On 20 January 2027, Machinery Directive 2006/42/EC stops applying. Regulation (EU) 2023/1230 replaces it on the same day, with no period during which the two texts coexist. A machine placed on the market on 19 January falls under the Directive; the same machine placed on the market on the 20th falls under the Regulation.
This article sets out what changes, what does not, and what remains to be done before then.
The essentials in six points
- A regulation, no longer a directive. The text applies directly and identically in every Member State, with no national transposing law.
- A single date. 20 January 2027, with no overlap.
- Six categories of machinery can no longer be certified by the manufacturer alone: a notified body is always involved.
- Substantial modification enters the text: whoever transforms a machine in service may become its manufacturer.
- Software counts. Cybersecurity, machine learning and autonomous mobile machinery have their own requirements.
- Paper is no longer mandatory. Instructions and the declaration of conformity may be digital, under conditions.
From a directive to a regulation
Directive 2006/42/EC has applied since 29 December 2009. Like any directive, it set a result and left each State to write it into its own law. Hence differences in wording and interpretation from one country to the next.
A European regulation is not transposed. It is binding in its entirety and directly applicable. Regulation (EU) 2023/1230 was adopted on 14 June 2023 and published in the Official Journal of 29 June 2023.
The text also takes up the common architecture of European product legislation: the same definitions, the same roles for economic operators, the same conformity assessment modules as for low voltage or electromagnetic compatibility.
Along the way it repeals a second text, Directive 73/361/EEC on wire-ropes, chains and hooks.
The timeline
The dates in the text published on 29 June 2023 were miscalculated. A corrigendum of 4 July 2023 corrected them: read the 20th where the first publication said the 14th. The dates below are the corrected ones.
| Date | What applies |
|---|---|
| 19 July 2023 | Entry into force. Transitional provisions (Article 52) already applicable. |
| 20 January 2024 | Articles 26 to 42: notification of conformity assessment bodies. |
| 20 July 2024 | The Commission’s power to amend Annex I by delegated act. |
| 20 October 2026 | Article 50: Member States lay down their penalties. |
| 20 January 2027 | The Regulation applies. Directive 2006/42/EC is repealed. |
No overlap period
Until 19 January 2027, a manufacturer applies the Directive, and only the Directive. From the 20th, it applies the Regulation, and only the Regulation. The German bodies DGUV and KAN, like the European agricultural machinery association CEMA, all describe this switch as having no transition.
Two provisions soften the impact.
Machinery already on the market remains compliant. Article 52 forbids Member States from impeding the making available of a product placed on the market under the Directive before 20 January 2027. An existing fleet does not need recertifying.
EC type-examination certificates remain valid until they expire.
And one practice is accepted by the Commission: before 20 January 2027, a declaration of conformity drawn up under the Directive may state that the machine also meets the Regulation, where that is the case. It is the clean way to prepare a series that will be sold on both sides of the date.
Who is concerned, and for which products
The scope remains that of the Directive, with a reorganised vocabulary:
- machinery;
- related products: interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices;
- partly completed machinery.
One clarification carries weight: a safety component can now be digital. Software that performs a safety function and is placed on the market on its own is a product subject to the Regulation.
The Regulation sets the obligations of each operator, article by article.
| Operator | Articles | Central obligation |
|---|---|---|
| Manufacturer | 10 | Design to Annex III, compile the technical documentation, assess conformity, declare, affix the CE marking. Keep the documentation and the declaration for at least ten years. |
| Manufacturer of partly completed machinery | 11 | Technical documentation, declaration of incorporation, assembly instructions. |
| Authorised representative | 12 | Act within the limits of its written mandate. |
| Importer | 13 and 14 | Place only compliant products on the market, check the documentation, add its contact details, keep the declaration for ten years. |
| Distributor | 15 and 16 | Check the CE marking, the declaration, the instructions and the contact details before selling. |
Article 17 adds a rule worth knowing. An importer or distributor that sells under its own name, or modifies the product in a way that may affect its compliance, takes on the manufacturer’s obligations.
High-risk machinery: Annex I
The Directive listed twenty-three categories in its Annex IV. The Regulation takes them over in its Annex I, adds two, and splits the list into two parts.
Part A: a notified body, always
For six categories, the manufacturer can no longer self-certify, even when it applies harmonised standards in full.
- Removable mechanical transmission devices, including their guards.
- Guards for removable mechanical transmission devices.
- Vehicle servicing lifts.
- Portable cartridge-operated fixing and other impact machinery.
- Safety components with fully or partially self-evolving behaviour using machine learning approaches, ensuring safety functions.
- Machinery that embeds such systems, in respect of those systems only.
The first four come from the old Annex IV. The last two are new.
