Machinery Regulation vs Machinery Directive: What Changes

Machinery Regulation vs Machinery Directive: every change from 20 January 2027 side by side, with the article and annex references of both acts.

Directive 2006/42/EC applies until 19 January 2027 through national transposition, and Article 51(2) of the Regulation repeals it with effect from the next day. No parallel period follows, so every product placed on the market or put into service from then on must meet the EU Machinery Regulation.

The table sets 15 topics side by side, in the order of the sections below.

Topic	Directive 2006/42/EC	Regulation (EU) 2023/1230	Detail page
Legal form	Directive, transposed by 29 June 2008 (Art. 26(1))	Regulation, directly applicable (Art. 54)	Regulation (EU) 2023/1230 full text
Products placed on the market	Until 19 January 2027	From 20 January 2027	Machinery Regulation timeline
Product categories	Seven, Art. 1(1)(a) to (g)	Seven, Art. 2(1)	scope of the Machinery Regulation
Exclusions	12, Art. 1(2)(a) to (l)	17, Art. 2(2)(a) to (q)	Machinery Regulation exclusions
Definitions	Art. 2, points (a) to (l) as adopted	Art. 3, 38 points	Machinery Regulation definitions
High-risk list	Annex IV, 23 points	Annex I, Part A 6 and Part B 19	high-risk machinery categories of Annex I
Essential requirements	Annex I	Annex III	essential health and safety requirements
Conformity modules	Annex VIII internal checks; Annex IX with Annex VIII point 3; Annex X	Modules A, B, C, H and G in Annexes VI to X	conformity assessment under the Machinery Regulation
Safety components list	Annex V, 17 points	Annex II, 20 points	safety components and Annex II
Technical documentation	Annex VII; at least 10 years from manufacture or the last unit	Annex IV; at least 10 years after placing on the market or putting into service	machinery technical file
Instructions	Annex I, section 1.7.4; 22 content points	Art. 10(7), digital format allowed; 24 content points	machinery instructions and the digital format rules
Economic operators	Two defined	Four defined; duties in Arts 10 to 19	obligations of economic operators under the Machinery Regulation
Substantial modification	Not defined	Art. 3(16); Art. 18	substantial modification of machinery
Harmonised standards	Implementing Decision (EU) 2023/1586, repealed with effect from 20 January 2027	None cited in the Official Journal as of 12 November 2026	harmonised standards for machinery
Penalties	Art. 23	Art. 50(1), may include criminal penalties; applies since 20 October 2026	market surveillance of machinery

From a Directive to a Directly Applicable Regulation

A directive binds Member States to a result and needed national transposition, while Regulation (EU) 2023/1230 is binding in its entirety and directly applicable in all Member States under the last sentence of its Article 54. Directive 2006/42/EC had to be transposed by 29 June 2008 and applied from 29 December 2009 (Article 26(1)).

The Regulation entered into force on 19 July 2023 and applies from 20 January 2027, as corrected by the corrigendum in OJ L 169, 4.7.2023, p. 35.

Two parts apply early. Articles 26 to 42 on notified bodies have applied since 20 January 2024, and Article 50(1) since 20 October 2026: national penalties must be "effective, proportionate and dissuasive", may include criminal penalties and have no EU fine amount.

Article 23 of the Directive did not mention criminal penalties. The early dates are listed with the Regulation (EU) 2023/1230 full text.

No Parallel Period: Articles 51 and 52

Article 51(2) of Regulation (EU) 2023/1230 repeals Directive 2006/42/EC with effect from 20 January 2027, and references to the Directive are read as references to the Regulation through the Annex XII correlation table. Article 51(1) also repeals Directive 73/361/EEC.

Products placed on the market under the Directive before that date may still be made available (Article 52(1)); every product placed on the market or put into service later must meet the Regulation. Chapter VI, on market surveillance, has applied to those Directive products since 19 July 2023, instead of Article 11 of the Directive.

The Commission's machinery page adds that machinery placed on the market before that date must comply with the Directive, and that its declaration may also state conformity with the Regulation, if applicable. Every date is in the Machinery Regulation timeline.

