Regulation & compliance
Regulation (EU) 2023/1230
Replaces the Machinery Directive from 20 January 2027, directly applicable in every EU member state.
EU Machinery Regulation (EU) 2023/1230
- Category
- Regulation & compliance
- Scope
- EU
- Edition / refs
- Applies from 20 January 2027
MSA output
- Risk assessment (EN ISO 12100)
- CE Technical File
- PLr / SIL calculations & validation protocols
- Built for 2027
What is Regulation (EU) 2023/1230?
Regulation (EU) 2023/1230 on machinery replaces the Machinery Directive 2006/42/EC. It was published in the Official Journal on 29 June 2023, entered into force on 19 July 2023 and applies from 20 January 2027. As a Regulation it is directly applicable in every member state, without national transposition.
The essential health and safety requirements are carried over and updated in Annex III, with new or revised requirements on protection against corruption, safety and reliability of control systems, autonomous mobile machinery, human–machine interaction and machinery with self-evolving behaviour. The Regulation also aligns machinery with the EU New Legislative Framework, including explicit obligations for importers and distributors.
Who it applies to
- Machine builders and OEMs placing machinery on the EU market from 20 January 2027
- System integrators creating assemblies or supplying partly completed machinery
- Anyone who substantially modifies machinery — they take on the manufacturer’s obligations
- Importers and distributors of machinery
Key requirements
- 01
Updated EHSRs (Annex III)
Including protection against corruption of safety functions and the safety and reliability of control systems, considering malicious attempts by third parties.
- 02
Substantial modification
A physical or digital modification, not foreseen by the manufacturer, that affects safety by creating a new hazard or increasing an existing risk. The person who carries it out is treated as the manufacturer.
- 03
High-risk machinery (Annex I)
Part A categories require notified-body conformity assessment. Part B categories may use internal production control where harmonised standards are fully applied.
- 04
Technical documentation (Annex IV)
Part A for machinery, Part B for partly completed machinery, kept for at least 10 years.
- 05
Digital instructions
Instructions may be supplied in digital form, with a paper copy free of charge if the customer requests it at the time of purchase. Essential safety information must be on paper for non-professional users.
- 06
EU Declaration of Conformity
Annex V sets the content of the EU Declaration of Conformity; partly completed machinery is accompanied by a Declaration of Incorporation.
Summary for orientation only. Always refer to the current official text of Regulation (EU) 2023/1230 and any applicable legislation.
MSA for Regulation (EU) 2023/1230
What MSA generates
Evidence produced from your engineering inputs, traceable end to end and exported to Word, PDF or Excel.
Risk assessment (EN ISO 12100)
Risk assessment structured to the harmonised method, ready to be revisited for 2027 requirements.
CE Technical File
Technical documentation generated from your engineering inputs, with full traceability.
PLr / SIL calculations & validation protocols
Control-system evidence for each safety function.
Built for 2027
MSA is designed to be ready for the EU Machinery Regulation when it applies in 2027.
Frequently asked questions
When does Regulation (EU) 2023/1230 apply?
From 20 January 2027. A small number of provisions, such as those on notified bodies, apply earlier.
Can I keep using the harmonised standards I use today?
Presumption of conformity under the Regulation comes from harmonised standards whose references are published in the Official Journal under the Regulation. Monitor the Commission’s lists as references are published, and check the edition you apply.
Does the Regulation apply to machinery already in service?
Not retroactively. It applies to machinery placed on the market or put into service from 20 January 2027, and to machinery that is substantially modified. The use of existing equipment at work is governed by the Work Equipment Directive 2009/104/EC — and PUWER in Great Britain.
What does “self-evolving behaviour” mean?
It refers to safety components, and machinery with embedded systems, that use machine learning approaches to ensure safety functions and whose behaviour can evolve. These are listed in Annex I Part A and require third-party conformity assessment.
Generate Regulation (EU) 2023/1230 evidence from your own data
See how MSA turns your requirements, drawings and process data into certification-ready documents — fully offline.