Key takeaways
Most compliance articles about the new Machinery Regulation are written for machine builders. If you run a plant rather than sell machines, the honest summary is shorter, and the one obligation that can land on you is the one nobody talks about.
Regulation (EU) 2023/1230 was adopted on 14 June 2023 and applies from 20 January 2027. On that date it replaces Directive 2006/42/EC, the Machinery Directive that has governed CE marking for machinery since 2006.
Two structural differences matter.
First, it is a regulation, not a directive. A directive has to be transposed into each member state's national law, which is why the same requirement could read slightly differently in Germany and in Poland. A regulation applies directly and identically in every member state on the same day.
Second, there is no transition period. There is no window in which you may choose between the old rules and the new ones. Machinery placed on the market before 20 January 2027 under the old Directive remains lawful and can still be made available. Machinery placed on the market or put into service after that date has to meet the Regulation.
So the practical answer for an operating plant is: your installed base is fine. You are not required to retrofit or recertify machines that were compliant when you bought them. The obligation attaches to what happens next.
Article 18 of the Regulation says that a natural or legal person who carries out a substantial modification of machinery is considered to be a manufacturer for the purposes of the Regulation, and is subject to the manufacturer obligations in Article 10. That person has to declare conformity on their own responsibility and apply the relevant conformity assessment procedure.
Read that again with a maintenance hat on. Your engineering team removes a fixed guard and fits a light curtain. Your automation contractor rewrites the PLC logic so a machine can run in a faster mode. You bolt a second station onto an existing line. In each case a person, and it may be your own employer, has changed the machine after it was placed on the market.
The concept existed under the old Directive as accepted guidance. The Regulation puts it in the legal text and makes it explicit that a modification can be physical or digital. Article 3(16) defines a substantial modification as a change made after the machine was placed on the market that was not foreseen by the manufacturer and that creates a new hazard or increases an existing risk to the point where new or modified guards or protective measures are needed.
The test is not how big the job was. The test is what it did to the risk.
| What you did | Usually not substantial | Likely substantial |
| Replaced a worn bearing or motor with an equivalent part | Yes, this is maintenance | |
| Added a vibration sensor that only reads data | Yes, if it cannot act on the machine | |
| Increased line speed beyond the original design envelope | Yes, new or increased risk | |
| Changed safety related PLC logic or bypassed an interlock | Yes, this is a safety function change | |
| Added a robot or a new station to an existing line | Yes, new hazard zone | |
| Enabled a remote or automatic operating mode that did not exist | Yes, new operating mode |
The middle rows are where plants get into trouble, because a control system change looks like a software task and gets treated like one. It is signed off in a ticket, not in a risk assessment, and nothing in the machine file records that the machine is no longer the machine the supplier certified.
High risk machinery moves to Annex I Part A. For the categories listed there, a manufacturer's own declaration is no longer enough. A notified body has to carry out the conformity assessment before the product goes on the market. If you build or substantially modify something in that list, self-certification is off the table.
Instructions may be digital. The Regulation allows instructions for use and the EU declaration of conformity to be supplied in digital form. Two conditions come with that: they have to stay accessible online for the expected lifetime of the machine and for at least ten years after it was placed on the market, and a buyer who asks for a paper copy has to receive one free of charge.
Cybersecurity and software behaviour are in scope. Safety functions must be protected against corruption, whether accidental or deliberate. Machines whose behaviour evolves through machine learning are addressed directly rather than left to interpretation.
A packaging plant runs a filler bought in 2018 with a valid CE mark. In March 2026 the engineering team fits a servo driven changeover kit and rewrites part of the PLC program so the machine can switch formats without stopping. Throughput rises by nine percent, and the team is rightly pleased.
They have almost certainly performed a substantial modification. A new automatic movement exists in a zone an operator reaches into during changeover, which is a new hazard. Under the Regulation the plant, not the original builder, carries the manufacturer obligations for that modified machine: risk assessment, technical file, conformity assessment, declaration and marking.
None of that is exotic work. It is unpleasant only when it has to be reconstructed two years later, from memory, after an incident. Which is the whole point of what follows.
None of this is new administrative burden invented by Brussels. It is the documentation a competent maintenance function keeps anyway, which is why plants with a working preventive maintenance programme tend to find this transition uneventful.
Every item on the list above is a record, and records are exactly what a maintenance system exists to keep. Machine history, work orders, approvals, the parts that went in, the dates, the people. If you also track OEE, you have the performance context around a modification too, which is useful when you have to show that a change did what it was supposed to do without introducing a new failure mode. Our note on the outgoing Machinery Directive covers the regime that is being replaced.
This article is general information, not legal advice. For a specific modification, take specialist advice.
Book a demo to see how machine history, modifications and maintenance records sit on one asset file.
Machinery compliance is not the only EU reporting wave reaching the shop floor: see our guide to ESRS E1 energy reporting for manufacturers for what plants must start tracking.
Regulation (EU) 2023/1230 applies from 20 January 2027. It was adopted on 14 June 2023 and replaces Directive 2006/42/EC on that date, with no transition period afterwards.
No. Machinery placed on the market before 20 January 2027 in accordance with the Machinery Directive stays lawful and can continue to be made available. The Regulation applies to machinery placed on the market or put into service after that date, and to machinery that is substantially modified.
A change made to machinery after it was placed on the market, not foreseen by the original manufacturer, that creates a new hazard or increases an existing risk so that new or modified protective measures are needed. It can be mechanical or digital, which means changes to software, control logic or operating modes count.
Under Article 18, the person who carries out the substantial modification is considered the manufacturer for that machinery and takes on the manufacturer obligations in Article 10, including conformity assessment and the declaration of conformity. A non-professional user modifying machinery for their own private use is excluded.
Yes. The Regulation allows digital instructions and a digital declaration of conformity, provided they stay accessible online for the expected lifetime of the machine and at least ten years after it was placed on the market, and provided a paper copy is supplied free of charge to a buyer who asks for one.
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