Machinery Directive vs New Machinery Regulation
A practical comparison of Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230 for machinery manufacturers, system integrators, retrofit projects and compliance professionals.
The new Regulation makes software, cybersecurity, AI-based safety functions and substantial modification much more explicit.
This page summarises the key changes and explains their practical impact for engineering and compliance decisions.
What changes in practical engineering terms?
The new Machinery Regulation does not only change legal form. It also makes digital safety components, software traceability, cyber-resilience, AI-based control systems and substantial modifications more visible in conformity assessment.
Direct applicability
The Regulation applies directly, reducing the scope for divergent national transposition.
Safety software becomes visible
Digital components and software that perform safety functions are now explicitly addressed.
Protection against manipulation
Safety-related control systems must consider reasonably foreseeable malicious third-party attempts.
Substantial modification defined
Physical and digital modifications after placing on the market can trigger manufacturer obligations.
From Directive to directly applicable Regulation.
The transition affects how manufacturers, importers, distributors, integrators and operators plan compliance work for machinery and related products.
Machinery Directive 2006/42/EC
Implemented through national transposition across Member States.
Machinery Regulation (EU) 2023/1230
Introduces direct applicability and updated requirements for modern machinery risks.
Application date
The new Regulation applies from 20 January 2027.
Detailed comparison by topic.
Each item below compares the former Directive position with the new Regulation, followed by the practical impact and the explicit citation location provided for the new Regulation.
Legal nature
Directive requiring national transposition.
Regulation with direct application.
Less room for divergent national interpretations.
Art. 1–2
Machinery installations / assemblies
Assemblies of machinery were already covered.
Still covered; additionally, an assembly is also covered where only the intended software still needs to be installed.
Software becomes a visible legal element of the machinery concept.
Art. 3(1)(d) and (f)
Safety component
Mainly physical components in practice.
Now expressly also digital components including software.
Safety software becomes CE-relevant.
Art. 3(3)
List of safety components
Classical hardware was foregrounded.
Newly explicit: “software that performs safety functions”.
Software itself can qualify as a safety component.
Annex II No. 18
Self-evolving safety components
No express regulatory case.
New: safety components with self-evolving behaviour using machine learning approaches.
AI/ML-based safety systems are expressly covered.
Annex II No. 19; Annex I Part A No. 6
Control systems / manipulation
Protection against faults and external influences in general.
Additionally requires protection against “reasonably foreseeable malicious attempts by third parties”.
Safety-relevant manipulation is now expressly part of machinery law.
Annex III 1.2.1(a)
Safety-relevant software evidence
Not expressly structured as a separate evidentiary block.
Installed safety-relevant software must be identifiable; interventions and changes to software/configuration must be logged.
Software versioning, configuration changes and interventions become auditable.
Annex III 1.1.9 / 1.2.1
Substantial modification
Not legally defined.
For the first time legally defined as an unforeseen physical or digital modification after placing on the market / putting into service that creates a new hazard or increases a risk.
Retrofit and software changes are clearly captured.
Art. 3(16)
Legal consequence of substantial modification
Previously handled mainly through guidance and practice.
The person making the substantial modification is treated as manufacturer and must apply the appropriate conformity assessment procedure.
Highly relevant for rebuilders, integrators and retrofit projects.
Art. 18
Digital instructions for use
Paper was the standard form.
Instructions for use may be provided in digital form; they must be accessible and capable of being printed, downloaded and saved.
Digitalisation is allowed, but not without limits.
Art. 10(7)
Paper obligation despite digitalisation
Paper instructions typically accompanied the machine.
On user request, a paper version must be supplied free of charge within 1 month; for non-professional users, essential safety information must be provided on paper.
User protection remains despite digitalisation.
Art. 10(7), second and third subparagraphs
CE marking – principle
CE marking under the Directive.
General CE marking principles follow Regulation (EC) No 765/2008.
Systematic integration into the general EU product safety framework.
Art. 23
CE marking – affixing
Before placing on the market / putting into service.
CE marking must be visible, legible and indelible; otherwise on packaging and accompanying documents.
Formal requirements are more precise.
Art. 24(1)–(2)
Notified body identification number
Previously more narrowly framed.
The identification number of the notified body must appear after the CE marking in the relevant third-party procedures.
Visible indication of external conformity assessment involvement.
Art. 24(3)
High-risk systematics
Annex IV.
New split into Annex I Part A and Part B.
More differentiated treatment of risk-relevant product categories.
Art. 6; Annex I
Conformity assessment for Part A
Former Annex IV logic.
For Annex I Part A, only procedures involving a notified body: Modules B+C, H or G.
No pure internal production control for Part A.
Art. 25(2)
Conformity assessment for Part B
Internal production control possible under conditions.
For Annex I Part B, Module A is possible, but only where harmonised standards or common specifications fully cover the relevant requirements; alternatively B+C, H or G.
More precise, but not automatically stricter in every case.
Art. 25(3)
AI / autonomous control systems
No express standalone regulatory block.
For systems with self-evolving behaviour: limitation of action space, recording of safety-relevant decisions and the possibility of correction at any time.
Learning systems are allowed only under strict safety conditions.
Annex III 1.2.1, subparagraph on self-evolving control systems
Four areas deserve particular attention.
The new Regulation gives more explicit legal visibility to digital and post-market changes that were previously handled mainly through interpretation, guidance and good engineering practice.
Direct legal framework
More consistent application across the EU and closer alignment with the wider product safety framework.
Safety software evidence
Software identification, interventions and configuration changes become part of the compliance evidence trail.
Manipulation risk
Reasonably foreseeable malicious attempts must be addressed where they affect safety-relevant systems.
Substantial modification
Physical and digital modifications after placing on the market can create new manufacturer obligations.
Plan your transition to the Machinery Regulation.
ExConform supports manufacturers, OEMs, integrators and operators with CE conformity assessments, machinery regulation gap reviews, technical files, functional safety evidence and training.