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Directive 2006/42/EC → Regulation (EU) 2023/1230: the article-by-article comparison

Updated on 26 August 2026 · each row cites its source

Moving from the Machinery Directive to Regulation (EU) 2023/1230 is not a version update. It is a change of legal nature, and it produces three effects that nothing, at a cursory reading, reveals.

First effect: there is no longer any transposition. A directive sets a result and leaves each Member State to draft its law; 2006/42/EC had to be transposed by 29 June 2008 at the latest and applied from 29 December 2009 (art. 26). Twenty-seven transpositions, twenty-seven sets of cross-references, and technical files citing a national decree instead of a European article. The Regulation, on the other hand, concludes with an inescapable sentence: «This Regulation shall be binding in its entirety and directly applicable in all Member States» (art. 54, last paragraph). The enforceable text becomes the Regulation itself, in its consolidated version, and a technical file that relies on a national transposition text will, from 20 January 2027, rest on a basis devoid of purpose for new placings on the market.

Second effect: there is no transitional period. No coexistence window, no “until design stocks are exhausted”. The date of placing on the market decides, product by product. A machine placed on the market on 19 January 2027 is governed by the Directive; the same machine, on the 20th, by the Regulation. What Article 52 arranges is not a transition for manufacturers, but the protection of products already placed: products placed on the market in conformity with the Directive before that date may continue to be made available.

Third effect: the text has already begun to apply. Chapter VI, covering market surveillance, has applied since 19 July 2023 to products subject to the Directive, instead of Article 11 thereof (art. 52(1)). In other words: the 2027 deadline affects design and documentation; the enforcement regime, however, is already that of the Regulation.

The date, and the trap that accompanies it

20 January 2027, not the 14th.

The Regulation was published in OJ L 165 of 29 June 2023 and entered into force on 19 July 2023. The text published at the time stated «14 January 2027» in its Articles 51, 52 and 54. The corrigendum published in OJ L 169 of 4 July 2023, page 35, replaces that date with 20 January 2027 (points 5, 6 and 10) and corrects eleven other dates in the text along the way.

The trap is concrete: the HTML version of the original text, the one returned by EUR-Lex for CELEX document 32023R1230, still shows «14 January 2027», verified on 26 August 2026. Only the consolidated version incorporates the corrigendum, marked with the ►C1 tags. A file, a contract or a workload schedule built on the uncorrected version is off by six days, in a place where the error remains invisible.

Sources: Regulation (EU) 2023/1230, arts. 51, 52 and 54 — text published in OJ L 165 of 29.6.2023 · corrigendum, OJ L 169 of 4.7.2023, p. 35 · consolidated text as of 27.07.2026. Two other corrigenda exist, with no effect on the Spanish version: R(02) only affects the Dutch version; R(03) affects the German and Slovak versions.

What changes, row by row

Thirty topics, each referencing the article or annex governing it. The right-hand column is not a commentary: it represents what the row costs, in workload, to whoever manages the file.