Annex XII: Where Each Directive Provision Went

Annex XII of Regulation (EU) 2023/1230 is the correlation table: it maps Articles 1 to 29 of Directive 2006/42/EC, including Article 21a, and its Annexes I to XI to their place in the Regulation.

Three renumberings change what an annex number means: Directive Annex I (essential requirements) is now Annex III, Directive Annex IV (high-risk categories) is now Annex I, and Directive Annex VII (technical file) is now Annex IV, as the consolidated text shows.

Machinery Directive 2006/42/EC	Regulation (EU) 2023/1230	Subject
Art. 1	Art. 2	Scope
Art. 2	Art. 3	Definitions
Art. 3	Art. 9	Specific Union legislation
Art. 4(1), (2)	Art. 8	Market surveillance (Directive); essential health and safety requirements (Regulation)
Art. 5	Arts 10 and 11	Obligations of manufacturers
Art. 6	Art. 4	Free movement
Art. 7	Art. 20(1)	Presumption of conformity
Art. 8(1)	Arts 6(1) and 7(1)	High-risk categories and safety components
Art. 10	Art. 44(3)	Disputing a harmonised standard
Art. 11	Arts 43, 44 and 45	Safeguard and market surveillance procedures
Art. 12	Art. 25	Conformity assessment procedures
Art. 13	Art. 11	Partly completed machinery
Art. 14 and Annex XI	Arts 26 to 42 (Annex XI to Art. 30)	Notified bodies
Art. 15	Art. 5	Installation and use
Art. 16	Arts 23 and 24	CE marking
Art. 17	Art. 46	Formal non-compliance
Art. 18	Art. 49	Confidentiality
Art. 21	Art. 53	Dissemination of information (Directive); evaluation and review (Regulation)
Art. 21a	Art. 47	Exercise of the delegation
Art. 22	Art. 48	Committee procedure
Art. 23	Art. 50	Penalties
Art. 25	Art. 51	Repeal
Art. 28	Art. 54, first paragraph	Entry into force
Art. 29	Art. 54, second and third paragraphs	Addressees (Directive); application (Regulation)
Annex I, general principles and section 1.1.1	Annex III, Parts A and B	Definitions and general principles
Annex I, sections 1.1.2 to 6	Annex III, chapters 1 to 6	Essential health and safety requirements
Annex II, A and B	Annex V, Parts A and B	Declarations
Annex IV	Annex I	High-risk categories
Annex V	Annex II	Indicative list of safety components
Annex VI	Annex XI	Assembly instructions for partly completed machinery
Annex VII, A and B	Annex IV, Parts A and B	Technical documentation
Annex VIII (Art. 12(3)(a))	Annex VI	Internal production control (module A)
Annex VIII, point 3 (Art. 12(3)(b))	Annex VIII	Conformity to type (module C)
Annex IX	Annex VII	Type-examination (module B)
Annex X	Annex IX	Full quality assurance (module H)
None	Annex X	Unit verification (module G)

Directive Provisions Without a Counterpart

Annex XII gives no Regulation counterpart for Articles 4(3) and (4), 8(2), 9, 19, 20, 24, 26 and 27 of Directive 2006/42/EC, nor for its Annex III on the CE marking, whose rules now sit in Articles 23 and 24 of the Regulation.

Conversely, Articles 13 to 19 and 52 and Annex X of the Regulation have no Directive counterpart, and Article 12 matches only the definition in Directive Article 2(j).

High-Risk Categories: Annex IV of the Directive vs Annex I of the Regulation

Annex I of Regulation (EU) 2023/1230 replaces the 23 points of Annex IV of Directive 2006/42/EC with 25 categories: six in Part A and 19 in Part B. Directive points 14, 15, 16 and 18 became Part A points 1 to 4: removable mechanical transmission devices including their guards, guards for such devices, vehicle servicing lifts, and portable cartridge-operated fixing and other impact machinery.

