The New Machinery Regulation (EU) 2023/1230: What Changes for Plant Engineering
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 European Union. It replaces the Machinery Directive 2006/42/EC, which has been in force since 2006 – and not just on paper: unlike a directive, a regulation does not need to be transposed into national law. It applies directly in all EU member states. For manufacturers in plant engineering, this means a fully harmonized legal framework – but also new obligations.
Why was the Machinery Directive revised at all?
The previous directive proved stable for almost two decades. But the technological reality has changed fundamentally since then:
Artificial intelligence and autonomous systems – self-learning algorithms, cobots, and driverless transport systems simply were not covered by the original framework.
Connectivity (Industry 4.0/IoT) – new attack vectors that go beyond classic machine safety.
Digitalization of documentation – digital instruction manuals were not previously provided for.
Added to this are legal-systematic reasons (alignment with the European New Legislative Framework, coherence with the AI Regulation and the Cybersecurity Regulation) as well as practical experience: interpretation questions regarding the distinction between complete and partly completed machinery repeatedly caused legal uncertainty.
Regulation instead of Directive – the key difference
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 harmonization |
National law | 9th ProdSV (German Machinery Ordinance) | No national transposition required |
The most important changes at a glance
Expanded scope: Safety components with digital functions and remote monitoring systems now explicitly fall under the regulation.
New legal terms: For the first time, "substantial modification" of a machine is legally defined – a term that previously caused much interpretive dispute. "Safety component" has also been redefined and now explicitly includes software.
Software and autonomous machines: Self-learning systems must be designed so that machine behavior remains safe even after learning. For the first time, explicit cybersecurity requirements are imposed – machines must be protected against unauthorized interference, and manipulation must be detectable. Autonomously operating machines must independently reach a safe state in the event of communication or sensor failure.
Digital documentation: Instruction manuals and declarations of conformity may in future be provided digitally – accessible for at least 10 years, with access e.g. via QR code. Consumers retain the right to a free paper version.
New conformity assessment modules: The regulation introduces an NLF module structure (Module A – internal production control, Modules B+C – EU type-examination, Module H – full quality assurance, Module G – unit verification). Particularly relevant: for certain high-risk machinery with AI-based safety functions, self-declaration alone (Module A) is no longer sufficient – even if a harmonized standard is fully complied with.
Substantial modification: Anyone who makes a substantial modification to a machine legally becomes the manufacturer – with all manufacturer obligations: a new risk assessment, updated technical documentation, a renewed conformity assessment procedure, a new declaration of conformity, and CE marking.
Timeline: Key deadlines you should know
Date | Event |
29.06.2023 | Published in the EU Official Journal |
19.07.2023 | Regulation enters into force |
14.07.2024 | Provisions for notified bodies and authorities take effect |
20.01.2027 | General application date – Directive 2006/42/EC is repealed |
Until 19.01.2027, manufacturers may still place products on the market entirely under the old Directive 2006/42/EC. Anyone who has already placed products on the market in compliance with the directive before this deadline benefits from grandfathering.
What does this mean for you as an engineer in plant engineering?
The new regulation particularly affects you if you work with connected, autonomous, or AI-supported plant components – and on the topic of substantial modification, which is often underestimated in practice. There is time until 2027, but internal processes (risk assessment, technical documentation, conformity assessment) can already be gradually adapted today.
The e-book "CE Marking in Plant Engineering" provides:
a complete assessment scheme to determine, case by case, whether a substantial modification is present
the complete mandatory content for declarations of conformity and incorporation as an editable template
a step-by-step guide to applying the new module structure (A, B+C, G, H)
Comments