Machinery Regulation readiness check: is your company ready for Regulation (EU) 2023/1230?
From 20 January 2027 the Machinery Regulation (EU) 2023/1230 applies mandatorily to every machine newly placed on the EU market, with no parallel phase alongside the Machinery Directive. This self-assessment checks in ten questions the points where the transition fails in practice: from the cut-over roadmap through Annex I and cybersecurity to digital operating instructions, technical documentation and the new declaration templates.
Is your CE planning aligned to 20 January 2027?
From 20 January 2027 the Machinery Regulation (EU) 2023/1230 applies mandatorily and replaces the Machinery Directive 2006/42/EC without a parallel phase. Machinery placed on the market from that day needs conformity with the Machinery Regulation, including the new EU Declaration of Conformity.
The ten topics this check covers
Each question goes back to a concrete obligation under Regulation (EU) 2023/1230; the reference is given in each case.
1. Is your CE planning aligned to 20 January 2027?
From 20 January 2027 the Machinery Regulation (EU) 2023/1230 applies mandatorily and replaces the Machinery Directive 2006/42/EC without a parallel phase. Machinery placed on the market from that day needs conformity with the Machinery Regulation, including the new EU Declaration of Conformity.
2. Have you classified your portfolio by the product categories of the Machinery Regulation?
The Regulation distinguishes machinery, partly completed machinery and related products (Article 2). New: safety components can also be digital, meaning software with a safety function that is placed on the market separately is a safety component (Article 3(3)).
3. Do you know whether your products fall under Annex I (Part A or B)?
Annex I Part A always requires a notified body (internal production control alone is never sufficient). For Part B, self-assessment is permitted only if the relevant harmonised standards or common specifications are applied in full (Article 25(3)).
4. Have protection against corruption and the new control system requirements been assessed?
Annex III No 1.1.9 requires safety-relevant hardware and software to be protected against accidental and intentional corruption (including evidence of interventions); No 1.2.1 explicitly extends control system safety to fully or partially self-evolving behaviour (AI).
5. Is your process for digital operating instructions ready for the Regulation?
Operating instructions may be provided in digital form (Article 10(7)): access must be indicated on the product, they must be printable, downloadable and saveable, and they must remain online for the expected lifetime, at least ten years. On request at the time of purchase, a paper copy must be supplied free of charge within one month; for (also foreseeably) non-professional users, the essential safety information must be provided on paper.
6. Do you systematically assess changes for a substantial modification?
The Regulation defines substantial modification in law for the first time and expressly includes digital modifications (Article 3(16)): even a software update can create a new hazard. Whoever substantially modifies a machine takes on the manufacturer's obligations for it (Article 18).
7. Does your technical documentation comply with Annex IV of the Regulation?
The technical documentation must be kept available for ten years; on reasoned request of the authorities, the source code or programmed logic of safety-relevant software must also be provided (Article 10(3)). For sensor-based or autonomous functions, their characteristics, capabilities and limits must be documented.
8. Are your declarations of conformity and incorporation prepared for the Regulation's templates?
Annex V introduces new template structures: EU Declaration of Conformity (Part A) and EU Declaration of Incorporation (Part B) with a statement of responsibility and references to standards including their date; where standards are applied in part, the parts applied must be stated. Both declarations may be provided digitally and must then remain available online for at least ten years.
9. If you supply partly completed machinery: do your assembly instructions match Annex XI?
The Regulation replaces the brief Annex VI of the Directive with a structured minimum content of 14 items (Annex XI No 2 points (a) to (n)), from conditions for incorporation and residual hazard topics to the version indication. The EU Declaration of Incorporation is enclosed or accessible via an internet address or machine-readable code in the assembly instructions (Article 11(8)).
10. Do you continuously monitor the harmonisation of standards under the Regulation?
As of August 2026, no harmonised standards with presumption of conformity under the Machinery Regulation are yet listed in the Official Journal. Until then, conformity rests solely on your risk assessment and the documented application of the state of the art; once citations appear, they decide whether self-assessment is permitted for Annex I Part B products.
Further reading
- Machinery Directive vs. Machinery Regulation: the complete comparison with all references, including the Part A/Part B quick check and the gap analysis checklist as PDF (checklist PDF in German).
- EU Machinery Regulation 2027: overview for machinery manufacturers
- Substantial modification of machinery: when you become the manufacturer
The check is guidance based on Regulation (EU) 2023/1230 and the Guide to application of the Machinery Directive (Ed. 2.3); it does not replace legal advice. Status of the standards situation (harmonised standards under the Machinery Regulation in the Official Journal): August 2026.