Part A points 5 and 6 are new: safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions, and machinery with such embedded systems. Each point is described under high-risk machinery categories of Annex I.

Article 6(2) lets the Commission add, withdraw or move categories by delegated act; as of 12 November 2026, no such act exists and Annex I is unchanged since adoption.

The notification counts below come from NANDO, as of 12 November 2026.

Aspect	Directive 2006/42/EC	Regulation (EU) 2023/1230
Count	Annex IV, 23 points	Annex I, Part A 6 and Part B 19
Moved to Part A	Annex IV points 14, 15, 16 and 18	Part A points 1 to 4
New categories	None	Part A points 5 and 6
Routes for listed products	Art. 12(3): Annex VIII, Annex IX with Annex VIII point 3, or Annex X, with harmonised standards covering all relevant requirements; Art. 12(4): Annex IX with Annex VIII point 3, or Annex X	Part A: B+C, H or G (Art. 25(2)); Part B: module A under the Art. 25(3) condition, otherwise B+C, H or G
Unit verification	Not available	Module G, Annex X (unit verification (module G))
Type-examination certificate	EC certificate, validity reviewed every five years (Annex IX, point 9.3)	EU certificate valid for at most five years (Annex VII, point 6.1) (EU type-examination (module B))
Active NANDO notifications, as of 12 November 2026	79	36 (notified bodies for machinery)

Conformity Routes and the New Module G

Under Article 12 of Directive 2006/42/EC, machinery not in Annex IV used internal checks (Annex VIII), and Annex IV machinery built to harmonised standards covering all relevant requirements could also use them, while other Annex IV machinery needed EC type-examination or full quality assurance.

Under Article 25 of Regulation (EU) 2023/1230, Part A products always use module B with C, module H or module G (Article 25(2)).

Part B products use module A only with harmonised standards or common specifications specific to that category covering all relevant essential requirements, otherwise the same three routes (Article 25(3)). All other products use module A (Article 25(4)). The four categories moved into Part A therefore lose internal checks.

Module G, unit verification under Annex X, has no Directive counterpart, and the notified body number follows the CE marking (Annex X, points 4 and 5.1). The modules sit in Annexes VI (A), VII (B), VIII (C), IX (H) and X (G), as set out under conformity assessment under the Machinery Regulation.

Software, Cybersecurity and Self-Evolving Behaviour

Regulation (EU) 2023/1230 defines a safety component as a physical or digital component, including software (Article 3(3)), where Article 2(c) of Directive 2006/42/EC did not mention software. The Commission's Directive Guide, Edition 2.3 (April 2024), treats independently placed software as no safety component.

Annex II of the Regulation lists 20 points against 17 in Directive Annex V; new are point 18, software ensuring safety functions, point 19, self-evolving machine-learning safety components, and point 20, cabin filtration systems.

Annex III, section 1.1.9, protection against corruption, has no Directive equivalent. Section 1.2.1(a) adds reasonably foreseeable malicious attempts, which section 1.2.1 of the Directive did not mention, and 1.2.1(f) requires a tracing log enabled for five years after the upload of safety software.

Article 20(9) presumes conformity with both sections for products certified under a scheme of Regulation (EU) 2019/881 whose references are published in the Official Journal.

Self-evolving behaviour is not defined in Article 3 (recital 55); products under Annex I, Part A, points 5 and 6 follow the Article 25(2) routes, and their safety decision data is retained for one year (section 1.2.1, second subparagraph, point (b)).

AI systems acting as safety components are also high-risk under Regulation (EU) 2024/1689. Design rules are set out under machinery with self-evolving behaviour.

