Machinery Directive 2006/42/EC vs Regulation 2023/1230

Hugues Orgitello updated 7 Oct 2026 22 min read

Directive 2006/42/EC has governed the placing of machinery on the European market since 29 December 2009; Regulation (EU) 2023/1230, adopted on 14 June 2023, repeals it on 20 January 2027. It covers machines, safety components, lifting accessories and partly completed machinery, with Annex IV listing twenty-three high-risk categories. Adopted under the New Approach, the directive sets the baseline of Essential Health and Safety Requirements (EHSRs) and organises the presumption of conformity through harmonised standards listed in the Official Journal. This guide presents the current scope of 2006/42/EC, the Annex IV list of high-risk machinery, the conformity assessment routes, the reference harmonised standards (EN ISO 12100, EN 60204-1, EN ISO 13849-1, EN ISO 14119), the handling of partly completed machinery, and details the key changes brought by Regulation 2023/1230, including the new cybersecurity and artificial intelligence requirements together with the transition timeline.

TL;DR:

• Regulation (EU) 2023/1230 was adopted on 14 June 2023 and published on 29 June 2023; full application on 20 January 2027, when Directive 2006/42/EC is repealed (Article 51).
• Annex IV of 2006/42/EC lists twenty-three high-risk machinery categories for which pure self-assessment is excluded.
• Machinery placed on the market before 20 January 2027 under 2006/42/EC continues to circulate under the transitional provisions (Article 52).
• The regulation adds protection against corruption (Annex III point 1.1.9) and mandatory notified-body involvement for self-evolving machine learning that performs a safety function.
• Household appliances, IT and AV equipment, office machinery and electric motors stay excluded if they fall under the LVD or now the RED, but electrically operated furniture and 3D printers are carved back in.
• Four Annex IV categories lose self-assessment in 2027: removable mechanical transmission devices, their guards, vehicle servicing lifts and cartridge-operated tools.
• The original Official Journal text says 14 January 2027; a corrigendum moved every date by six days.

Scope of Directive 2006/42/EC

Directive 2006/42/EC applies to equipment placed on the EU internal market. Article 1 defines four product categories, each with its own obligations regarding assessment, marking and documentation.

Category	Definition (Article 2)	CE marking	Declaration
Machinery	Assembly fitted with a drive system other than human or animal effort, composed of linked parts, ready for a defined application	Yes	EU declaration of conformity (Annex II 1 A)
Safety components	Components placed separately on the market, serving a safety function whose failure may endanger the safety of persons	Yes	EU declaration of conformity (Annex II 1 A)
Lifting accessories	Components or equipment not attached to the lifting machine, placed between the machine and the load or on the load	Yes	EU declaration of conformity (Annex II 1 A)
Partly completed machinery	Assembly that cannot perform a specific application on its own, intended to be incorporated into other machinery or partly completed machinery	No	Declaration of incorporation (Annex II 1 B) + assembly instructions

The scope covers industrial robots, machine tools, presses, manufacturing automation, conveyors, pumps, compressors, construction equipment, mobile elevating work platforms, powered industrial trucks, agricultural machinery and hand-held power tools. Article 1(2) lists the exclusions, among them motor vehicles, machinery specially designed for nuclear use, weapons, and machinery for military or police purposes.

The electronics exclusion, old and new

For electronics manufacturers the exclusion that matters most is the one for electrical products that another directive already covers. It changes on 20 January 2027.

Product	Directive 2006/42/EC, Article 1(2)(k)	Regulation 2023/1230, Article 2(2)(p)
Condition for exclusion	Covered by the Low Voltage Directive	Within the Low Voltage Directive 2014/35/EU or the Radio Equipment Directive 2014/53/EU
Household appliances for domestic use	Excluded	Excluded, except electrically operated furniture
Audio and video equipment	Excluded	Excluded
Information technology equipment	Excluded	Excluded
Ordinary office machinery	Excluded	Excluded, except additive printing machinery producing three-dimensional products
Low-voltage switchgear and control gear	Excluded	Excluded
Electric motors	Excluded	Excluded
High-voltage switchgear, control gear and transformers	Excluded, Article 1(2)(l)	Excluded, Article 2(2)(q)

Three consequences follow. A radio product with a motor, which falls under the RED rather than the LVD, now clearly sits inside the exclusion if it belongs to one of the listed families. A powered recliner or adjustable bed, being electrically operated furniture, is machinery. And a 3D printer is machinery even when it sits on an office desk.

