Political agreement was reached in the European Parliament on December 15, 2022. The Council of Europe approved the text of the Machine Regulation on January 25, 2023. The European Parliament's Committee on the Internal Market and Consumer Protection voted on March 2, 2023. In its plenary session on April 18, 2023, the European Parliament voted on the Machinery Regulation. The publication in the Official Journal of the EU took place on June 29, 2023.

Main reasons for revising the Machinery Directive 2006/42/EC:

• Continuing to ensure the smooth functioning of the internal market.
• Creating a level playing field for economic operators and maintaining the competitiveness of the mechanical engineering sector on global markets.
• Creating a high level of trust in digital innovative technologies for consumers and users.
• Adapting to the risks of the new digital technologies.
• Fostering innovation.
• Reducing costs for industry, especially for SMEs (small and medium-sized enterprises), saving natural resources.
• Digital instructions and EU Declaration of Conformity.
• Regulation through essential health and safety requirements, supported by harmonized standards cited in the EU Official Journal.

The Machinery Directive does not adequately cover the new risks arising from emerging technologies. In order to strengthen trust in digital technologies, legal certainty must be provided in relation to these technologies.

These risks are:

• the growing number of collaborative robots.
• the growing number of machines that are connected to the Internet.
• the way in which software updates affect the behavior of the machine after it has been placed on the market.
• the risk assessment for machine learning applications.
• the growing number of autonomous machines (without drivers or operators) and remote monitoring.

Legal uncertainty arose due to a lack of clarity regarding the scope of application, definitions and possible security gaps in traditional technologies. This includes the manufacturers' understanding of the correct legal framework to apply (overlaps or inconsistencies with other relevant EU legislation).

Specifically, these are:

• concerns about the definition of "partly completed machinery" and its distinction from "machinery".
• clarification of the exclusion of means of transport.
• clarification of the exclusion of some products with WLAN functions.
• dealing with significant changes to machines.

Legal uncertainty for manufacturers also arose due to divergences in the interpretation of the Machinery Directive as a result of its transposition into the national law of the member states. Some member states wanted to extend the conformity assessment of high-risk machinery through third-party certification. It was necessary to update the list of high-risk machines. The new rules for the provision of machine documentation was necessary due to monetary and ecological costs on the one hand, and new technological developments in IT infrastructure on the other.

The elimination of inconsistencies with other European Union legislation on product safety became necessary as there is no harmonization of the Machinery Directive with the EU’s New Legislative Framework (NLF).

A regulation must be applied directly by the Member States. National adaptations and interpretations are thus avoided. Legal clarity is therefore improved.

With a directive, the member states have more options for national interpretation and adaptation to achieve the goals. The consequences of different interpretations of a directive in different countries can, however, also result in legal uncertainties for users, such as machine manufacturers who export their machines and systems to different countries in the European Union.

European Commission: EUR-Lex - 32023R1230 - EN - EUR-Lex (europa.eu).

The new regulation will apply from January 20, 2027.

Anyone who combines components, partly completed machinery or several machines to form an assembly of machinery (i.e. in a coordinated system) becomes a manufacturer and must therefore fulfill the requirements of the Machinery Regulation, carry out a corresponding conformity assessment, and declare the conformity of the assembly. This can be the manufacturer of an assembly of machinery or system integrator, but also an operator himself.

According to Article 3 Definitions, "machinery" also means an assembly of machinery (...) or partly completed machinery which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole. “Partly completed machinery” means an assembly which is machinery but for the fact that it cannot in itself function so as to perform a specific application and which is only intended to be incorporated into or assembled with machinery or other partly completed machinery or equipment, thereby forming a machinery product.