Directive 2006/42/EC and Regulation (EU) 2023/1230: article-by-article comparison, verified on 26.08.2026
TopicUnder Directive 2006/42/ECUnder Regulation (EU) 2023/1230Practical implications
Legal nature of the text Directive: transposed by each Member State. Transposition by 29.06.2008 at the latest, application of national provisions from 29.12.2009 (art. 26). Regulation: «binding in its entirety and directly applicable in all Member States» (art. 54, last paragraph). No transposition. The reference text for the file becomes the Regulation itself. Cross-references to a national transposition act become without purpose for placings on the market after 20.01.2027.
Changeover date Repealed with effect from 20.01.2027 (Art. 51(2) of the Regulation, as corrected). Applicable from 20.01.2027 (Art. 54, second paragraph, as corrected). Entry into force: 19.07.2023. No transitional period. It is the date of placing on the market of the product, and not the order or design date, that determines the applicable text.
Products already on the market — Art. 52(1): products placed on the market in conformity with the Directive before 20.01.2027 may continue to be made available on the market. Art. 52(2): EC type-examination certificates issued and approval decisions adopted in accordance with Art. 12 of the Directive remain valid until their expiry. Compliant stock is sold without redoing the file. But Chapter VI of the Regulation already applies to these products since 19.07.2023, replacing Art. 11 of the Directive.
Scope and "related products" Art. 1(1): seven families of "products": machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices, partly completed machinery. Art. 2(1): machinery and five categories of related products (points (a) to (e)); partly completed machinery is also subject to the Regulation. The whole group is referred to as "products within the scope of this Regulation". Note: Article 3 does not define related products; the perimeter is established by enumeration in Article 2(1). The material scope changes little; the vocabulary changes everywhere. Almost all requirements now state "machinery or related product": a file drafted with only the word "machinery" must be reviewed sentence by sentence. And to know what a related product is, you must read Article 2, not the glossary in Article 3.
Definition of machinery, and software Art. 2, point (a): five indents, all physical. The safety component (point (c)) is a "component", with no mention of digital elements. Art. 3, point 1: six points, including (f): "an assembly […] missing only the uploading of the software intended for the specific application foreseen by the manufacturer". The safety component becomes "a physical or digital component, including software" (Art. 3, point 3). Safety software placed separately on the market is a regulated product in its own right, with its own technical documentation, declaration and, if it is self-evolving, its own notified body.
Partly completed machinery Art. 13. Assembly instructions: Annex VI. Declaration of incorporation: Annex II, Part 1, Section B. Relevant technical documentation: Annex VII, Part B, kept for ten years after the last date of manufacture. Arts. 11 and 22. Assembly instructions: Annex XI. EU declaration of incorporation: Annex V, Part B, which "continuously updated" (Art. 22(2)). Technical documentation: Annex IV, Part B, kept for ten years after placing on the market (Art. 11(3)). All references to annexes change, as does the starting point for the retention period. A declaration of incorporation template reused as-is will be formally incorrect.
Categories with enhanced assessment Annex IV: a single list of 23 categories, referred to in Art. 12(3) and (4). Annex I divided in two: Part A (6 categories) and Part B (19), Art. 6. The Commission may amend it by delegated acts (Art. 6(2)), based on risk criteria set out in paragraphs 4 to 7. First question of any file: Part A, Part B or outside Annex I? The answer determines the procedure, the schedule and the involvement of a notified body.
Machine learning in Annex I — Annex I, Part A, points 5 and 6: safety components "with fully or partially self-evolving behaviour" using machine learning approaches ensuring safety functions; machinery having embedded systems that do so without having been placed independently on the market. A safety function that learns moves the product into Part A, which means the mandatory intervention of a notified body, with no exit route via standards.
Conformity assessment procedures Art. 12. Outside Annex IV → internal checks on manufacture (Annex VIII). Annex IV with harmonised standards covering all relevant essential health and safety requirements → internal checks possible, or EC type-examination (IX), or full quality assurance (X). If not → IX or X. Art. 25. Outside Annex I → Module A, internal production control (Annex VI). Annex I Part B → Module A only if the design follows the harmonised standards or common specifications specific to the category covering all relevant essential health and safety requirements; otherwise, B+C (VII+VIII), H (IX) or G (X). Annex I Part A → solely B+C, H or G. The most costly break introduced by the text: for the six categories in Part A, self-certification disappears, even with fully applied harmonised standards.
Harmonised standards and presumption Art. 7(2): presumption for machinery manufactured in conformity with a harmonised standard the reference of which has been published in the OJEU. Citations compiled today in Implementing Decision (EU) 2023/1586, amended six times, most recently by Decision (EU) 2026/546 of 12.03.2026. Art. 20(1): the same mechanism, but under the Regulation. As of 26.08.2026, no standard is cited under it. Art. 20(3): the Commission may adopt common specifications by implementing acts if standardisation does not deliver. Each standard in the file carries two dated statuses: one under the Directive and one under the Regulation. A list of standards with a single status is obsolete in advance. No citation
Presumption via cybersecurity certification — Art. 20(9): products certified, or covered by a declaration of conformity, under a cybersecurity certification scheme adopted in accordance with Regulation (EU) 2019/881 and the references of which have been published in the OJEU are presumed to conform with points 1.1.9 and 1.2.1 of Annex III, in so far as those requirements are covered. A new route of proof, which will only exist once a scheme is published. It must be monitored in exactly the same way as standard citations. To be monitored