The articulation with general CE marking is treated in the CE marking guide. The transversal procedure is described in the CE procedure and the directive-by-directive scope in CE scope.

Essential Health and Safety Requirements (Annex I)

Annex I structures the requirements into six parts, from design principles to specifics for lifting, mobility, agri-food applications and hand-held machinery. The EHSRs are not optional: every applicable requirement must be identified, addressed and traced in the technical file.

Section	Theme in Annex I of Directive 2006/42/EC
1.1	General remarks: definitions, principles of safety integration, materials, lighting, design for handling, ergonomics, operating positions, seating
1.2	Control systems
1.3	Protection against mechanical hazards
1.4	Required characteristics of guards and protective devices
1.5	Risks due to other hazards: electricity, static electricity, temperature, fire, explosion, noise, vibration, radiation, emissions
1.6	Maintenance
1.7	Information: warnings, marking, instructions
2	Supplementary requirements for certain categories: foodstuffs, cosmetics and pharmaceuticals, portable hand-held machinery, woodworking machinery, pesticide application
3	Hazards due to mobility
4	Hazards due to lifting operations
5	Machinery intended for underground work
6	Hazards due to the lifting of persons

Section 1.1.2, titled "Principles of safety integration", organises the hierarchy applicable to the designer:

1. Eliminate or reduce hazards through design and construction (inherent prevention).
2. Take protective measures in relation to hazards that cannot be eliminated.
3. Inform users of residual hazards through warning notices, markings and instructions.

This hierarchy is ordered: a warning does not stand in for a protective measure that was possible, and a protective measure does not stand in for a hazard that design could have removed.

Annex IV: high-risk machinery

Annex IV lists categories of machinery for which the legislator considered the risk high enough to exclude pure self-assessment and require a traced conformity route, generally with notified-body involvement or a formal quality system.

The complete list has twenty-three entries. The table gives each one, and where it goes in Annex I of Regulation 2023/1230. Part A leaves only notified-body routes; Part B keeps internal production control where harmonised standards or common specifications cover all the relevant requirements.

2006/42/EC Annex IV	Category	2023/1230 Annex I
1	Circular saws for wood or meat (four types)	Part B, 1
2	Hand-fed surface planing machinery for woodworking	Part B, 2
3	Thicknessers for one-side dressing, manual loading or unloading	Part B, 3
4	Band-saws with manual loading or unloading for wood or meat	Part B, 4
5	Combined woodworking machinery of the types in points 1 to 4 and 7	Part B, 5
6	Hand-fed tenoning machinery with several tool holders	Part B, 6
7	Hand-fed vertical spindle moulding machinery	Part B, 7
8	Portable chainsaws for woodworking	Part B, 8
9	Presses and press-brakes for cold working of metals, manual loading, travel over 6 mm and speed over 30 mm/s	Part B, 9
10	Injection or compression plastics-moulding machinery, manual loading	Part B, 10
11	Injection or compression rubber-moulding machinery, manual loading	Part B, 11
12	Underground machinery: locomotives and brake-vans, hydraulic-powered roof supports	Part B, 12
13	Manually loaded household refuse trucks with a compression mechanism	Part B, 13
14	Removable mechanical transmission devices including their guards	Part A, 1
15	Guards for removable mechanical transmission devices	Part A, 2
16	Vehicle servicing lifts	Part A, 3
17	Devices for lifting persons, or persons and goods, with a fall hazard over 3 m	Part B, 14
18	Portable cartridge-operated fixing and other impact machinery	Part A, 4
19	Protective devices designed to detect the presence of persons	Part B, 15
20	Power-operated interlocking movable guards for the machinery in points 9 to 11	Part B, 16
21	Logic units to ensure safety functions	Part B, 17
22	Roll-over protective structures (ROPS)	Part B, 18
23	Falling-object protective structures (FOPS)	Part B, 19
New	Safety components with fully or partially self-evolving behaviour using machine learning, ensuring safety functions	Part A, 5
New	Machinery with embedded systems of that kind not placed independently on the market	Part A, 6

Four existing categories therefore lose their self-assessment route on 20 January 2027: removable mechanical transmission devices, their guards, vehicle servicing lifts and cartridge-operated tools.

