Machinery Regulation guide
Machinery Directive vs. Machinery Regulation: what really changes
Directive 2006/42/EC applies until 19 January 2027, Regulation (EU) 2023/1230 from 20 January 2027 onwards. The comparison point by point, and what it means for documentation, the declaration of conformity and the operating manual.
In short
Directive 2006/42/EC had to be transposed nationally and applies until 19 January 2027; Regulation (EU) 2023/1230 applies directly in all Member States from 20 January 2027. The safety requirements remain essentially the same. New are the digital operating manual and declaration of conformity, cybersecurity and self-evolving control requirements, the statutory definition of substantial modification (Art. 3(16)), mandatory third-party assessment for Annex I Part A machinery and dedicated obligations for importers and distributors.
Directive or regulation: the formal difference with practical consequences
The Machinery Directive had to be transposed into national law by every Member State, which produced 27 slightly different versions and interpretations. The Machinery Regulation applies directly in every Member State without a national act: one legal basis, one wording, one declaration of conformity with one legal reference.
Cut-off date without a transition period
The Regulation applies from 20 January 2027 (Art. 54 as corrected; the originally published text said 14 January). Until 19 January 2027 only the Directive applies, from 20 January only the Regulation. What counts is the placing on the market or putting into service of the individual machine, not the year of construction or the contract date. Machinery lawfully placed on the market under the Directive remains marketable; there is no retrofitting obligation.
The comparison point by point
The essential health and safety requirements remain largely the same (Annex I of the Directive becomes Annex III of the Regulation). The differences lie in the obligations of economic operators, in documentation and in three new topics:
- Operating manual: Directive — paper, digital only as a supplement. Regulation — digital permitted (Art. 10(7)), with access details on the machine, paper on request free of charge within one month, safety information in paper form for machinery intended for non-professional users, online availability for at least ten years.
- Declaration of conformity: Directive — Annex II Part 1 A, must accompany the machine. Regulation — Annex V Part A, accompanying document or internet address / machine-readable code in the manual (Art. 10(8)), standards with the Official Journal date, Module A statement, no longer the person authorised to compile the technical file.
- Assembly instructions and declaration of incorporation: Directive — Art. 13, Annex VI and Annex II B, paper. Regulation — Art. 11(7) and (8), Annex XI and Annex V B, both permitted in digital form.
- Cybersecurity: Directive — not regulated. Regulation — Annex III 1.1.9 "Protection against corruption" requires safety functions to be protected against accidental or intentional manipulation via network connections; Annex III 1.2.1 extends the requirements for control systems accordingly.
- Artificial intelligence: Directive — not regulated. Regulation — self-evolving control systems with safety functions are addressed in Annex III; safety components with fully or partially self-evolving behaviour are listed in Annex I Part A and require a notified body.
- Substantial modification: Directive — national interpretation papers only. Regulation — legally defined in Art. 3(16) as a physical or digital modification after placing on the market that creates a new hazard or increases a risk; whoever carries it out is deemed a manufacturer under Art. 18.
- High-risk machinery: Directive — Annex IV, type-examination avoidable with full application of harmonised standards. Regulation — Annex I Part A with mandatory third-party assessment regardless of standards (Art. 25(2)), Annex I Part B with the previous choice (Art. 25(3)).
- Economic operators: Regulation — dedicated obligations for importers (Art. 13) and distributors (Art. 15), such as checking CE marking, declaration of conformity and instructions before making machinery available.
What stays the same
CE marking, the iterative risk assessment, technical documentation kept for ten years, harmonised standards with presumption of conformity, the manual in the official language of the country of use and the manufacturer as self-declaring party all remain. Module designations A, B, C, G and H are unchanged. EN ISO 12100 and EN ISO 20607 keep their role.
What manufacturers have to change before January 2027
A short list for manufacturers who already work cleanly under the Directive:
- Switch the declaration of conformity template to Annex V Part A: legal reference (EU) 2023/1230, standards with dates, module statement, remove the documentation representative.
- Decide whether the operating manual will be delivered digitally, then organise the access details on the machine, ten-year availability and the paper-on-request process.
- Extend the risk assessment to cybersecurity and, where relevant, self-evolving control systems.
- Check whether the machine falls under Annex I Part A, which requires a notified body regardless of standards.
- Define a process for substantial modifications, now that the definition is statutory and covers software changes.
- For partly completed machinery, adapt assembly instructions and declaration of incorporation to Annex XI and Annex V Part B.
FAQ
Frequently asked questions
What is the difference between the Machinery Directive and the Machinery Regulation?
The Directive 2006/42/EC had to be transposed nationally and applies until 19 January 2027. The Regulation (EU) 2023/1230 applies directly from 20 January 2027. New are the digital operating manual, cybersecurity and self-evolving control requirements, the statutory definition of substantial modification, mandatory third-party assessment for Annex I Part A machinery and dedicated obligations for importers and distributors.
Does the Machinery Directive still apply?
Yes, for all machinery placed on the market or put into service up to and including 19 January 2027. From 20 January 2027 only the Regulation applies, with no transition period.
Do I have to recreate my documentation from scratch?
No. Risk assessment, technical documentation and operating manual keep their structure. What needs adapting is the declaration of conformity under Annex V Part A, the legal references, possibly the risk assessment for cybersecurity, and the decision on digital delivery of the manual.
Legal basis and sources
What this page is based on
- Regulation (EU) 2023/1230 on machinery (Machinery Regulation) — EUR-Lex
- Corrigendum to Regulation (EU) 2023/1230, OJ L 169 of 4 July 2023 (application from 20 January 2027)
- Directive 2006/42/EC (Machinery Directive) — EUR-Lex
- 9th ProdSV (German transposition of Directive 2006/42/EC) — gesetze-im-internet.de
- BGHM (German employers’ liability insurance): FAQ on the EU Machinery Regulation
- European Commission: Machinery — legal framework, harmonised standards, guidance
The regulation or standard itself is authoritative. This page is an expert summary, not legal advice.
Keep reading
More chapters of this guide
Machinery Regulation: Deadlines and Transition until 20 January 2027
A hard cut-off date instead of a transition period: from 20 January 2027, every placing on the market is governed exclusively by the Machinery Regulation.
Digital Operating Instructions under the Machinery Regulation: What Is Permitted
Paper is no longer mandatory: Article 10(7) permits digital operating instructions — subject to four conditions.
Technical Documentation under the Machinery Regulation: Scope, Retention, Access
From risk assessment to declaration of conformity: what must remain deliverable for 10 years — and what may stay protected.
QR Code on the Machine: How It Satisfies the Machinery Regulation
The Machinery Regulation does not prescribe a QR code — but it does require a permanent digital access route. The code is the de facto standard.
Declaration of Conformity under the Machinery Regulation: What Changes on 20 January 2027
The legally binding document behind the CE marking: what belongs in it — and what changes on 20 January 2027.
Risk Assessment under the Machinery Regulation: Obligation, Process, Documentation
No CE marking without a risk assessment: the process according to ISO 12100 — and the new Machinery Regulation requirements from cybersecurity to AI.
Substantial Modification of Machinery under the Machinery Regulation: Definition, Consequences, Obligations
Defined by law for the first time: Art. 3(16) says when a modification is substantial, and Art. 18 what follows.
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