High-risk artificial intelligence — Art. 8, paragraphs added by Regulation (EU) 2026/1744 of 08.07.2026, applicable on 27.07.2026: the Commission adopts delegated acts amending Annex III to add requirements reflecting Regulation (EU) 2024/1689, applicable at the latest on 02.08.2028. Art. 20(10): in the meantime, presumption via the harmonised standards referenced in Art. 40 of that Regulation. Annex III is not frozen: the AI component will enter it via delegated act. The repository of requirements must be versioned and dated, never printed once and for all.
Where the essential requirements are located Annex I, preceded by its "GENERAL PRINCIPLES". Annex III: Part A (definitions), Part B (general principles) and then six chapters. The correlation table is in Annex XII. Any reference to "Annex I, point 1.x" must be transcribed as "Annex III, section 1.x". Note: the correlation table operates at the level of chapters (Annex I, points 1.1.2 to 1.1.8 → Annex III, Chapter 1), not section by section. Detailed mapping must be reconstructed manually.
Cybersecurity: 1.1.9 No equivalent requirement. Annex III, 1.1.9 "protection against corruption": the connection of another device must not lead to a hazardous situation; hardware components and software or data critical for safety are protected against accidental or intentional corruption; the machinery collects evidence of any legitimate or illegitimate intervention on them; the installed software that is necessary for it to operate safely is identified and this information must be easily providable at all times in an easily accessible manner. An entire section of the technical documentation with no precedent: integrity, event logging, software inventory. It cannot be recovered from a 2006/42 file: it must be built.
Control systems and self-evolving behaviour: 1.2.1 Annex I, 1.2.1: safety and reliability of control systems against foreseeable failures, faults and constraints. Annex III, 1.2.1: the same baseline, extended to "reasonably foreseeable malicious attempts from third parties", with, for all control systems, a tracing log of interventions and versions of safety software uploaded (enabled for five years); for wholly or partially self-evolving behaviour or logic: actions limited to the defined task and movement zone, recording of data on the decision-making process (retention: one year), correction possible at all times. Two retention periods embedded in the product architecture, not in a filing cabinet: one year of decision-making data, five years of logs, available on a machine that may be off-grid.
Instructions manual and instructions for use: language and status Annex I, 1.7.4: each machine must be accompanied by an instructions manual in the official language or languages of the Member State. Mandatory statements "Original instructions" and "Translation of the original instructions" (1.7.4.1, points (a) and (b)). Art. 10(7), last subparagraph: instructions for use, safety information and the information set out in Annex III are provided "in a language which can be easily understood by users, as determined by the Member State concerned". Annex III, 1.7.4, refers back to Art. 10(7) and no longer includes the original instructions / translation pairing. The original / translation formalism disappears from the text. The required language continues to be determined by each Member State: it must be verified market by market, not once for the whole Union.
Digital instructions Not provided for: the instructions manual accompanies the machinery. Art. 10(7): instructions may be provided in digital format. The manufacturer indicates how to access them, on the product or, where not possible, on its packaging or in an accompanying document (a); provides them in a format allowing printing, downloading and saving, accessible even during a breakdown (b); keeps them accessible online during the expected lifetime and for at least ten years after placing on the market (c). Paper format free of charge within one month if requested at the time of purchase. For non-professional users, essential safety information is still provided on paper. Ten-year hosting is a corporate commitment, not a box to tick: stable URL, frozen versions, verifiable uptime, languages, and a paper dispatch procedure within one month.
Declaration of conformity EC declaration of conformity, Annex II, Part 1, Section A. The original is kept for at least ten years after the last date of manufacture. EU declaration of conformity, Art. 21 and Annex V, Part A. It "continuously updated" (Art. 21(2)) and is translated into the required languages. It accompanies the product or, alternatively, the instructions state the internet address or machine-readable code providing access to it; the digital version remains online for at least ten years (Art. 10(8)). A declaration signed once and archived is no longer sufficient: it is kept up to date, and its version published online remains binding throughout the product's life cycle.
CE marking Article 16 and Annex III of the Directive. Articles 23 and 24: visible, legible and indelible marking; on the packaging and in accompanying documents where the nature of the product does not allow it or does not justify it; followed by the identification number of the notified body under the procedures of Article 25(2)(a, b, c) and (3)(b, c, d). The rating plate changes as soon as the procedure changes. The six categories in Part A now mandate a notified body number on the product.
Identification of the product and manufacturer Annex I, 1.7.3 (marking of machinery). Article 10(5): designation of model, series or type, year of manufacture, batch or serial number. Article 10(6): name, registered trade name or registered trade mark, postal address and website, email address or other digital contact, with a single contact point, in a language easily understood by users and authorities. Digital contact details become mandatory on the rating plate or its substitute. A bouncing email address constitutes a formal non-compliance.