Conformity assessment routes

Article 12 organises three routes, depending on whether the machine falls under Annex IV and on the manufacturer's choice.

Machinery outside Annex IV

A single route applies: conformity assessment with internal checks of manufacture (Article 12 paragraph 2). The manufacturer compiles the Annex VII A technical file, performs the risk assessment under EN ISO 12100, applies relevant harmonised standards, conducts the necessary tests, issues the EU declaration of conformity and affixes the CE marking. No notified body is involved.

Machinery listed in Annex IV

Three routes are available:

1. Conditional self-assessment (Article 12 paragraph 3 point a): applicable if the machine is designed and built in full compliance with the harmonised standards published in the OJEU that cover all the applicable Annex I EHSRs. If a single EHSR is not covered by an applied harmonised standard, this route closes.
2. EC type-examination (Article 12 paragraph 4 point a): examination by a notified body of a specimen machine. The body issues an EC type-examination certificate valid for five years (renewable). The manufacturer then produces units conformant to the approved type under internal control.
3. Full quality assurance (Article 12 paragraph 4 point b), module H: the manufacturer operates a quality system covering design, production, final inspection and testing, certified and audited by a notified body. This route suits series manufacturers with a mature QMS.

Configuration	Route	Notified body
Outside Annex IV	Internal checks (Article 12.2)	No
Annex IV, harmonised standards cover all EHSRs	Self-assessment (Article 12.3 a)	No
Annex IV, harmonised standards partial or not applied	EC type-examination (Article 12.4 a)	Yes
Annex IV, series manufacturer with certified QMS	Full quality assurance H (Article 12.4 b)	Yes

For the general modular routes of the Union, see the modular conformity assessment Decision 768/2008 guide.

Harmonised standards: mapping

Directive 2006/42/EC relies on a dense corpus of harmonised standards, structured by EN ISO 12100 into three types: type A (general concepts), type B (transversal safety concepts or devices) and type C (detailed specifications by machine category).

Standard	Type	Subject	Role in assessment
EN ISO 12100	A	General design principles, risk assessment, risk reduction	Foundation standard, applies to every machine
EN 60204-1	B	Safety of electrical equipment of machines	Machine-side electrical safety: shock protection, equipotential bonding, isolation, signage
EN ISO 13849-1	B	Safety-related parts of control systems, performance levels (PL)	Determination of the required PL and achieved PL for each safety function
EN IEC 62061	B	Functional safety of electrical, electronic and programmable systems, SIL	Alternative or complement to EN ISO 13849-1 for complex functions
EN ISO 13855	B	Positioning of safeguards with respect to approach speeds of the human body	Calculation of safety distances (light curtains, pressure mats)
EN ISO 14119	B	Interlocking devices associated with guards	Selection, design and installation of interlocks
EN ISO 13851	B	Two-hand control devices, design and selection principles	Two-hand control design
EN ISO 14120	B	Fixed and movable guards, general requirements	Design of guards and protective enclosures
EN ISO 10218-1 and -2	C	Industrial robots, safety	Industrial robotics
ISO/TS 15066	Technical Specification, not harmonised	Collaborative robots (cobots), permissible forces and pressures	Most of its requirements now sit in ISO 10218-2:2025
EN 81 series	C	Lifts, goods hoists	Covered by Directive 2014/33/EU rather than the machinery directive

Recent editions matter: Implementing Decision (EU) 2026/2015 of 4 September 2026 added to the Directive's list EN ISO 10218-1:2025 and EN ISO 10218-2:2025, EN ISO 13855:2024, EN ISO 14119:2025 and EN IEC 62061:2021 with its A1:2024 amendment, without withdrawing the earlier editions; see our note on that decision. For the general mechanics of functional safety in electrical and programmable electronic systems, the IEC 61508 and SIL guide details the allocation chain across process, architecture and certification. For automotive, the ISO 26262 guide presents the neighbouring sector-specific application.

