Machinery Directive and Machinery Regulation, point by point.
Machinery Directive 2006/42/EC applies to machinery placed on the market up to and including 19 January 2027. From 20 January 2027, Machinery Regulation (EU) 2023/1230 applies directly in every member state, with no national transposition. Four changes matter most: digital instructions become permissible, cybersecurity becomes a requirement in its own right, software performing a safety function counts as a safety component, and substantial modification is regulated in the legal text for the first time.
Two names, one body of rules, one cut-off date. Much of what is being designed today will be placed on the market after 20 January 2027, which means the new requirements have to be planned for now. This page puts both legal acts side by side and separates what actually changes from what merely gets a new name.
One cut-off date, no transition period
The regulation was published in the Official Journal of the EU on 29 June 2023 and applies from 20 January 2027. Until then the Machinery Directive remains in force.
The switch is binary. There is no gliding transition during which either set of rules could be chosen. What counts is the moment of placing on the market: a machine first made available on 19 January 2027 falls under the directive. On 20 January 2027 the regulation applies, even where the design work was finished years earlier.
For running projects that means checking the planned delivery date rather than the design date.
Eight points compared directly
On the left, the basis machinery is built on today. On the right, the basis that applies from 20 January 2027.
| Criterion | Machinery Directive 2006/42/EC | Machinery Regulation (EU) 2023/1230 |
|---|---|---|
| Legal formCHANGED | DIRECTIVE 2006/42/ECA directive. Each member state transposes it into national law, in Germany through the Product Safety Act. | REGULATION (EU) 2023/1230A regulation. It applies directly in every member state, with no national transposition and no divergence in interpretation between countries. |
| Scope in timeCHANGED | DIRECTIVE 2006/42/ECFor machinery placed on the market up to and including 19 January 2027. | REGULATION (EU) 2023/1230For machinery placed on the market from 20 January 2027. What counts is placing on the market, not the design date. |
| InstructionsCHANGED | DIRECTIVE 2006/42/ECSupplied with the machine in paper form. | REGULATION (EU) 2023/1230May be supplied digitally provided they can be downloaded and printed. A printed version must be supplied on request, and for non-professional users the safety information stays mandatory on paper. |
| CybersecurityNEW | DIRECTIVE 2006/42/ECNot regulated in its own right. | REGULATION (EU) 2023/1230A requirement in its own right. Control systems must be protected against corruption, unintentional and deliberate alike, including external interfaces. |
| SoftwareNEW | DIRECTIVE 2006/42/ECNot covered as a safety component in its own right. | REGULATION (EU) 2023/1230Software performing a safety function counts as a safety component and carries the corresponding obligations. |
| Self-evolving behaviourNEW | DIRECTIVE 2006/42/ECNot provided for. The directive assumes fixed behaviour after commissioning. | REGULATION (EU) 2023/1230Covered. Risks arising from self-evolving behaviour belong in the risk assessment. |
| Substantial modificationNEW | DIRECTIVE 2006/42/ECNot defined in the legal text. Interpretation rested on guidance documents and national position papers. | REGULATION (EU) 2023/1230Regulated in the legal text. Whoever substantially modifies a machine takes on the obligations of the manufacturer. |
| High-risk categories and conformity assessmentCHANGED | DIRECTIVE 2006/42/ECAnnex IV lists the categories subject to a special procedure. | REGULATION (EU) 2023/1230Annex I lists them in two parts. Part A requires a notified body. For Part B, internal production control remains possible where the harmonised standards are applied in full. |
NEW marks a requirement that did not exist before. CHANGED marks one that existed and now reads differently. A third category is deliberately absent: none of the eight rows is a pure renaming.
This comparison summarises. It does not replace the text of the regulation.
Four rows that create work
- Cybersecurity reaches into the interfaces
- Protection against corruption does not stop at the control system. The ways in are covered too: USB ports and remote maintenance access. In practice that means extending the risk assessment by an attack path it never knew, and making decisions that used to sit with IT.
- Safety-relevant software does not age with the machine
- Where software is a safety component, that applies well beyond the initial delivery. Every later change falls under it. Anyone rolling out updates today without a documented rationale needs a process that makes the change traceable.
- Self-evolving behaviour moves the moment of assessment
- Until now the risk assessment was tied to commissioning. For a machine whose behaviour keeps developing afterwards, that moment is no longer the last one. The assessment has to anticipate later development, even though it cannot be observed at the time of delivery.
- Substantial modification hits the operator, not only the manufacturer
- Whoever substantially modifies a machine takes on the manufacturer's obligations. In practice that often means in-house retrofits, new control software or linking machines together. Under the directive the boundary was a matter of interpretation. Now it is in the legal text.
What this means for engineering
The change does not stop at the legal department. Four points land directly in engineering and technical writing.
First, projects delivering from 2027 onward need a decision now on which set of rules they are documented against. Second, anyone planning to ship instructions digitally needs a process that guarantees availability and printability across the machine's life. Third, safety-relevant software needs a traceable change history. Fourth, the standards referenced in the technical documentation have to be checked for whether they still hold.
The fourth point is the most laborious and the one most often underestimated.
Which versions of which standards are actually in your documents?
The European Commission is currently reviewing the harmonised standards to establish whether they still confer presumption of conformity under the new regulation. This affects the newly added topics in particular, which existing standards cannot cover without revision.
Before that question can even be answered, another one comes first: which standards do your own drawings, specifications, risk assessments and instructions cite, in which version, and in which place? In most companies this has grown over decades and is spread across many repositories. It is not a legal question. It is a question put to a body of documents.
That is exactly where KoAssist comes in. You put the question to your own documents and get the answer with file, page and section as evidence. The result is a record of where something was found, not a statement of conformity: KoAssist shows you the place. The judgement stays with you.
This page reflects research as of 23 August 2026 and does not replace legal advice. Only the text of the regulation is binding.
What gets asked most before the cut-off date
The answers refer to machinery and related products within the scope of the regulation.
When does the Machinery Regulation apply?
From 20 January 2027. It was published back on 29 June 2023. Until 19 January 2027, Machinery Directive 2006/42/EC continues to apply.
Do we have to retrofit machinery placed on the market before 2027?
No. What counts is the moment of placing on the market. A machine lawfully placed on the market before the cut-off date remains so afterwards. The picture changes if it is substantially modified later.
Can instructions be shipped digitally only from 2027?
Digital is permitted provided the instructions can be downloaded and printed. A printed version must be supplied on request, and for non-professional users the safety information stays mandatory on paper. So digital without a fallback is not an option.
What happens to the harmonised standards?
They are currently being reviewed to establish whether they still confer presumption of conformity under the regulation. Until that review is complete it stays open which versions have to be referenced from 2027. For manufacturers that mainly means knowing their own inventory of referenced standards.
What applies if we substantially modify existing machinery?
Whoever substantially modifies a machine takes on the obligations of the manufacturer. The regulation states this explicitly, whereas the directive carried no definition in the legal text. Retrofits involving new control software fall under this more often than a project initially assumes.
Less searching.
More engineering.
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