Technical documentation: content Annex VII, Part A ("technical file"): manufacturing file, drawings, diagrams, calculation notes, test reports, internal measures for series manufacturing. Annex IV, Part A: fifteen items, two of which are entirely new: (m) the source code or programming logic of the safety-related software, upon reasoned request from a national authority; (n) for sensor-fed, remotely controlled or autonomous products whose safety-related operations are controlled by sensor data, a description of the general characteristics, capabilities and limitations of the system, data, and development, testing and validation processes. It must be determined before sale how safety source code will be provided to an authority without exposing the rest, and datasets and validation campaigns for a sensor-based system must be documented.
Technical documentation: retention Annex VII, Part A, point 2: technical file made available to authorities for at least ten years following the date of manufacture or, in the case of series manufacture, the last unit produced. It does not have to be located within the territory of the Community or permanently exist in material form, but must be capable of being assembled. Article 10(3): technical documentation and EU declaration of conformity kept at the disposal of market surveillance authorities for at least ten years after the placing on the market or putting into service. The starting point of the ten-year period shifts from the workshop to the market. For a product kept in storage for two years before being sold, the obligation lasts two years longer than before.
Substantial modification Absent concept: the expression "substantial modification" does not appear in the Directive. The topic was addressed in application guides and national laws. Defined in Article 3, point 16: modification, by physical or digital means, after placing on the market, not foreseen by the manufacturer, affecting safety by creating a new hazard or increasing an existing risk. Article 18: the person who makes it is considered to be a manufacturer, subject to Article 10 and the procedure in Article 25. Non-professional users modifying their own product are excluded. Retrofitting moves out of non-binding guidelines and into the legal text. Every intervention requires a written assessment and a traceable conclusion: it is the assessment, not inaction, that protects.
Obligations of importers The word "importer" does not appear in the Directive. Article 13 (machinery and related products) and Article 14 (partly completed machinery): ensure that the procedure of Article 25 has been applied, that the documentation under Annex IV, Part A exists, that the CE marking is affixed and documents are attached, and that the manufacturer has complied with Article 10(5), (6) and (8); state their own contact details, including digital details (paragraph 3); ensure instructions are provided (paragraph 4); ensure conformity during storage and transport (paragraph 5); refrain from placing the product on the market in case of doubt (paragraph 2). The importer becomes a gatekeeper, with a duty to refuse. Their checks must leave a dated trace; otherwise, they never occurred.
Obligations of distributors The word "distributor" does not appear in the Directive. Article 15 (machinery and related products) and Article 16 (partly completed machinery): act with due care; before making available on the market, verify (a) the CE marking, (b) the EU declaration of conformity referred to in Article 10(8), (c) the instructions in the language determined by the Member State of marketing, (d) that the manufacturer and importer have complied with Article 10(5) and (6) and Article 13(3). Four straightforward but enforceable checks, and a duty to withhold. A reseller that does not document them assumes the risk in place of the manufacturer.
Stepping into the role of manufacturer — Article 17: an importer or distributor who places a product on the market under their name or trade mark, or who modifies it in a way that may affect its conformity, is considered to be a manufacturer and assumes the obligations of Articles 10 and 11. Private labelling comes at a regulatory price: full technical documentation, declaration, conformity assessment procedure and ten-year retention.
Traceability of economic operators — Article 19: upon request from authorities, identify any economic operator who has supplied them with a product and any economic operator to whom they have supplied one; keep that information for ten years after being supplied. A commercial record-keeping obligation tied to commercial management rather than the technical department. It survives personnel departures.
Market surveillance Article 4: Member States establish or designate competent authorities and define their duties. Article 11: safeguard clause. Chapter VI, Articles 43 to 46, articulated with Regulation (EU) 2019/1020: corrective measures required from an economic operator refer to its Article 16(3). National procedure, Union safeguard procedure, compliant products presenting a risk, formal non-compliance. Already applicable since 19.07.2023, even to products subject to the Directive (Article 52(1)) — just like Chapter V (notified bodies, Articles 26 to 42), applicable since 20.01.2024 (Article 54, point (a)). Safeguard procedures do not wait for 2027.
Emergency procedures — Chapter IVa, Articles 25a to 25f, inserted by Regulation (EU) 2024/2748 of 09.10.2024 and applicable from 29.05.2026: priority processing by notified bodies and temporary derogation from procedures requiring their intervention, for "crisis-relevant goods", solely during an internal market emergency mode activated under Regulation (EU) 2024/2747. A dormant regime, triggered only by a Commission implementing act. It is essential to understand it so as not to confuse it with permanent flexibility.
Penalties Article 23: national regime, effective, proportionate and dissuasive; notification to the Commission before 29.06.2008. Article 50: the same qualifiers, and penalties "may include criminal penalties for serious infringements". Member States notify their regime at the latest by 20.10.2026 (paragraph 2, as corrected); Article 50(1) applies from that same date (Article 54, point (b), as corrected). The penalty deadline precedes the technical deadline by three months. To date, we have not identified the national regime details applicable to the Regulation: to be checked as published, Member State by Member State.