The EN ISO 12100 risk assessment remains the pivot. Type C standards covering a specific machine category explicitly refer back to EN ISO 12100 for initial assessment and to EN ISO 13849-1 or EN IEC 62061 for safety functions. The dossier construction follows the sequence: Annex I EHSRs -> hazard identification per EN ISO 12100 -> selection of relevant type B and type C standards -> determination of required PL or SIL -> design and testing -> Annex VII A technical file.

Risk assessment under EN ISO 12100

The standardised method, applicable to every machine within scope of the directive, is structured into three successive and iterative activities.

1. Hazard identification: for each lifecycle phase (assembly, transport, commissioning, setting, normal operation, degraded operation, cleaning, maintenance, dismantling), list mechanical hazards (crushing, shearing, cutting, drawing-in), electrical hazards (direct or indirect contact, discharge), thermal (burns, explosion), substance-related, noise, vibration, radiation, ergonomic and environmental hazards.
2. Risk estimation: for each identified hazard, estimate severity of harm (from minor reversible to fatal), frequency of exposure, probability of occurrence and possibility of avoiding harm. The rating is documented.
3. Risk evaluation: compare the estimated risk with the tolerable level. If not tolerable, apply risk reduction measures following the section 1.1.2 hierarchy and re-estimate. The process continues until tolerability is reached for every hazard.

Iteration is essential: introducing a protective measure can create new hazards (for instance, a movable guard creates a trapping hazard during opening), which must in turn be assessed. The technical file retains the trace of iterations, choices and their justifications.

CE marking, EU declaration of conformity and technical file

After assessment and implementation of the measures, the manufacturer materialises conformity through three elements.

CE marking

The marking is affixed to the machine in a visible, legible and indelible manner, with the minimum regulatory height of five millimetres. For the transversal rules on placement, enlargement and proportions, see the CE marking dimensions and visual rules guide.

EU declaration of conformity (Annex II 1 A)

The declaration cites Directive 2006/42/EC, identifies the machine (commercial name, serial or batch number, manufacturer), lists the applied harmonised standards (with reference and year), mentions where applicable the notified body involved and the certificate number, and is dated and signed by an authorised representative. For products covered by multiple directives, a single declaration cites all applicable acts (LVD, EMC, RED where relevant).

Technical file (Annex VII A)

The file contains:

• A general description of the machine.
• Overall drawing, control circuit diagrams, detailed drawings together with calculation notes, test results and certificates.
• Documentation on the risk assessment (identified hazards, estimates, retained measures, residual risks).
• Applied harmonised standards and the list of covered EHSRs.
• Technical reports and tests.
• A copy of the instructions for use.
• For series production, internal measures for maintaining conformity.

The file must be capable of being assembled and made available to national authorities within a period of time commensurate with its complexity (Annex VII part A point 2), and retained for ten years after the manufacture of the last unit.

Instructions for use

Under Directive 2006/42/EC (Annex I point 1.7.4.1), the instructions are drawn up in the official language(s) of the Member State in which the machinery is placed on the market or put into service. From 20 January 2027, Article 10(7) of Regulation (EU) 2023/1230 requires them to be in a language which can be easily understood by users, as determined by the Member State concerned. They cover installation, commissioning, normal operation, setting, maintenance, dismantling, residual risks, personal protective equipment to wear, declared noise and vibration values. The absence of instructions in the required language constitutes a formal non-conformity frequently raised by market surveillance.

Partly completed machinery and declaration of incorporation

Partly completed machinery is distinguished from a machine by its inability to perform a specific application on its own. An articulated robot without end-effector or controller, a hydraulic sub-assembly intended for a press, a conveyor module designed for integration into a production line are typical instances of partly completed machinery.

The partly completed machinery manufacturer issues:

• A declaration of incorporation under Annex II 1 B, listing the Annex I EHSRs that have been met among those applicable, and those that the integrator must address.
• Assembly instructions describing how to integrate the partly completed machinery while preserving conformity.
• A relevant technical file (Annex VII B) retained for ten years.

