Machinery Regulation 2023/1230: modifying an existing machine without unintentionally becoming its manufacturer

Technical corner · Machine safety · 5 min read

Replacing a PLC, adding a robot, increasing line speed: these projects are part of life in every plant. From 20 January 2027, they will take place under a new framework. Regulation (EU) 2023/1230 replaces the Machinery Directive 2006/42/EC. Because it is a regulation, it applies directly and in the same way in every EU country, with no national transposition.

The question that matters most to plant operators is simple: when I modify an existing machine, do I become its manufacturer?

What changes, in short

• Substantial modification is defined in the text. The Directive did not mention it: it was a matter of guidance and interpretation.
• Cybersecurity becomes a safety requirement. Remote access or malicious software must not be able to make a safety function dangerous.
• Instructions can be digital. A paper version is still due if the buyer requests it at the time of purchase.
• Some high-risk machinery must go through a notified body, for example safety components whose behaviour evolves autonomously.

Retrofit, robot, speed: substantial or not?

Under the Regulation, a modification is substantial when three conditions are met: it was not foreseen by the original manufacturer, it creates a new hazard or increases an existing risk, and it requires adding safeguards that modify the safety control system, or measures for stability or mechanical strength.

A few pointers, to be confirmed case by case:

• Replacing an obsolete PLC with identical functions, without touching the safety functions, generally creates no new hazard. The assessment should still be written down and kept.
• Adding a robot or a workstation in an existing area often creates a new hazard that requires new safeguards: the modification is likely to be substantial.
• Increasing speed or throughput can increase an existing risk (energy, stopping time, safety distances): assess it before the trials.

If the modification is substantial

Whoever carries it out is considered the manufacturer of the modified machine. They must redo the risk assessment, compile the technical file, draw up the EU declaration of conformity and affix the CE marking. It is not insurmountable, but it must be built into the project schedule and budget.

4 actions to start now

1. List the modification and retrofit projects planned for 2026 and 2027.
2. For each one, write a short assessment: substantial modification, yes or no, and why.
3. In the specifications of your new machines, require compliance with Regulation 2023/1230 for any delivery after 20 January 2027.
4. Inventory remote access to your PLCs and the safety functions it can reach.

How ITS can help

ITS supports manufacturers on these projects: written assessment of the modification, update of the risk assessment and of the essential requirements checklist under Regulation 2023/1230, retrofit of automation and safety systems, documentation. Example: the complete revamping of a Biko unwinder, with a new PLC, door safety status shown on screen and up-to-date electrical diagrams.

A modification project coming up? Let’s talk before work starts.

This article gives an overview and does not replace an assessment of your machine or legal advice.