All references to articles and annexes above are drawn from the consolidated text of Regulation (EU) 2023/1230 as of 27.07.2026 and the text of Directive 2006/42/EC (OJ L 157, 9.6.2006). Standards status: consolidated Implementing Decision (EU) 2023/1586, checked on 26.08.2026.

The five new developments that require real work

Out of thirty rows of differences, five genuinely demand engineering hours, architectural decisions, or a notified body budget. The others can be handled through drafting revisions. Here are the five, ranked by impact on cost.

Annex I, APROCEDURE

The end of self-certification for six categories

Under the Directive, an Annex IV machine could bypass a notified body: it was enough for it to be manufactured in conformity with harmonised standards covering all relevant essential requirements, making internal checks on manufacture sufficient (Article 12(3)(a)). The Regulation removes that option for the six categories in Annex I, Part A: removable mechanical transmission devices including their guards, vehicle servicing lifts, portable cartridge-actuated fixing and other impact machinery, and the two categories involving machine learning. For these, Article 25(2) offers only three routes, all requiring a notified body: EU type-examination followed by Module C, full quality assurance, or unit verification.

Planning impact: if one of your products falls under Part A, the bottleneck is not documentation but scheduling. You need to secure capacity with a notified body, and that capacity must be booked before the rest of European industry catches on. Part B, on the other hand, preserves the Directive's approach: Module A remains possible, but only if harmonised standards or common specifications specific to that category cover all relevant requirements—a point that warrants close scrutiny as long as no standard has been cited under the Regulation.

1.1.9 · 1.2.1CYBERSECURITY

IT security becomes machinery safety

This is an unprecedented requirement. Requirement 1.1.9, "protection against corruption", requires that connection to another device does not lead to hazardous situations, that hardware components and software or data critical for safety are protected against accidental or intentional corruption, that the machinery collects evidence of any legitimate or illegitimate intervention on those components, and that the installed software necessary for safe operation is identified and readily accessible at all times. Requirement 1.2.1 completes the framework on the control system side by explicitly mentioning "reasonably foreseeable malicious attempts from third parties".

None of this can be recovered with a note at the end of the file. What is needed is a chain of trust for updates, a tamper-resistant event log, an inventory of embedded software, and a written answer to a simple question: how do you prove, ten years later, that an intervention on safety software took place and who carried it out? Article 20(9) opens an elegant way out (presumption of conformity via a cybersecurity certification scheme under Regulation (EU) 2019/881), but it requires that this scheme be published in the Official Journal, which is not currently the case for machinery.

1.2.1SELF-EVOLVING

Self-evolving behaviour: bounded and recorded

The Regulation does not say "Artificial Intelligence" in Annex III: it says "its fully or partially self-evolving behaviour or logic", which is both broader and more operational. For such machinery, requirement 1.2.1 requires that it does not perform actions outside its defined task and movement zone, that data on the decision-making process be recorded and retained for one year, and that correction be possible at all times; it also requires for any control system that the recording of the versions of the safety software uploaded be enabled for five years. Annex III, Part B, adds that the risk assessment includes the foreseeable evolution of behaviour where the product is designed to operate with varying levels of autonomy.

These two time frames are architectural constraints: on-board storage capacity, rotation policy, third-party readable format, availability on an off-grid machine. They are decided when choosing the control units, not when reviewing the file. And the link with Part A of Annex I is direct: if the self-evolving logic ensures a safety function and is based on machine learning, the product falls under points 5 or 6 of that Part A and, consequently, mandatory notified body involvement. Finally, since 27 July 2026, Article 8 provides that the Commission shall supplement Annex III, by means of delegated acts, with requirements reflecting Regulation (EU) 2024/1689 on artificial intelligence, applicable by 2 August 2028 at the latest: the Annex III you work with today is not the Annex III you will work with in 2029.