The partly completed machinery does not carry the CE marking under the machinery directive (it may nevertheless bear the marking under other directives, such as EMC or LVD). The integrator takes over the overall risk assessment and conformity of the final assembly. This upstream-downstream delegation requires a solid technical dialogue between partly-completed-machinery manufacturer and integrator, materialised by the assembly instructions.

What changes with Regulation (EU) 2023/1230?

The regulation adopted on 14 June 2023 and published on 29 June 2023 replaces Directive 2006/42/EC. Full application is set for 20 January 2027. Article 51 organises the repeal of the directive and Article 52 the transitional provisions.

The main changes are as follows.

Legal form: regulation instead of directive

Moving from directive to regulation removes the national transposition step: the text applies directly and uniformly across the twenty-seven Member States from 20 January 2027. The fragmentation of national transpositions observed since 2009 disappears.

Cybersecurity

Point 1.1.9 of Annex III, Protection against corruption, is new. It requires, in summary, that:

• connecting another device, directly or remotely, does not lead to a hazardous situation;
• hardware components that transmit signals or data relevant to accessing safety-critical software are adequately protected against accidental or intentional corruption;
• software and data critical for compliance are identified as such and protected against corruption;
• the machine identifies the software installed on it that it needs to operate safely, and can provide that information at all times;
• the machine collects evidence of legitimate or illegitimate interventions in that hardware and software.

The Regulation does not mention the Cyber Resilience Act. A connected machine may fall within both texts, and each has to be met on its own terms.

Artificial intelligence systems

The regulation introduces specific provisions for machinery whose safety functions rely on machine learning. Annex I Part A points 5 and 6 cover safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions, and machinery with embedded systems of that kind that have not been placed independently on the market. Those categories have no internal production control route: under Article 25(2) the manufacturer must use EU type-examination followed by module C, full quality assurance under module H, or unit verification under module G. A model that performs a safety function without self-evolving behaviour is not caught by Annex I Part A on that ground alone. Regulation (EU) 2024/1689 (the AI Act) no longer applies in full to such a machine. Regulation (EU) 2026/1744 of 8 July 2026, the Digital Omnibus on AI, moved machinery out of Section A of Annex I to the AI Act and into Section B, so the machine is governed through its sectoral act and, in the words of the recital, is for most purposes not directly subject to the AI Act. The equivalent protection is to be written into Annex III of this regulation by delegated act under Article 47, applying by 2 August 2028. Until AI harmonised standards exist under Regulation (EU) 2023/1230, a manufacturer may rely on those referenced under the AI Act for the presumption of conformity in Article 20. See the AI Act guide for the provisions that still reach a Section B product.

Revised high-risk list

The former Annex IV of 2006/42/EC becomes Annex I of the regulation, split into two parts. Part A lists the six categories for which Article 25(2) leaves only notified-body routes (EU type-examination plus module C, full quality assurance module H, or unit verification module G): removable mechanical transmission devices, guards for those 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, and machinery with embedded systems of that kind. The first four moved across from the old Annex IV and lose the self-assessment route on 20 January 2027. Part B keeps the nineteen remaining categories, including presence-detection protective devices and safety logic units, for which Article 25(3) still allows internal production control (module A) where harmonised standards or common specifications cover all the relevant essential health and safety requirements. Annex II of the regulation is not a risk tier: it is the indicative list of safety components.

Electronic documentation

Article 10(7) allows the instructions for use in digital format for all machinery, on conditions: the machine, or its packaging or an accompanying document, says how to access them; they can be printed, downloaded and saved, including when they are embedded in the machine's software; and they stay accessible online for the expected lifetime of the machine and at least ten years after it is placed on the market. At the user's request at the time of purchase, the manufacturer supplies a paper copy free of charge within one month. For machinery intended for non-professional users, or that they can reasonably foreseeably use, the safety information essential for putting it into service and using it safely must be supplied on paper. This evolution sits within the broader logic of dematerialised technical and documentary dossiers, addressed sectorally in the e-label vs physical label guide.

