Key facts
- Applies from 20 January 2027: from that day, machinery placed on the market must comply with Regulation (EU) 2023/1230.
- Regulation, not directive: it applies directly in every EU member state – no national transposition and no transition period.
- Digital instructions allowed: instructions for use may be provided digitally – under clear conditions.
- New topics: cybersecurity, safety-related software, AI systems with self-evolving behaviour and substantial modifications are explicitly regulated.
What is the Machinery Regulation?
Regulation (EU) 2023/1230 on machinery products is the new legal framework for placing machinery and related products on the EU market. It replaces the Machinery Directive 2006/42/EC, which applied since 2009. Its goal is to adapt the rules to digitalisation, connected machinery and artificial intelligence and to apply them uniformly across the EU.
As a regulation, it applies directly in all member states. For manufacturers that means one set of rules for the entire single market – but no room for diverging national implementations either.
Timeline
| Date | Milestone |
|---|---|
| 29 Jun 2023 | Published in the Official Journal of the EU (L 165) |
| 19 Jul 2023 | Entry into force |
| 20 Jan 2024 | First provisions apply, e.g. on notified bodies |
| 20 Jan 2027 | Date of application – Machinery Directive 2006/42/EC is repealed |
What matters is the date of placing on the market: a machine first made available on the EU market from 20 January 2027 must meet the new requirements – even if it was designed under the old rules.
What changes compared to the Machinery Directive?
| Topic | Machinery Directive 2006/42/EC | Machinery Regulation 2023/1230 |
|---|---|---|
| Legal form | Directive, national transposition | Regulation, directly applicable |
| Instructions | generally on paper | digital permitted, under conditions |
| EU declaration of conformity | accompanies the machine | accompanies it or via internet address in the instructions |
| Cybersecurity | not explicitly covered | protection against corruption as an essential requirement |
| Software & AI | barely addressed | safety functions in software and self-learning systems explicitly covered |
| Substantial modification | not defined | defined – whoever substantially modifies is the manufacturer |
| High-risk machinery | Annex IV | Annex I, partly with mandatory third-party assessment |
The structure changes too: the essential health and safety requirements are now in Annex III. Update templates and checklists that refer to the old annex numbering.
Digital instructions: what is allowed?
One of the most practical changes: instructions for use may be provided in digital format. For this to be permissible, the manufacturer must in particular:
- indicate on the machinery – or, where that is not possible, in an accompanying document – how the digital instructions can be accessed,
- provide them in a format that can be downloaded, saved and printed,
- keep them accessible online for the expected lifetime of the machinery and at least 10 years after placing on the market,
- provide a paper version free of charge if the purchaser requests it at the time of purchase,
- for machinery intended for non-professional users, supply the safety information essential for safe commissioning and use on paper.
Instructions must be in a language easily understood by end users, as determined by the member state concerned. If you ship to several countries, you still need clean, consistent language versions.
Practical tip: digital instructions are more than a PDF on your website. What counts is long-term availability, an unambiguous link to the machine and its version, and the ability to produce a printable version at any time.
Technical documentation
Manufacturers must compile technical documentation before placing machinery on the market and keep it available for market surveillance authorities for at least 10 years. It includes, among other things:
- a general description of the machinery, overall drawings and circuit diagrams,
- the documented risk assessment and protective measures taken,
- standards and technical specifications applied, test reports and calculations,
- a copy of the instructions and of the EU declaration of conformity,
- for series production: the measures ensuring conformity.
The challenge is less about creating it once than about traceability over many years: which revision was shipped to which customer – and which instructions belong to it?
Substantial modification
Anyone who modifies machinery after it was placed on the market in a way that creates new hazards or increases existing risks makes a substantial modification – and is considered the manufacturer under the Machinery Regulation. This covers conversions, retrofits and modernisations, including those carried out by operators or service providers.
The consequence: conformity assessment, technical documentation and instructions must be updated for the modified machine. If your documentation is generated from engineering data, you can regenerate it in such cases instead of rewriting it.
Software, AI and cybersecurity
Today’s machinery is connected and software-controlled. The regulation reflects that:
- Protection against corruption: machinery must be designed so that connecting it to other devices or remote communication does not lead to hazardous situations. Safety-relevant software and data must be protected against manipulation.
- Control systems: for safety-related software, the regulation requires, among other things, records of interventions and of software versions uploaded.
- AI with self-evolving behaviour: safety components and machinery with fully or partially self-evolving behaviour using machine learning are among the high-risk categories requiring assessment by a notified body.
For connected digital products, the Cyber Resilience Act applies in addition, phased in from 2026 and 2027.
Checklist: how to prepare
- Review your portfolio: which machines will be placed on the market after 20 Jan 2027?
- Identify high-risk categories under Annex I and clarify the conformity assessment procedure.
- Extend your risk assessment to cybersecurity, software and, where relevant, AI.
- Adapt templates for instructions and the declaration of conformity to the new structure.
- Define your digital instructions strategy: access, format, availability for at least 10 years, paper on request.
- Ensure versioning: every machine shipped must be linked to its documentation revision.
- Secure your translation process for all target markets.
- Define a process for substantial modifications, retrofits and spare parts.
How proquodo helps with the Machinery Regulation
proquodo doesn’t replace legal advice or your risk assessment – but it takes over the part that costs the most time in practice: complete, consistent and versioned documentation.
| Requirement | How proquodo helps |
|---|---|
| Digital instructions, permanently available | Instructions and documents are available per machine in the online catalog – plus a printable PDF from the same source. |
| Link to machine and version | Every product version is immutable; every machine sees exactly its revision. |
| Multiple languages | Part names and content modules are maintained per language and reused. |
| Up to date after changes | Documents are regenerated from engineering data instead of updated by hand. |
| Platform security | Hosted in Europe, tenant isolation, two-factor sign-in, developed to OWASP ASVS. |
Note: this page provides a general overview and is not legal advice. The authoritative text is Regulation (EU) 2023/1230 in the Official Journal of the EU. The EU is also discussing simplifications, including for digital instructions – check the current status for your products.