Art. 10(7)INSTRUCTIONS

Digital instructions, and the ten-year commitment

Allowing instructions for use in digital format is widely presented as a simplification. Above all, it is a shift of burden: from the printer to the website manager. The conditions of Article 10(7) are cumulative: indicate on the product how to access the instructions, provide them in a format that the user can print, download and save in order to access them even during a breakdown, and keep them accessible online throughout the expected lifetime and for at least ten years after placing on the market. Added to this are two paper obligations that do not disappear: the paper version free of charge, within one month, for the user who requests it at the time of purchase; and essential safety information in paper format for machinery intended for non-professional users, or that can reasonably be used by them.

Ten years of hosting is longer than the life of most website redesigns. This entails stable URLs, frozen and timestamped versions, one language per market, and a paper dispatch procedure that meets the one-month deadline. The same logic applies to the EU declaration of conformity, which Article 10(8) allows to be replaced, in the instructions, by an internet address or a machine-readable code, with the same requirement of ten years online.

Art. 3(16) · Art. 18MODIFICATION

Substantial modification enters the text

The Directive does not contain the expression. The Regulation defines it in Article 3, point 16: a modification, by physical or digital means, after placing on the market or putting into service, which is not foreseen or planned by the manufacturer, affecting safety by creating a new hazard or increasing an existing risk, to the point of requiring the addition of guards or protective devices that necessitate modifying the existing safety control system, or the adoption of additional protective measures to ensure stability or mechanical strength. Article 18 draws the consequence: anyone who carries out such a modification shall be considered to be a manufacturer, must declare conformity of the product under their sole responsibility, and apply the conformity assessment procedure of Article 25.

It is the most underestimated risk in the text, because it falls not on machine builders but on system integrators, maintenance personnel, and plant operators who retrofit their machinery fleet. The Regulation does not require abstaining: it requires knowing. A written assessment for each intervention, concluding whether the modification is substantial or not, and retained: that is what distinguishes a defensible retrofit from an indefensible one. A non-professional user who modifies their own machine for their own use falls outside this regime; no one else does.

Sources: Regulation (EU) 2023/1230, Arts. 3, 8, 10, 18, 20 and 25, and Annexes I, III and IV, consolidated text of 27.07.2026; Regulation (EU) 2026/1744 of 08.07.2026 (OJ L, 24.07.2026) for the paragraphs added to Arts. 8 and 20.

What does not change

An anxious reading of the Regulation gives the impression that one must start from scratch. That is false, and stating it clearly saves as much time as listing the new features. The methodological foundation of machinery safety is maintained almost word for word, meaning that the heaviest part of a well-crafted 2006/42 technical file—the risk assessment—carries over.

01

The iterative risk assessment process

Annex III, Part B, takes up the method identically: determine the limits of the product, including reasonably foreseeable misuse; identify the hazards and hazardous situations; estimate the risks; evaluate them; and then eliminate or reduce them following the order of priority in section 1.1.2. It is the logic of EN ISO 12100, unchanged.

02

The hierarchy of protective measures

First design, then protection, finally information. The principles of safety integration in section 1.1.2 apply "in all cases", including to partly completed machinery, exactly as under the Directive.

03

The logic of guards

Fixed guards that can only be opened with tools, movable guards associated with an interlocking device, adjustable guards limiting access to the parts strictly necessary for the work: requirements 1.4.1 to 1.4.3 retain the structure and substance of Annex I of the Directive.

04

Self-certification for most machinery

Machinery that does not fall into any Annex I category continues to be assessed by internal production control, Module A of Annex VI (Art. 25(4)). This applies to the majority of industrial machines: the general rule has not changed.

05

The role of harmonised standards

The mechanism of presumption of conformity is identical in principle (Art. 20(1) vs. Art. 7(2) of the Directive). What changes is not the rule, but the status of the list: citations under the Regulation are yet to come.

06

The ten-year retention period

Ten years under the Directive, ten years under the Regulation. Only the starting point shifts, from the date of manufacture to placing on the market or putting into service (Art. 10(3)).

A rigorous 2006/42 technical file should not be discarded: it should be translated. An approximate one cannot be translated: it must be rebuilt, and the Regulation makes approximations all the more apparent.

Sources: Regulation (EU) 2023/1230, Annex III, Parts A and B, sections 1.1.2 and 1.4.1 to 1.4.3, and Arts. 20(1) and 25(4); Directive 2006/42/EC, Annex I, General Principles, and Art. 7(2).

Your 2006/42 technical file: what to reuse and what to redo

Part by part, here is what happens to an existing technical documentation file. Three statuses: what carries over as is, what must be reworked by updating cross-references or content, and what has no precedent and must be built.