Synthetic comparison

Topic	Directive 2006/42/EC	Regulation (EU) 2023/1230
Legal form	Directive (national transposition)	Regulation (direct effect)
Application date	29 December 2009	20 January 2027
High-risk machinery	Annex IV (23 categories)	Annex I Part A (6 categories, notified body compulsory) and Part B (19 categories, module A still open under Article 25(3))
Electrical products excluded	Covered by the LVD	Within the LVD or the RED, with electrically operated furniture and 3D printers carved back in
Cybersecurity	Absent from the text	Annex III point 1.1.9, protection against corruption
AI performing a safety function	Not addressed	Listed, notified body mandatory
Instructions for use	Paper	Digital permitted, online for at least ten years, paper on request within one month, paper safety information for non-professional users
Partly completed machinery	Declaration of incorporation	Declaration of incorporation retained
Assessment routes	Self-assessment, EC type-examination, module H	Routes preserved, categories redistributed
Transitional provisions	n/a	Article 52: machinery placed on the market before 20 January 2027 under 2006/42/EC continues to circulate

When does Regulation 2023/1230 replace Directive 2006/42/EC?

Article 54 of the regulation organises a progressive entry into application. One detail trips up anyone reading the original Official Journal text: it gives 14 January 2027, 14 October 2026 and similar dates. A corrigendum published on 4 July 2023 replaced every one of them, moving each date by six days. The dates below are the corrected ones.

Date	Step	Effect
29 June 2023	Publication in the OJEU	The regulation legally exists
19 July 2023	Entry into force (+ 20 days)	Transitional provisions start running
20 January 2024	+6 months	Articles 26 to 42 apply: notifying authorities and designation of the notified bodies able to assess under the new regime
20 July 2024	+12 months	Article 6(2) to (6), (8) and (11) and Articles 47 and 53(3) apply, covering the Commission's delegated powers
20 October 2026	+39 months	Article 50(1) applies: Member States must have their penalty rules in force and, under Article 50(2), notify them to the Commission by this date
20 January 2027	+42 months, full application	Directive 2006/42/EC is repealed. Any machine placed on the market beyond this date is assessed under Regulation 2023/1230
Transitional period	Article 52	Machines placed on the market before 20 January 2027 under 2006/42/EC continue to circulate under the rules in force at their date of placing

The notion of placing on the market follows the Blue Guide meaning: first making available of an individual unit on the Union market. Storage of units awaiting sale does not constitute placing on the market; conversely, delivery to a first customer (even a reseller) marks the placing on the market of that unit. This reading guides the handling of transition units: a unit physically available on 19 January 2027 but delivered on 21 January 2027 is placed on the market after 20 January 2027 and therefore falls under the regulation.

Intermediate stocks held by importers and distributors benefit from the transitional provision only if placing on the market in the strict sense occurred before the deadline. This nuance is one of the main sources of uncertainty for manufacturers holding large series; a precise mapping of units and their legal status is recommended from 2026 onwards.

Sector-specific standards: robots, cobots, lifts, 3D printing

Industrial robots

The EN ISO 10218 series (parts 1 and 2) is the harmonised reference for industrial robots and robotic systems. Part 1 addresses the robot itself (safety architecture, stop functions, speed limiting, validation), part 2 addresses the integration of the robot into a cell (cell configuration, detection devices, integration-level validation). The 2025 editions, EN ISO 10218-1:2025 and EN ISO 10218-2:2025, were added to the Directive's list of harmonised standards by Implementing Decision (EU) 2026/2015, alongside the 2011 editions they replace, until that list ends on 20 January 2027.

Collaborative robots (cobots)

For configurations where the robot shares its workspace with a human operator without permanent physical separation, ISO/TS 15066 (a Technical Specification, not a harmonised standard) complemented the 2011 edition of EN ISO 10218-2. ISO 10218-2:2025 states that most of its requirements have been incorporated into that part: Annex M (informative) gives limits for quasi-static and transient contact, Annex N (informative) the validation of power and force limiting applications. ISO/TS 15066 specifies admissible forces and pressures on the various parts of the body in case of contact, and structures the four collaborative modes (safety-rated monitored stop, hand-guiding, speed and separation monitoring, power and force limiting). A cobot line requires a dedicated application analysis; the mere presence of a certified cobot does not presume cell conformity.

