EU Machinery Regulation, what changes for manufacturers and users

From 20 January 2027, Regulation (EU) 2023/1230 replaces the Machinery Directive and assigns the obligations of the manufacturer to anyone who substantially modifies a machine, including through its software. Safety requirements change, as do the role of harmonised standards and the rules for components based on artificial intelligence. Industry associations are calling for a postponement, while Italy is completing its national rules on penalties. For manufacturers, conformity procedures and design criteria change, while some reference documents are still to be published.

The current framework and what the Regulation changes

Today, machinery placed on the EU market must comply with Directive 2006/42/EC, known as the Machinery Directive. According to the Italian National Institute for Insurance against Accidents at Work, INAIL (2025), the reference criteria for modifications to machinery in use were those of the Blue Guide, the European Commission's guidance on implementing EU product rules. On 20 January 2027 the Directive is repealed and Regulation (EU) 2023/1230 applies directly in every Member State. Its new features include a definition of substantial modification and requirements for software. The European Commission (2026) is also preparing a new list of reference European technical standards.

The Machinery Regulation: scope, products and machinery already on the market

The Machinery Regulation, Regulation (EU) 2023/1230, sets the health and safety requirements for the design and construction of machinery and of the other products within its scope. It covers machinery and partly completed machinery, that is, assemblies which, taken on their own, cannot perform a specific application and are intended to be incorporated into a machine (European Parliament and Council, 2023).

The dividing line with the Directive is the date of placing on the market, meaning the first making available of a product in the Union. A machine that complies with the Directive and is placed on the market on 19 January 2027 may continue to be made available after that date. An identical machine placed on the market on 20 January 2027 must comply with the Regulation (European Parliament and Council, 2023).

Substantial modification and the obligations of the manufacturer

Under Article 3, point 16, a substantial modification is a physical or digital modification of a machine made after it has been placed on the market or put into service, which is not foreseen or planned by the manufacturer. It affects safety by creating a new hazard or increasing an existing risk. It requires guards or protective devices to be added, an operation that entails modifying the existing safety control system, or additional protective measures to ensure stability or mechanical strength (European Parliament and Council, 2023).

The Regulation assigns the obligations of the manufacturer to whoever carries out the modification. They first draw up the technical documentation, the file that gathers the evidence that the essential health and safety requirements are met. They then carry out the conformity assessment procedure and draw up the EU declaration of conformity, the document by which they take responsibility for compliance with the requirements. Finally, they affix the CE marking to the machine, the symbol that signals conformity to the market. A non-professional user who modifies their own machine for their own use is not considered a manufacturer (European Parliament and Council, 2023).

For certain categories of machinery and components, the conformity assessment cannot be carried out by the manufacturer alone. These categories are listed in Annex I, Part A, and include, for example, vehicle servicing lifts. In these cases a notified body is required, that is, a third-party body authorised by the Member States and notified to the Commission (European Parliament and Council, 2023).

Maintenance, adaptation, improvement and substantial modification

According to INAIL (2025), a substantial modification differs, on the basis of the criteria in the definition, from three other types of intervention on machinery in use. Maintenance, whether routine or extraordinary, preserves or repairs the machine in line with the manufacturer's instructions. Improvement increases safety at work on the basis of a specific risk analysis of the operating environment. Adaptation applies new technical provisions to machinery already placed on the market.

Software and essential safety requirements

A substantial modification can also be digital. The essential health and safety requirements are listed in Annex III of the Regulation, and two of them concern software specifically.

The first, in point 1.1.9, concerns protection against corruption. The machine identifies the installed software needed for safe operation and can provide information on that software at any time. It also collects evidence of any intervention on the software, legitimate or illegitimate, and of any modification of the installed software or its configuration (European Parliament and Council, 2023).

The second, in point 1.2.1, concerns control systems. They must withstand external influences, including reasonably foreseeable deliberate attempts by third parties, to the extent appropriate to the circumstances and the risks. Point (f) concerns safety software uploaded to the machine after it has been placed on the market. For each version uploaded, the Regulation allows a tracing log of interventions on the software to be kept for five years. The log may be used only to demonstrate conformity to a national authority that makes a reasoned request. The Regulation excludes any other use (European Parliament and Council, 2023).

Harmonised standards and the presumption of conformity

The Regulation sets general safety requirements. A harmonised standard, that is, a European technical standard whose references are published in the Official Journal of the European Union, translates them into technical specifications. A product that conforms to a harmonised standard is presumed to conform to the safety requirements that standard covers (European Parliament and Council, 2023). The references currently in force are those linked to the Directive, last updated on 4 September 2026, and the European Commission (2026) expects to publish the new list, linked to the Regulation, by the end of 2026.

Industrial robots and safety standards

Harmonised standards apply to specific products, such as the industrial robot. According to the International Organization for Standardization, ISO (2025), it is also partly completed machinery because, taken on its own, it cannot perform a specific application, such as welding or laser cutting. The term integrator usually refers to the company that installs it in a plant and combines it with other machinery or partly completed machinery to carry out one of those applications. If these elements operate as a single whole to achieve the same result, the assembly constitutes a machine. Under Article 3, point 18, the manufacturer of that machine is whoever designs or manufactures it, or has it designed or manufactured, and markets it under their own name or trademark. The same applies to whoever, under the same conditions, puts it into service for their own use (European Parliament and Council, 2023).