Part B: self-certification remains possible, on one condition
Nineteen categories. They include circular saws and band-saws, surface planers and vertical spindle moulders, manually loaded metal presses and injection moulding machines, manually loaded household refuse trucks, devices for lifting persons with a fall hazard of more than three metres, protective devices that detect the presence of persons, logic units ensuring safety functions, and roll-over and falling-object protective structures.
Which procedure for which product
Article 25 sets the possible routes.
| Product | Permitted procedures |
|---|---|
| Annex I, Part A | EU type-examination followed by conformity to type (modules B and C), or full quality assurance (module H), or unit verification (module G). |
| Annex I, Part B | Internal production control (module A), only if the machine is designed in accordance with harmonised standards or common specifications covering all the applicable requirements. Otherwise: modules B and C, H or G. |
| All other machinery | Internal production control (module A). |
The modules are described in Annexes VI to X. The Commission can move a category from one part to the other by delegated act: the list is not fixed.
Substantial modification
The Directive said nothing about a machine transformed after being put into service. Each country had its own doctrine. The Regulation gives a definition, in Article 3, point 16.
A modification is substantial when it meets all of these conditions:
- it is made by physical or digital means, after the placing on the market or putting into service;
- it was not foreseen by the manufacturer;
- it affects safety, by creating a new hazard or increasing an existing risk;
- it requires either the addition of guards or protective devices that make it necessary to modify the safety control system, or additional protective measures for stability or mechanical strength.
The consequence is in Article 18. Whoever carries out a substantial modification becomes a manufacturer. They bear the obligations of Article 10, carry out the conformity assessment and draw up the declaration under their own responsibility.
One exception: a non-professional user who modifies a machine for their own use.
For an operator, the question arises with every modernisation project. A cycle rate raised by a program update, a station added to a line, a fixed guard replaced by a light curtain: none of these cases is settled in advance by the text. Each is judged against the four conditions, and the analysis must be written down and kept.
The word “digital” matters. A purely software modification may be enough.
Software, cybersecurity, machine learning
The essential health and safety requirements move from Annex I of the Directive to Annex III of the Regulation. The structure is kept. The additions cover what the 2006 Directive could not foresee.
Protection against corruption (section 1.1.9). The software and data on which compliance depends must be identified and protected against accidental or intentional corruption. The machine must keep evidence of interventions in its software or configuration.
Control systems (section 1.2.1). They must withstand reasonably foreseeable malicious attempts by third parties, where these could lead to a hazardous situation. Functional safety and cybersecurity meet in a text on placing products on the market.
Self-evolving behaviour. A machine whose logic evolves must not act beyond its defined task and movement space.
Records. Two retention periods are set:
| What is recorded | Period |
|---|---|
| Data on the safety decisions taken by software | One year |
| Log of interventions and of the safety software versions uploaded | Five years after the upload |
These records serve to demonstrate conformity, on a reasoned request from a national authority.
Autonomous mobile machinery (chapter 3). It must have a supervisory function specific to the autonomous mode. The supervisor may only, remotely, stop the machine, start it or move it to a safe position.
Technical documentation (Annex IV). On a reasoned request from an authority, the manufacturer provides the source code or programming logic of the safety-related software. For machinery that is sensor-fed, remotely driven or autonomous, the documentation describes the capabilities and limitations of the system, and its development, testing and validation.
Documentation goes digital
This is the most visible change for the workshop and for the customer.
The instructions
Article 10(7) allows the manufacturer to provide the instructions in digital form. Four conditions:
- The way to access them is marked on the machine or, failing that, on its packaging or an accompanying document.
- The user can download them, save them and print them.
- They remain accessible online for the expected lifetime of the machine, and for at least ten years after the placing on the market.
- If the purchaser asks at the time of purchase, the paper version is provided free of charge, within one month.
One limit: for machinery intended for non-professional users, or that they can reasonably be expected to use, the essential safety information must still be provided on paper.
The declaration of conformity
It can accompany the machine, or be replaced by an internet address or a machine-readable code leading to it. If it is digital, the same rule applies: accessible online for the expected lifetime, and for at least ten years.
Partly completed machinery
The assembly instructions can also be digital.
Ten years online is a commitment on hosting, naming and archiving. It needs preparing: an address that changes, a provider that disappears, and the condition is no longer met.
Harmonised standards: where things stand
Applying a harmonised standard remains voluntary. But it is the standard that gives the presumption of conformity, and it is the standard that opens self-certification for Part B of Annex I.
A standard only gives that presumption once its reference is published in the Official Journal under the Regulation. A standard cited under the Directive counts only for the Directive.
The state of the work:
- On 20 January 2025, the Commission sent CEN and CENELEC a standardisation request, through Implementing Decision C(2025) 129. It covers the revision of existing standards and the drafting of new ones.
