Machinery Regulation (EU) 2023/1230
From 20 January 2027, manufacturers will only be allowed to place on the market machinery and mechanisms that comply with the new requirements in mechanical engineering – Regulation 2023/1230.
Rapid technological changes are transforming the manufacturing industry and beyond, creating new opportunities in industrial automation, occupational health and safety.
Regulation 2023/1230 extends the scope of application to products in two areas, including:
machines that have undergone ‘significant modifications’;
digital components of machinery, including software.
Logic blocks that collectively enable safety functions in the relevant development systems must be implemented using specific validation procedures. This does not pose a direct problem for manufacturers, but it does highlight the central role that software plays in ensuring the safety of machinery.
The Regulation introduces two new roles: importer and distributor, who are assigned specific responsibilities for ensuring that products comply with the established requirements, and sets higher requirements for product information and documentation, which must be easily understandable to both users and market surveillance authorities.
The burden of compliance falls entirely on the manufacturer, who becomes solely responsible.
Experience gained in applying Directive 2006/42/EC has revealed the need to address shortcomings and inconsistencies in product coverage and conformity assessment procedures, which has been taken into account in the Regulation.
It was also considered necessary to address the protection of animals and the environment, greater attention is paid to the differences between professional and non-professional users, i.e. ‘consumers’, so that manufacturers take into account that the latter may not have the same knowledge and experience as the former, and the most advanced developments in robotics, which provide for ever-increasing interaction between operators and machines, have been taken into account. The new Regulation devotes considerable space to partially assembled machinery.
The essential safety requirements previously contained in Annex I are now included in Annex III and have virtually identical numbering.
Existing harmonised standards will remain unchanged, except for the changes that normally occur.
The Machinery Regulation (EU) 2023/1230 introduces a number of significant changes compared to the previous Machinery Directive 2006/42/EC. These changes are aimed at improving safety, updating standards to reflect technological advances and simplifying certain aspects of the regulatory framework. The main differences are:
• A more risk-based approach, requiring manufacturers to conduct a comprehensive risk assessment before placing equipment on the market. This includes analysing all potential hazards associated with the use of the machine and documenting all measures taken to reduce these risks.
• It emphasises digital documentation, requiring technical documentation to be available in electronic format. This makes it easier to access and update information.
• It places greater responsibility on manufacturers, importers and distributors to ensure that equipment complies with safety standards and that these standards are maintained throughout the equipment's life cycle.
• Regulation 2023/1230 introduces specific cybersecurity requirements to protect machines from cyber attacks, ensure data protection and prevent unauthorised use.
• expands the definition of ‘machinery and mechanisms’ to include partially assembled machines and certain safety components, as well as some assembly systems and devices.
• clarifies and simplifies some existing rules, making it easier for companies to understand and implement the necessary provisions.
• includes a requirement for technical documentation in electronic format, which must be accessible, searchable and printable so that all interested parties can verify product compliance at any time.
The declaration of conformity and technical file must be stored in digital format, with specific requirements for their structure and storage.