Lifts

Directive 2014/33/EU covers lifts permanently serving buildings and constructions that carry persons, persons and goods, or goods alone where the carrier is accessible and has controls inside or within reach. Its Article 1(2) leaves out, among others, lifting appliances whose speed does not exceed 0.15 m/s, construction site hoists, appliances from which work can be carried out, lifting appliances for access to workstations on machinery, and escalators and moving walkways. Those, like lifting tables, overhead cranes and hoists, are machinery. The EN 81 series is the reference for lifts; some EN 81 parts for lifting platforms and goods-only service lifts are cited under the machinery legislation instead.

3D printing

Additive manufacturing machines are machinery. Regulation 2023/1230 makes the point explicitly: its Article 2(2)(p) excludes ordinary office machinery covered by the LVD or the RED, except additive printing machinery for producing three-dimensional products. A desktop 3D printer is therefore assessed as machinery from 20 January 2027, with EN ISO 12100, EN 60204-1 and EN ISO 13849-1 as the starting point and type-B standards chosen for the process, such as laser radiation or, with metal powders, explosive atmospheres. Check the current list of cited standards before assuming that no type-C standard covers your machine.

Common pitfalls

Risk	Consequence	Action
Confusing machine and partly completed machinery	CE marking improperly affixed or declaration missing	Document the status against Article 2 and operational function
Mis-classifying an Annex IV machine as non-Annex IV	Improper self-assessment, regulatory non-conformity	Verify the exhaustive Annex IV list before route selection
Missing iteration in risk assessment	New hazards introduced by measures left untreated	Document each iteration and its outcome
Applying 2006/42/EC where Regulation 2023/1230 is required	Non-compliance from 20 January 2027	Map transition units and their legal status
Assuming a motorised radio product is machinery	Unnecessary assessment, or machinery missed when it is electrically operated furniture	Check Article 2(2)(p) of the Regulation
No protection against corruption after 2027	Annex III point 1.1.9 not met	Build protection against corruption into the risk assessment from the design stage
Incomplete or untranslated instructions for use	Formal non-conformity, withdrawal or recall by surveillance	Supply them in the language each target Member State requires (official language(s) under the Directive, a language easily understood by users, as that Member State determines, under the Regulation)
Technical file not maintained after placing on the market	Inability to demonstrate conformity in an enquiry	Hold the file for ten years, versioned archival
Confusing 2006/42/EC and 2014/33/EU for lifting equipment	Wrong assessment route, adverse surveillance	Check permanent installation and the 0.15 m/s threshold

The spilma glossary covers the key terms (machine, partly completed machinery, safety component, EHSR, EC type-examination, module H, declaration of incorporation) with their reference definitions.

See also

• ISO 13849 and IEC 62061: machinery safety
• PED 2014/68/EU: pressure equipment and categories I-IV
• MID 2014/32/EU: Measuring Instruments (MI-001 to 010)
• ATEX and IECEx: equipment for explosive atmospheres
• IEC 62368-1: safety of AV, IT and communications gear

Working on machinery directive 2006/42/EC scoping and the transition path to Regulation 2023/1230 for connected industrial machinery for a real product? AESTECHNO can audit your design and certification plan. Get in touch

Sources & references

1. Directive 2006/42/EC on machinery, EUR-Lex eur-lex.europa.eu/eli/dir/2006/42/oj
2. Regulation (EU) 2023/1230 on machinery products, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1230/oj
3. EN ISO 12100, safety of machinery, general principles for design, ISO www.iso.org/standard/51528.html
4. EN ISO 13849-1, safety-related parts of control systems, ISO www.iso.org/standard/69883.html
5. Corrigendum to Regulation (EU) 2023/1230 (OJ L 169, 4.7.2023), EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R1230R(01)
6. ISO 10218-2:2025, Robotics, safety requirements, Part 2: industrial robot applications and robot cells, ISO www.iso.org/standard/73934.html
7. Directive 2014/33/EU on lifts, EUR-Lex eur-lex.europa.eu/eli/dir/2014/33/oj
8. Commission Implementing Decision (EU) 2026/2015, Machinery Directive standards list, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2026/2015/oj
9. Guide to application of the Machinery Directive 2006/42/EC, 2.2 edition, European Commission single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en