Adapting a 2006/42/EC technical file to Regulation (EU) 2023/1230
File componentStatusWhat needs to be doneLegal basis
Risk assessment Carried over The iterative method remains identical. Check two additions: hazards associated with the foreseeable evolution of self-evolving behaviour, and interaction risks within an assembly of machinery arranged and controlled to function as an integral whole. Annex III, Part B, point 1
List of essential requirements and justifications To review Renumber from Annex I to Annex III and then re-read: the correlation table operates at chapter level, not section level. Add "or related product" where the product is self-evolving. Annex III · Annex XII
Drawings, diagrams, calculation notes Carried over Points (c) and (d) of Annex IV, Part A, require the same items as Annex VII of the Directive: design and manufacturing drawings, diagrams of components, sub-assemblies and circuits, and explanations necessary for understanding them. Annex IV, A, (c) and (d)
Test reports and results Carried over Points (g) and (o): reports and results of design calculations, tests, inspections and examinations, including those carried out on components and fittings. Simply verify that each test is linked to the Annex III requirement it covers. Annex IV, A, (g) and (o)
List of applied standards To redo The presumption of conformity does not survive the change of text: it attaches to standards cited in the OJEU under the Regulation, and none are as of 26.08.2026. Maintain a dated dual status per standard and monitor implementing decisions. Art. 20(1) · Annex IV, A, (e) and (f)
Instructions manual To review Content carries over in large part, but: remove the "Original instructions" / "Translation of the original instructions" formalism, which is no longer in the text; apply the language regime of Art. 10(7); add the EU declaration, or the internet address or machine-readable code providing access to it. Art. 10(7) · Annex III, 1.7.4
Declaration of conformity To redo New template, new name, new reference: EU declaration according to the model in Annex V, Part A, citing the Regulation and kept "continuously updated". If published online, ensure ten years of availability. Art. 21 · Annex V, A · Art. 10(8)
Marking and rating plate To review Check the identification markings of Art. 10(5), add the digital contact details of paragraph 6, and the notified body number if the chosen procedure falls under Art. 25(2) or paragraph 3, points (b), (c) or (d). Art. 10(5)-(6) · Art. 24
Partly completed machinery file To review Move technical documentation to Annex IV, Part B; assembly instructions to Annex XI; declaration of incorporation to Annex V, Part B, designated as the EU declaration of incorporation, continuously updated. Art. 11 · Art. 22 · Annexes IV, V, XI
Choice of conformity assessment procedure To review Reclassify the product: Part A, Part B or outside Annex I. Part A permanently rules out Module A; Part B only permits it if standards cover all relevant requirements. Art. 6 · Art. 25 · Annex I
Cybersecurity block To be created No precedent in a 2006/42 file. Protection of critical hardware and software, collection of intervention evidence, inventory of installed software, event logging and retention periods. Annex III, 1.1.9 and 1.2.1
Software elements and sensor-based systems To be created Provide for delivery, upon reasoned request from an authority, of the source code or programming logic of safety-related software; document capabilities, limitations, data, and development, testing, and validation processes for sensor-fed, remotely controlled, or autonomous products. Annex IV, A, (m) and (n) · Art. 10(3)
Retention management To review Shift the start of the ten-year period from the date of manufacture to placing on the market or putting into service, and set up a separate log for the traceability of economic operators, upstream and downstream. Art. 10(3) · Art. 19

Sources: Regulation (EU) 2023/1230, Arts. 6, 10, 11, 19, 20, 21, 22, 24 and 25, Annexes I, III, IV, V, XI and XII; Directive 2006/42/EC, Annexes I and VII. Review of 26.08.2026 based on the consolidated text.

Six questions, six answers with their sources

Does the Regulation apply from 14 or 20 January 2027?

From 20 January 2027. The text published in OJ L 165 of 29 June 2023 stated “14 January 2027” in Articles 51, 52 and 54; the corrigendum published in OJ L 169 of 4 July 2023, page 35 replaces that date with 20 January 2027 (points 5, 6 and 10). This pitfall is not merely theoretical: the uncorrected HTML version of the original text still displays “14 January” on EUR-Lex, verified on 26 August 2026, whereas the consolidated version incorporates the correction within ►C1 tags. In case of doubt, the consolidated version serves as a documentary reference, and the corrigendum has legal force.

Do files for machinery already sold need to be redone?