Topic	Directive 2006/42/EC	Regulation (EU) 2023/1230	Detail page
Safety component	Art. 2(c), no mention of software	Art. 3(3), physical or digital, including software	safety components and Annex II
Software in the safety component list	None	Annex II, points 18 and 19	software safety components
Protection against corruption	None	Annex III, section 1.1.9	cybersecurity in the Machinery Regulation
Control systems	Annex I, section 1.2.1: faults in the hardware or the software	Annex III, section 1.2.1(a) malicious attempts; (f) five-year tracing log	control systems under Annex III
Self-evolving behaviour	None	Annex I, Part A, points 5 and 6; section 1.2.1, data kept one year	machinery with self-evolving behaviour
Cybersecurity Act certificates	None	Presumption for sections 1.1.9 and 1.2.1 (Art. 20(9))

Essential Requirements That Change in Annex III

The essential health and safety requirements move from Annex I of Directive 2006/42/EC to Annex III of Regulation (EU) 2023/1230, which opens with nine definitions in Part A, general principles in Part B and six chapters.

The risk assessment of Part B, point 1 is the duty of "the manufacturer", where the Directive also named "his authorised representative". Six changes in the chapters are listed below.

Section 1.1.6: stress "shall be eliminated or reduced to the minimum possible", applying at least principles (a) to (g) (ergonomics under the Machinery Regulation).
Section 1.2.6 adds failure of the communication network connection (control systems under Annex III).
Section 1.3.7 adds human-machine coexistence in a shared space (essential health and safety requirements).
Sections 2.2.1.1 and 3.6.3.1 drop the Directive's 2.5 m/s² threshold for declaring hand-arm vibration (noise and vibration declarations).
Section 3.1.1(c) defines autonomous mobile machinery and section 3.2.4 its supervisory function (autonomous mobile machinery).
Section 3.5.4 on live overhead power lines is new (mobile machinery requirements).

As of 12 November 2026, Annex III is unamended in the consolidated version 02023R1230-20260727.

Instructions, Declarations and Retention Periods

Article 10(7) of Regulation (EU) 2023/1230 allows instructions in digital format on condition that the user can print, download and save them and receives paper free of charge within one month on request at the time of purchase.

Safety information for non-professional users stays on paper, and the Member State concerned determines the language, where section 1.7.4 of the Directive required official Community languages and set no paper-format rule. Content rules are explained under machinery instructions and the digital format rules.

The EU declaration of conformity keeps 10 points (Annex V, Part A) without the Directive's person authorised to compile the technical file, and point 7 adds the Official Journal publication date of each standard applied. The declaration of incorporation grows from eight to nine points.

Documents are kept at least 10 years after placing on the market or putting into service (Article 10(3)), not from the date of manufacture or last unit (Directive Annex VII, Part A, point 2).

Annex IV, Part A adds points (h) production means, (m) source code on reasoned request and (n) sensor-fed, remotely driven or autonomous machinery.

Document	Directive 2006/42/EC	Regulation (EU) 2023/1230	Detail page
Instructions	Annex I, section 1.7.4; official Community language(s); 22 points; "Original instructions" label	Art. 10(7), digital allowed; language determined by the Member State; 24 points	machinery instructions and the digital format rules
Declaration of conformity	Annex II, 1.A; 10 particulars, including the person authorised to compile the technical file	Art. 21, Annex V, Part A; 10 points	EU declaration of conformity for machinery
Declaration of incorporation	Annex II, 1.B; 8 particulars	Art. 22, Annex V, Part B; 9 points	declaration of incorporation
Assembly instructions	Annex VI	Annex XI	partly completed machinery
Technical documentation	Annex VII	Annex IV, Part A, 15 points; (h), (m) and (n) new	machinery technical file
Retention by the manufacturer	At least 10 years from manufacture or the last unit	At least 10 years after placing on the market or putting into service
Type-examination file	15 years from issue of the EC certificate (Annex IX)	Manufacturer at least 10 years (Annex VII, point 9)

Economic Operators and Modifications After Placing on the Market

Directive 2006/42/EC defined only the manufacturer and the authorised representative (Article 2(i) and (j)), while Regulation (EU) 2023/1230 names four economic operators in Article 3(22) and gives importers and distributors their own duties in Articles 13 to 16. An importer or distributor becomes the manufacturer under its own name or trademark, or by modifying a product so that compliance may be affected (Article 17).

