the same subject matter at the Union level - often observed during the transposition of European directives by individual Member States - will be eliminated, ensuring the highest degree of regulatory harmonization.

Although already formally in force, the Machinery Regulation will have full effect - definitively repealing the Machinery Directive - from January 14, 2027, the date from which economic operators in the sector will be required to fully comply with the new objectives and essential requirements prescribed by the Regulation.

Among the several innovations implemented to the previous legislation, the Regulation especially focuses on all aspects related to software, an essential component of machinery currently on the market, assigned to the management of increasingly complex, delicate, and virtually essential tasks.

The new imprint is evident from the definitions of the Regulation, which have been adapted to the technological and digital evolution of the sector. Specifically:

Similarly, the innovative spirit of the Regulation is evident with regard to essential safety and health protection requirements, which manufacturers must comply with in the design and construction of the machinery. 

In addition to the traditional requirements already provided by the previous Machinery Directive, entirely new requirements have been introduced, taking into account the delicate role played by software in current and next-generation machinery.

Firstly, the so-called "protection against corruption" must be guaranteed. Therefore, the machine shall be designed in such a way that the connection of any device communicating with it does not result in a hazardous situation. In addition, the hardware components of the machine that allow access to the software critical for the compliance of the machinery to essential health and safety requirements, shall be designed in such a way so that is adequately protected against corruption (both accidental and intentional), and the machine must collect evidence regarding legitimate or illegitimate interventions on such components, making them easily accessible.

Even the requirement for the design of the so-called "control systems" has been profoundly influenced by the need to ensure their protection in modern work environments, which will be achieved by designing the machine to withstand, among other things, deliberate attempts by third parties that could lead to a hazardous situation. 

The objective of this regulatory prescription is, in fact, to prevent possible faults and manipulations that concern not only hardware but also - if not, especially - software.

A further and particularly forward-thinking novelty is represented by the unprecedented regulation of control systems of machines with self-evolving behavior or logic (even only partially). 

In order to ensure the safety of such systems, additional rigorous design requirements have been provided, particularly regarding the decision-making process (especially concerning safety) of machines equipped with self-evolving logics.

Finally, even the provisions relating to technical documentation - which must be stored, and eventually exhibited at the request of the competent supervisory authorities, by economic operators in the sector - have been amended to take into account new digital needs. 

Specifically, the technical documentation must also contain the source code or programming logic of the security-related software, in order to demonstrate the machine's compliance with the Regulation.

The transition from the Machinery Directive to the Machinery Regulation marks an important novelty in the European regulatory landscape, introducing new provisions aimed at ensuring the safety and conformity of machinery, with particular attention to the increasingly crucial role of software.

The newly introduced changes pose challenges and opportunities for industry operators, in relation to which it will be fundamental to manage the criticalities and potentialities of the innovations brought by the Regulation, paying due and indispensable attention to the associated documentation and contractual compliance, adapting in time for the full application of the Regulation starting from January 14, 2027.​​​