The reference harmonised standard is EN ISO 10218, the European version of ISO 10218, which the European Commission (2026) has included in the list linked to the Directive. According to ISO (2025), it sets the safety requirements for industrial robots, covering safe design, risk reduction measures and information for use. Part 1 covers the individual robot, before integration, and treats it as partly completed machinery, without covering hazards related to mobility when it is mounted on a mobile platform. Part 2 deals with integration into a more complex system. For dynamically stable mobile robots, ISO (2026) is preparing a dedicated standard, ISO 25785-1, which is still a draft.

Artificial intelligence and future requirements

Machine learning broadly refers to a technique by which a system changes its behaviour on the basis of experience. The categories in Annex I, Part A include safety components with fully or partially self-evolving behaviour using machine learning approaches that ensure safety functions. Machinery with embedded systems of this kind is also covered, in respect only of those systems. From 2027 these therefore require a notified body (European Parliament and Council, 2023). Requirements for artificial intelligence will follow through delegated acts, that is, acts by which the Commission supplements the Regulation. They are provided for by Article 8, as amended by Regulation (EU) 2026/1744. They concern artificial intelligence systems classified as high-risk under the EU Artificial Intelligence Act because they are safety components of products covered by the Machinery Regulation, or are themselves such products. The acts will apply by 2 August 2028 (European Parliament and Council, 2026).

Industry requests for a postponement

The software requirements are the subject of a request for postponement. In January 2026, four European manufacturers' associations asked for points 1.1.9 and 1.2.1(f) of Annex III to be postponed to 11 December 2027. The date is not a coincidence. On 11 December 2027 the Cyber Resilience Act, the EU regulation on the cybersecurity of products that can be connected to a network, also starts to apply. According to the associations, two Directorates-General of the Commission have confirmed that the cybersecurity risks covered by the Machinery Regulation must also comply with the Cyber Resilience Act. Aligning the dates would therefore avoid a double compliance effort. The associations also cite the timing of the harmonised standards, which are not expected before the end of 2026. They point as well to the lack of guidance on what market surveillance authorities expect from the tracing log (CECE, CECIMO, EGMF and FEM, 2026).

In an interview with Il Sussidiario (2026), Riccardo Rosa, president of UCIMU, the Italian association of machine tool, robot and automation manufacturers, is instead calling for a conditional extension of the entire Regulation, tied to clear technical objectives. Its reasons include the absence of sufficiently precise official guidance.

Penalties and the Italian implementing decree

The Regulation applies directly, but Article 50 leaves penalties to the Member States. Each Member State must lay down the rules on penalties for infringements by economic operators and notify them to the Commission by 20 October 2026. Penalties must be dissuasive and, for serious infringements, may be criminal (European Parliament and Council, 2023).

In Italy, the instrument is an implementing legislative decree. The Council of Ministers gave it preliminary approval on 2 October 2026, ahead of final approval. The text includes the penalty system and designates the Ministry of Enterprises and Made in Italy and the Ministry of Labour and Social Policies as market surveillance authorities. Administrative penalties are imposed by the Chambers of Commerce (Presidency of the Council of Ministers, 2026).

Consequences for machinery manufacturers

For manufacturers, the relevant date is the date on which each product is placed on the market. For machinery placed on the market from 20 January 2027, the conformity assessment, the technical documentation, the EU declaration of conformity and the CE marking follow the procedures of the Regulation. Design must take account of the software requirements in Annex III, namely the identification of the installed safety software, the collection of evidence of interventions and the resistance of control systems to external influences. For machinery and components listed in Annex I, Part A, including safety components with self-evolving behaviour based on machine learning, the involvement of a notified body must be planned. Anyone who integrates partly completed machinery into a plant and then markets it under their own name, or puts it into service for their own use, also becomes the manufacturer of the resulting machine (European Parliament and Council, 2023).

Documents still to be published and upcoming deadlines

The requirements on modifications and software apply together with the rest of the Regulation, but for those concerned the framework for applying them is not yet complete. Four documents have not yet been published. The list of harmonised standards under the Regulation, expected by the end of 2026, will indicate which standards give a presumption of conformity. The application guide, expected no earlier than that date, will clarify how its provisions should be interpreted. The Italian legislative decree, not yet given final approval, will set out the market surveillance authorities and penalties. The delegated acts, to apply by 2 August 2028, will add the requirements for high-risk artificial intelligence systems (European Commission, 2026; Presidency of the Council of Ministers, 2026; European Parliament and Council, 2026).

Sources

• European Parliament and Council (2023): Regulation (EU) 2023/1230 on machinery
• European Parliament and Council (2026): Regulation (EU) 2026/1744 (digital omnibus on artificial intelligence)
• European Commission (2026): Machinery (MD), harmonised standards page, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
• Presidency of the Council of Ministers (2026): Council of Ministers press release no. 191, 2 October 2026
• INAIL (2025): La macchina che cambia: tra modifica sostanziale, manutenzione e miglioramento, conference presentation, Bologna, 10 June 2025
• ISO (2025): ISO 10218-1:2025, Robotics, Safety requirements, Part 1: Industrial robots
• ISO (2026): ISO/CD 25785-1, Robotics, Safety requirements for dynamically stable industrial mobile robots, Part 1: Robots
• CECE, CECIMO, EGMF, FEM (2026): Request for postponement of the application of cybersecurity provisions in the Machinery Regulation (EU) 2023/1230
• Il Sussidiario (2026): Macchine industriali, sicurezza e competitività, interview with Riccardo Rosa, president of UCIMU, 31 July 2026