No. Article 52(1) provides that Member States shall not impede the making available on the market of products placed on the market in accordance with the Directive before 20 January 2027. Subject to two provisos, however. First: Chapter VI of the Regulation, governing market surveillance, has already applied to these products since 19 July 2023, replacing Article 11 of the Directive. Second: a substantial modification within the meaning of Article 3, point 16, turns its author into a manufacturer pursuant to Article 18, and the modified product then becomes subject to the Regulation.

Are my EC type-examination certificates still valid?

Article 52(2) provides that EC type-examination certificates issued and approval decisions adopted in accordance with Article 12 of the Directive “shall remain valid until they expire”. What the text does not state explicitly is whether such a certificate is sufficient to cover placing on the market after 20 January 2027, when the applicable procedure is already that of Article 25 and EU type-examination is governed by Annex VII to the Regulation. Point to be verified with the relevant notified body and, where appropriate, in the light of Commission guidelines: we make no assertion on this in the current state of the text.

Does a harmonised standard under 2006/42 confer a presumption of conformity under the Regulation?

Not automatically. Article 20(1) links the presumption to harmonised standards “the references of which have been published in the Official Journal of the European Union”, in accordance with the applicable act. As of 26 August 2026, no standard is cited under the Regulation; current citations are under the Directive, via Implementing Decision (EU) 2023/1586, which repealed Decision (EU) 2019/436 and has been amended six times, most recently by Decision (EU) 2026/546 of 12 March 2026. A first batch of citations under the Regulation is announced for late 2026, but that timeline stems from a private source, not the Commission: it must be treated as a working hypothesis, not a fixed date.

Can I continue to self-certify my machinery?

It depends entirely on Annex I. Outside Annex I, internal production control (Module A, Annex VI) remains the rule (Art. 25(4)), covering most industrial machinery. For Annex I, Part B, Module A is only possible if the product is designed in accordance with harmonised standards or common specifications specific to that category that cover all the relevant essential health and safety requirements; otherwise, an EU type-examination followed by Module C, full quality assurance, or unit verification is required. For Annex I, Part A (six categories), self-certification no longer exists, regardless of the standards applied.

Are paper instructions disappearing?

No: they are becoming conditional, which is not the same thing. Article 10(7) authorises a digital format if the manufacturer indicates how to access the instructions, provides them in a format that allows them to be printed, downloaded, and saved, ensures they are accessible even during a breakdown, and maintains them online for the expected lifetime and for at least ten years after placing on the market. Paper remains mandatory and free of charge, within one month, for any user who requests it at the time of purchase. And for machinery intended for non-professional users, or which can reasonably be expected to be used by them, safety information essential for putting into service and safe use must be provided in paper format without conditions.

Sources

Legal texts. Regulation (EU) 2023/1230 of 14 June 2023 on machinery, OJ L 165, 29.6.2023 — published text · consolidated text of 27.07.2026 (02023R1230) · corrigendum, OJ L 169, 4.7.2023, p. 35. Directive 2006/42/EC of 17 May 2006, OJ L 157, 9.6.2006 — full text.

Amending acts to the Regulation. Regulation (EU) 2024/2748 of 09.10.2024 (OJ L of 08.11.2024): insertion of Chapter IVa, emergency procedures, applicable 29.05.2026 · Regulation (EU) 2026/1744 of 08.07.2026 (OJ L of 24.07.2026): Art. 8 and Art. 20(10), artificial intelligence component, applicable 27.07.2026. Both appear at the beginning of the consolidated text (blocks ►M1 and ►M2).

Other cited acts. Regulation (EU) 2019/1020 on market surveillance, cited in Art. 43 · Regulation (EU) 2024/2747, governing the activation of emergency procedures · Regulation (EU) 2019/881, cited in Art. 20(9) · Regulation (EU) 2024/1689 on artificial intelligence, cited in Arts. 8 and 20(10).

Harmonised standards. Consolidated Implementing Decision (EU) 2023/1586 (02023D1586-20260515), which repealed Decision (EU) 2019/436, as last amended by Decision (EU) 2026/546 of 12.03.2026 · European Commission summary list. No citation under Regulation (EU) 2023/1230 found as of 26.08.2026.

Caveats. The rows of this comparison are taken directly from the cited texts; assessments of practical implications are our own analysis and do not bind the Union institutions. Three points remain marked as uncertain, and are noted as such in the body of the page: the exact scope of EC type-examination certificates after 20.01.2027, the content of national penalties regimes adopted pursuant to Article 50, and the timetable for the first citations of standards under the Regulation. The consolidated text is a documentation tool with no legal effect: for any decision, refer to the text published in the Official Journal and its corrigendum.