Machinery Regulation (EU) 2023/1230 from 2027 — what the new “Machinery Directive” means for plants, maintenance and safety teams

Short answer: the regulation is addressed mainly to manufacturers, importers and distributors, but a production plant becomes subject to it in three situations: when it buys new machinery, when it builds a machine or line for its own use, and when it carries out a substantial modification of machinery already in use.

Everyday use of machinery is still governed by minimum requirements for work equipment: Directive 2009/104/EC and national rules (in Poland, the regulation on minimum OSH requirements for the use of machinery). The employer remains responsible for technical condition, inspections, workstation instructions, operator training and occupational risk assessment, regardless of when a machine was bought.

For purchasing, from 20 January 2027 the EU declaration of conformity for new machinery should refer to Regulation (EU) 2023/1230 rather than Directive 2006/42/EC. It is worth adding this condition to 2026 purchase specifications for machines delivered after that date.

Short answer: a substantial modification is a change to machinery after it has been placed on the market or put into service, not foreseen or planned by the manufacturer, that affects safety by creating a new hazard or increasing an existing risk and requires added protective measures involving the control system or new guards. The definition is set out in Article 3 of the regulation.

The consequence is significant: whoever carries out a substantial modification — including an employer upgrading a machine in-house — is treated as the manufacturer for the modified part, or for the whole machine if the change affects its overall safety. They must perform risk assessment and conformity assessment, prepare technical documentation, instructions and a declaration of conformity, and affix the CE marking.

Typical maintenance situations that need analysis: adding a robot to an existing line, changing PLC logic in safety circuits, increasing drive speed or power, removing or rebuilding guards, or combining machines into an assembly with shared controls. Replacing a worn part with an identical or equivalent one, maintenance and repair according to the manufacturer's instructions are generally not substantial modifications.

The boundary can be blurred, so the decision should not be made on the shop floor. A simple procedure works well: describe the planned change, check whether a new hazard appears or risk increases, whether existing safeguards suffice, and record a justified decision signed by a responsible person. In VIMS EHS this workflow runs in the management of change (MOC) module, linked to updating the occupational risk assessment.

Short answer: yes, the regulation allows instructions for use in digital form, for example via a web address or a QR code on the machine, with conditions. On the buyer's request at the time of purchase, the manufacturer must provide a paper copy free of charge, and digital instructions must remain accessible for the machine's lifetime and at least 10 years after it was placed on the market. Safety information for non-professional users is still supplied on paper.

Manufacturer instructions must be distinguished from the workstation safety instruction the employer prepares under national OSH law. The regulation changes the form of the manufacturer's document; it does not release the plant from giving operators an up-to-date safe operating instruction at the workstation.

Digital form solves the problem of lost binders but creates a new one: the operator needs the right version when they need it. In VIMS EHS, QR and NFC access points on the machine lead to its record, and the instructions and procedures module stores the workstation instruction, LOTO procedure and manufacturer documentation with version history. See also QR codes and NFC tags in workplace safety.

Short answer: the regulation adds an essential requirement for protection against corruption of the control system — connecting a machine to another device or network, including remote access, must not lead to a hazardous situation. Safety-critical software and data must be protected against accidental or intentional interference, and the machine must collect evidence of interventions in that software.

Control systems are also covered: a fault, logic error or loss of communication must not block the emergency stop or disable safety functions such as light curtains or guard interlocks. The regulation also addresses machinery with fully or partially self-evolving behaviour or logic — systems using machine learning — and some of them fall into categories requiring assessment by a notified body.

Practical conclusions for a plant: treat PLC software changes as technical changes, with a version log, an approver and a safety impact assessment. Manufacturer remote service should follow access rules agreed with IT. Technical details of protection, including the choice of harmonised standards, require consultation with a machinery safety and automation specialist.

Short answer: no. Machinery placed on the market in compliance with Directive 2006/42/EC before 20 January 2027 does not need new conformity assessment just because the rules changed. Older machines must, however, meet the minimum requirements for the use of work equipment and be kept in safe working order.

The exception is a substantial modification carried out after 20 January 2027 — the modified machine is then assessed under the new rules. A machine register should therefore cover not only purchase date and declaration of conformity but also the modification history with a decision on whether each change was substantial.

Technical condition is confirmed by periodic checks, inspections per the manufacturer's instructions and, for equipment under statutory technical supervision, official inspections. In VIMS EHS the registers and inspections module keeps machine records, inspection schedules with reminders and phone checklists; similar principles are described in forklift inspections.

Short answer: preparation covers four areas — inventory of machinery and documentation, digital access to instructions at the workstation, a technical management of change procedure, and network security and energy isolation rules. None of them requires buying new machines.

Step 1 — inventory: list machines, assemblies and partly completed machinery, their declarations of conformity or incorporation, manufacturer instructions and the person responsible for each. Step 2 — document access: tag machines with QR codes or NFC tags leading to current workstation instructions and manufacturer documentation.

Step 3 — management of change: require every upgrade, software change or guard rebuild to go through an MOC request assessing whether it is a substantial modification. Step 4 — network and energy: agree remote access rules for controllers with IT and update LOTO procedures for machines upgraded in recent years.

Purchasing completes the picture: specifications for machines delivered after 20 January 2027 should require compliance with Regulation (EU) 2023/1230, define the language and form of instructions and how digital documentation is handed over.

Essential requirements are the health and safety requirements in Annex III of the regulation that a manufacturer must meet when placing machinery on the market. Minimum requirements apply to employers using machinery and come from Directive 2009/104/EC and national law.

Partly completed machinery cannot perform a specific application on its own and is intended to be incorporated into machinery — it is supplied with a declaration of incorporation and assembly instructions. An assembly of machinery is several machines linked to function as a whole, such as a production line with shared controls, and is assessed as a whole.

A notified body is an independent organisation designated to assess conformity of high-risk machinery categories listed in Annex I. A safety component is a hardware or software part that performs a safety function and whose failure endangers persons. EN ISO 12100 remains the basic standard for machinery risk assessment; the list of standards harmonised with the regulation is published by the European Commission.