Supplier and customer records are kept at least 10 years (Article 19(2)), as set out under obligations of economic operators under the Machinery Regulation.

An authorised representative could carry out "all or part of the obligations and formalities" under Directive Article 2(j); Article 12(1), second subparagraph, now excludes the Article 10(1) and 11(1) design duties and drawing up the technical documentation from the mandate.

Distributors now verify the CE marking, EU declaration of conformity, instructions and markings (Article 15(2)), where the Commission's Directive Guide records no explicit distributor obligations under the Directive.

Substantial modification had no Directive definition. Article 3(16) now requires a new hazard or increased risk needing (a) guards or protective devices that change the safety control system, or (b) additional stability or strength measures.

Whoever makes it is the manufacturer (Article 18), except a non-professional user for own use, and recital 26 excludes repair and maintenance; see substantial modification of machinery.

Preparing a Directive File for the Regulation

An existing Directive 2006/42/EC file becomes a Regulation (EU) 2023/1230 file in six steps, from re-checking the product's category to setting the new record-keeping periods. The steps are listed below in order.

Classify the product against Annex I and confirm its Article 25 route with the machinery conformity route finder.
Re-run the machinery risk assessment against Annex III, including sections 1.1.9 and 1.2.1.
Move the machinery technical file to Annex IV, Part A, adding points (h), (m) and (n).
Rewrite the instructions to Article 10(7) and points (a) to (x) of Annex III, section 1.7.4.2(1).
Draw up the EU declaration of conformity for machinery under Annex V, Part A; before 20 January 2027, a Directive declaration may also state conformity with the Regulation, if applicable.
Keep documents for at least 10 years after placing on the market or putting into service, and supplier and customer records for at least 10 years, as in the Machinery Regulation checklist.

Dates, Definitions and Amendments Beyond the Comparison

This comparison covers what differs between the two acts; the dates, the full list of definitions, later amendments and case law each have their own page. Six related subjects are listed below.

Dates: every Article 54 date in the Machinery Regulation timeline.
Definitions: 38 points in Article 3 against points (a) to (l) in the Directive's original Article 2 (Machinery Regulation definitions).
Amendments: Regulation (EU) 2024/2748 and Article 3 of Regulation (EU) 2026/1744; the Commission proposed COM(2025) 504 on 21 May 2025 (digital declarations), pending as of 12 November 2026 (amendments to the Machinery Regulation).
Case law: machinery case law.
Guides: Edition 2.3 (April 2024) for the Directive and a temporary and partial guide, version 1.00, for the Regulation (Guide to Application of the Machinery Directive).
Other acts: Machinery Regulation and other EU product laws.

Machinery Regulation vs Directive Questions

Four questions recur when a Directive file moves to the Regulation: the procedure, old certificates, translation labels and harmonised standards.

Who applies the conformity assessment procedure under the Regulation?

The manufacturer, or the person who carries out a substantial modification under Article 18, applies the procedure (Article 25(1) of Regulation (EU) 2023/1230). Under Article 12(1) of Directive 2006/42/EC, the manufacturer or its authorised representative applied it.

Do EC type-examination certificates issued under the Directive stay valid?

Yes: EC type-examination certificates and approval decisions issued under Article 12 of Directive 2006/42/EC remain valid until they expire (Article 52(2)). A new EU type-examination certificate under Annex VII is valid for at most five years (point 6.1).

Do instructions under the Regulation still carry translation labels?

No: the labels "Original instructions" and "Translation of the original instructions" come from Annex I, section 1.7.4.1(a) and (b) of Directive 2006/42/EC and have no counterpart in Annex III, section 1.7.4 of the Regulation. The language follows Article 10(7).

Are harmonised standards cited under the Regulation yet?

No: as of 12 November 2026, no harmonised standard is cited in the Official Journal under Regulation (EU) 2023/1230. Implementing Decision (EU) 2026/2015 repeals the Directive list, Implementing Decision (EU) 2023/1586, with effect from 20 January 2027.

Machinery Regulation vs Machinery Directive: What Changes on 20 January 2027

Summary