- The first deadline, for priority standards, was set for 20 January 2026.
- In early 2026, a first batch had been submitted to the Commission for review.
As of 9 October 2026, we found no list of harmonised standards published in the Official Journal under the Regulation. Before basing a declaration on a standard, check the Commission’s machinery page.
Two other instruments exist. Where there is no harmonised standard, the Commission can adopt common specifications (Article 20), which give the same presumption. And a guide to application of the Regulation is being drafted; its publication was announced for 2026 and we could not confirm it.
What does not change
The foundation stays in place.
- Risk assessment remains the starting point of design.
- The manufacturer remains responsible for compliance, the technical documentation, the declaration and the CE marking.
- Most of the 2006 essential requirements are carried over as they stand.
- The great majority of machinery, outside Annex I, remains under self-certification by internal production control.
- The Regulation covers the placing on the market. The safety of machinery in service still falls under each country’s occupational health and safety rules.
How it fits with other texts
A machine that is connected or uses artificial intelligence falls under several regulations at once.
| Text | What it adds | Dates |
|---|---|---|
| AI Act, (EU) 2024/1689 | Machinery legislation is listed in its Annex I. An AI system that is a safety component subject to third-party assessment is high-risk. | Obligations postponed to 2 August 2028 for these products. |
| Cyber Resilience Act, (EU) 2024/2847 | Cybersecurity requirements for products with digital elements, over their whole life cycle. | Vulnerability reporting since 11 September 2026; main obligations on 11 December 2027. |
The so-called “Digital Omnibus” regulation, (EU) 2026/1744, in force since 27 July 2026, also amends the Machinery Regulation. Work from the consolidated version published by EUR-Lex, not from the 2023 text.
And in Switzerland
Switzerland takes over European machinery law through its Machinery Ordinance (MaschV, OMach). A total revision was put out to consultation from 19 September to 19 December 2025. It aims to take over the Regulation by reference, with no substantive divergence, and on the same date as the Union: 20 January 2027.
What is at stake is the mutual recognition agreement between Switzerland and the Union. It can only be updated if the two bodies of law are equivalent.
We found no confirmation of final adoption by the Federal Council. A Swiss manufacturer exporting to the Union must in any case apply the Regulation from 20 January 2027.
Action plan before 20 January 2027
- Classify each product: machinery, related product, partly completed machinery, or out of scope.
- Check for each one whether it appears in Annex I, and in which part.
- For Part A, get in the queue with a notified body: lead times will lengthen as the date approaches.
- Reread the risk assessment against the new sections of Annex III: corruption, attacks, self-evolving behaviour.
- List the safety software, its versions, and the means of tracing interventions in it.
- Update the technical documentation template to Annex IV.
- Redo the templates for the declaration of conformity and the declaration of incorporation to Annex V.
- Decide on the format of the instructions and, if they go digital, guarantee ten years online.
- Identify stock: a machine built in 2026 and placed on the market after 20 January 2027 falls under the Regulation.
- Write the internal procedure for analysing modifications to machinery in service.
Seven pitfalls
- Waiting for a transition period. There is none.
- Confusing manufacture with placing on the market. It is the date each unit is placed on the market that counts.
- Relying on a standard cited for the Directive. It does not give the presumption of conformity with the Regulation.
- Believing the existing fleet is affected. A machine in service before the date does not need recertifying, as long as it is not substantially modified.
- Forgetting software. An update can be a substantial modification; safety software sold on its own is a product.
- Reading the 2023 text without the corrigendum. Every date on the 14th is wrong.
- Moving to digital instructions without an archiving plan. The ten-year obligation outlives a change of provider.
Sources
- Regulation (EU) 2023/1230, official text on EUR-Lex — Articles 3, 10, 11, 17, 18, 20, 25, 50 to 54; Annexes I, III, IV, V.
- European Commission, machinery page — status of standards and guidance documents.
- DGUV, Regulation (EU) 2023/1230 — no transitional phase.
- KAN, the Machinery Regulation and harmonised standards.
- BAuA, The new European Machinery Regulation.
- SECO, Machinery (in German) and consultation file 2025/44 on Fedlex for the revision of the Machinery Ordinance.
This article is an information summary. It replaces neither a reading of the official text nor the opinion of a notified body on a given product.
Going further
- Functional safety of machinery: IEC 62061 and ISO 13849
- ISO 13849, IEC 62061 and IEC 60204-1
- IEC 62443, security of industrial systems
- Digital instructions: the four conditions, in brief
- Document digitization: from paper drawings to documents you can question
20 January 2027 is not one more administrative deadline. It is the day the machine, its software and its documentation come under a single text. Those who have classified their products and redone their templates before the end of 2026 will see nothing more than a change of reference on the declaration.