International markets
Machinery Regulation (EU) 2023/1230: preparing for the transition
Practical guide for manufacturers: what to update before Machinery Regulation (EU) 2023/1230, from technical file to cybersecurity.
Regulation (EU) 2023/1230 represents the new European legislative reference for machines and related products. It is not a simple formal update of Directive 2006/42/EC: it introduces a more modern structure, directly applicable in all Member States and more suitable for interconnected machines, autonomous systems, advanced software and digital documentation.
The date for manufacturers is 20 January 2027. From that moment on, Machinery Directive 2006/42/EC will be repealed and the new inputs on the market will have to be managed according to the Machinery Regulation. This means that the transition must be started before, not when the new regime is already mandatory.
Why start now
The conformity of a machine is not updated by changing only the legislative reference in the declaration of conformity. It is necessary to verify the whole process: risk analysis, essential health and safety requirements, applied standards, technical file, instructions for use, EU declaration of conformity, tests and internal procedures. Reference
For a standardized machine the work can be relatively neat. For a range of machines, a complex system or a line with software and remote connections, the transition requires method, technical times and coordination between technical office, automation, documentation, quality and commercial.
What changes with regard to the Machinery Directive
The passage from Directive to Regulation makes the text directly applicable and reduces the margin of national interpretation. Some technical requirements are also changed and important innovations are introduced: the Regulation introduces greater attention to the risks arising from new technologies, to the protection against corruption of digital systems, autonomous machines, collaborative environments and to the management of digital documentation.
Areas to check in the gap analysis
Risk analysis and RESS
The first control must concern the analysis of risks. It is necessary to check whether hazards, hazardous situations and risk reduction measures are still adequate compared to the requirements of the Regulation. The methodology of EN ISO 12100 remains the technical starting point to build a consistent and defensible assessment.
Cybersecurity and protection against corruption
Annex III’s 1.1.9 requirement introduces the issue of protection against corruption. For connected machines, controlled by software, upgradeable remotely or integrated into industrial networks, the manufacturer must assess whether accidental or intentional corruption can compromise machine safety.
Software, autonomous systems and AI
When a machine integrates autonomous functions, advanced algorithms or software that influence safety functions, the manufacturer must demonstrate that the behaviour of the machine remains within predictable and safe limits. This concerns both the project and the validation and the documentation kept in the technical file.
Digital instructions for use and EU Declaration of Conformity
The Regulation allows the use of instructions in digital format, but not in a free way and without constraints. Instructions must be accessible, downloadable, printable, available for an appropriate period and provided free of charge in paper on request in the cases provided. The EU declaration of conformity must also be managed consistently.
Substantial changes
The Regulation clarifies the concept of substantial modification better. For those who change machines already placed on the market, it will be essential to distinguish between maintenance, improvement, retrofit and modification that creates new hazards or increases existing risks, therefore requiring a new assessment of conformity. Reference
Operating plan for manufacturers
- Mapping machine families and identifying the most critical ones for complexity, software, automation and target markets.
- Perform a gap analysis between current documentation and requirements of 2023/1230 Regulation.
- Update the risk assessment, technical file, instructions for use and declarations, starting with the highest-volume or most complex machinery.
- Check safety circuits and Performance Levels where design changes impact safety functions.
- Define a business procedure for digital documentation, paper copies upon request and storage of documents.
- Form technical office, automation, documentation and trade on new responsibilities.
- How Waves Engineering supports manufacturers
- Waves Engineering supports manufacturers in the transition to Machinery Regulation with a practical approach: we start from existing documentation, we identify gaps, we define priorities and build a sustainable adjustment plan for the company.
- Our support may include regulatory gap analysis, risk analysis update, performance level review, technical file adjustment, instructions for use editing, testing and internal technical training.
FAQ
When does Machinery Regulation (EU) 2023/1230 apply?
It applies from 20 January 2027. Until this date, Directive 2006/42/EC continues to apply for machines placed on the market according to the current system.
Do I have to update all the machines already sold?
In general, the Regulation applies to products newly placed on the market. Machines already placed on the market before its application date do not automatically require recertification, unless specific cases such as substantial changes or new obligations apply.
Where do you want to leave?
From the gap analysis of technical documentation: risk analysis, technical file, instructions for use, declaration of conformity, applied standards and test reports.
