The New Machinery Regulation (EU) 2023/1230: What Changes for Plant Engineering
On 29 June 2023, Regulation (EU) 2023/1230 on machinery was published in the Official Journal of the EU. For manufacturers in plant engineering it means a fully harmonised legal framework, and new obligations.
The regulation replaces the Machinery Directive 2006/42/EC, in force since 2006. Unlike a directive, a regulation does not need to be transposed into national law. It applies directly in all EU member states.
Why was the Machinery Directive revised?
The directive proved stable for almost two decades, but the technology has changed fundamentally:
- Artificial intelligence and autonomous systems: self-learning algorithms, cobots and driverless transport systems were not covered by the original framework.
- Connectivity (Industry 4.0, IoT): new attack vectors beyond classic machine safety.
- Digital documentation: digital instructions were not previously provided for.
There were also legal-systematic reasons, such as alignment with the New Legislative Framework, and practical ones: the distinction between complete and partly completed machinery repeatedly caused legal uncertainty.
Regulation instead of directive
| Aspect | Directive 2006/42/EC | Regulation (EU) 2023/1230 |
|---|---|---|
| Legal effect | indirect, national transposition required | direct in all member states |
| National deviations | possible | not permitted |
| Uniformity | differences between countries possible | full harmonisation |
| German law | 9th ProdSV | no transposition required |
The most important changes
New legal terms: "Substantial modification" of a machine is legally defined for the first time. "Safety component" has been redefined and now explicitly includes software.
Software and autonomous machines: Self-learning systems must be designed so that the machine's behaviour remains safe after learning. Machines must be protected against unauthorised interference, and interference must be traceable.
Digital documentation: Instructions and the declaration of conformity may be provided digitally. On request, the instructions must still be supplied on paper free of charge.
Conformity assessment modules: The regulation adopts the New Legislative Framework modules (A internal production control, B and C type-examination, H full quality assurance, G unit verification). For machinery listed in Annex I Part A, self-declaration under module A is no longer sufficient, even if a harmonised standard is fully applied.
Substantial modification: Anyone who substantially modifies a machine becomes its manufacturer, with all obligations: a new risk assessment, updated technical documentation, a new conformity assessment, a new declaration of conformity and CE marking.
Key dates
| Date | Event |
|---|---|
| 29.06.2023 | Published in the Official Journal of the EU |
| 19.07.2023 | Regulation enters into force |
| 20.01.2027 | General date of application, Directive 2006/42/EC repealed |
Until 19 January 2027, manufacturers may still place products on the market under the directive.
The e-book CE marking in plant engineering contains an assessment scheme for substantial modification, the mandatory content of declarations of conformity and incorporation as editable templates, and a guide to applying the modules.
This article is a technical working aid. It does not replace reading the legal texts or individual advice.