The EU Machinery Regulation (EU) 2023/1230
On 20 January 2027 the Machinery Directive stops and the Machinery Regulation starts. There is no transition period. If you place machinery on the EU market from that date, it is assessed against Regulation (EU) 2023/1230 — new essential health and safety requirements, a restructured high-risk list, and for the first time explicit obligations covering cybersecurity and machine learning in safety functions.
Hard cutover. No dual-compliance window.
The Machinery Directive, in force since 2009.
Annex I Part A — notified body mandatory.
Technical file and declaration, after placing on the market.
What it covers
The Regulation applies to machinery and to related products. That second term is new and it matters, because it replaces the old patchwork of separate categories with one defined set:
- Interchangeable equipment
- Safety components
- Lifting accessories
- Chains, ropes and webbing
- Removable mechanical transmission devices
Partly completed machinery keeps its separate treatment: a declaration of incorporation rather than a declaration of conformity, assembly instructions rather than an operator manual, and no CE marking of its own.
The five changes that create actual work
1. It is a regulation
Directly applicable in every Member State on the same day, with no national transposing law. The practical effect: no more checking twenty-seven implementations, and no more waiting for a Member State to act. The rules are the rules, everywhere, on 20 January 2027.
2. Digital and cybersecurity requirements in Annex III
The essential health and safety requirements now address the case where a safety function can be corrupted. Control systems must be designed so that machinery cannot be put into a hazardous state by malicious or accidental interference with software or data. Evidence of the protective measures belongs in your technical file. For connected machinery, this sits alongside — and often overlaps with — the Cyber Resilience Act.
3. Machine learning in safety functions is now a named category
Two of the six Annex I Part A high-risk categories are about self-evolving behaviour using machine learning approaches that ensure safety functions. If your safety function learns, you are in mandatory notified body territory, full stop — applying harmonised standards does not get you out of it. The six categories →
4. The high-risk list was restructured
The old Annex IV of the Directive became Annex I, split into Part A and Part B. Part A is the six categories where a notified body is always required. Part B is the much longer list where self-assessment remains available provided harmonised standards are applied in full. For many manufacturers this is a net loosening — several categories that previously forced third-party involvement now do not.
5. Digital instructions are allowed
Instructions may be supplied in digital format. Two conditions bite: the manufacturer must state how to access them and provide a paper version free of charge on request, and for machinery intended for non-professional users the safety information must be supplied in paper form. Do not read "digital instructions are allowed" as "the manual is now a web page and we are done".
Substantial modification
What you have to produce
- A risk assessment, carried out iteratively, identifying the hazards, estimating and evaluating the risks, and recording the protective measures. How to do it →
- Technical documentation per Annex IV, demonstrating conformity with the Annex III essential health and safety requirements. What Annex IV requires →
- Instructions for use in the language of the Member State where the machinery is placed on the market.
- The EU declaration of conformity per Annex V, or a declaration of incorporation for partly completed machinery. Required content →
- The CE marking, affixed visibly, legibly and indelibly. Marking rules →
Get told when the requirements change
None of the 35 CRA harmonised standards is published yet. When they land — and when deadlines move — we email you. No more than twice a month.
What to do now
Directive to Regulation
A clause-level view of what changed, what stayed, and which of your existing documents survive the cutover.
Read →Annex I Parts A and B
The six mandatory notified body categories, and the Part B list where self-assessment still works.
Read →The Annex IV technical file
Everything the file must contain, in the order an assessor will look for it.
Read →Risk assessment
The iterative method, the three-step hierarchy, and what the record has to show.
Read →Declaration of conformity
Annex V content, plus the declaration of incorporation for partly completed machinery.
Read →Technical file template
An Annex IV-structured file with every section laid out and guidance notes throughout.
See the template →