Frequently asked questions on Regulation (EU) 2023/1230 on machinery

No, and it is important to be clear: "Passeport Machine" is the name of our service, not a document required by the Regulation. What the Regulation requires are specific documents: the technical documentation under Annex IV, the instructions under Article 10(7), the EU declaration of conformity under Annex V, marking, and keeping all of these for ten years. Our passport brings these documents together around an identified machine, with its test log and standards monitoring. It is not an additional obligation: it is our method for making existing obligations manageable. No one can fault you for not having a "machinery passport"; they can fault you for failing to present your technical documentation.

From 20 January 2027. The text published in OJ L 165 of 29 June 2023 indeed stated "14 January 2027" in Article 54, second paragraph. The corrigendum published in OJ L 169, 4 July 2023, page 35 replaced it with "20 January 2027": points 5, 6, and 10 of the corrigendum correct Article 51(2), Article 52(1), and Article 54, respectively. The pitfall can still be seen today: the uncorrected HTML version on EUR-Lex still displays "14 January 2027", whereas the consolidated text contains the corrigendum tag and the date of 20 January. The legally applicable date is the corrected one.

None for newly placed products on the market. Article 54 makes the Regulation applicable from 20 January 2027, and Article 51(2) repeals Directive 2006/42/EC with effect from that same date: there is no period during which both texts coexist at the manufacturer's choice. The only provision is Article 52(1), discussed below. In contrast, several provisions already applied earlier: Articles 26 to 42, on the notification of conformity assessment bodies, from 20 January 2024; Article 6(7) and Articles 48 and 52 from 19 July 2023. Article 50(1) on penalties applies from 20 October 2026: this is the closest upcoming deadline in the schedule.

No. Article 10(1) imposes obligations on manufacturers "When placing machinery or a related product on the market or putting it into service" machinery, and Article 3, point 12, defines placing on the market as the first making available on the Union market. Machinery already placed on the market before 20 January 2027 remains governed by Directive 2006/42/EC, as confirmed by Article 52(1). Two caveats matter in practice. A substantial modification reopens the assessment and makes the person carrying it out a manufacturer (Article 3, point 16, and Article 18). Furthermore, an employer's obligations regarding its installed machinery base—inspections, training, maintenance in safe condition—fall under separate legislation and remain in force: Article 5 also expressly reserves the power of Member States to lay down requirements for installation and use.

A distinction must be made between two situations often confused in practice. Article 52(1) protects products "which were placed on the market" in accordance with the Directive before 20 January 2027; and Article 3, point 12, defines placing on the market as the first making available. Machinery still in the manufacturer's warehouse on that date has therefore not been placed on the market, regardless of its year of manufacture; a unit already supplied to a distributor has been placed on the market, and can continue to be made available under the Directive. What matters is the date of the first supply, not the manufacturing date nor the date of the invoice to the end customer. The Regulation specifies no standard proof: traceability of that date must be documented on a machine-by-machine basis via delivery note or contract.

The Regulation contains no specific provisions governing second-hand products: the expression appears only in recital 10, which refers to products "new or second-hand" imported from a third country. Qualification therefore hinges on placing on the market (Article 3, points 11 and 12). Second-hand machinery resold within the Union has already been placed on the market: it does not fall within the scope of the Regulation, subject always to the caveat of substantial modification (Article 18). Conversely, second-hand machinery imported from a third country is placed on the Union market for the first time: the person introducing it is an importer within the meaning of Article 3, point 20, and bears the obligations of Article 13, whose paragraph 2 presupposes technical documentation and marking established by the manufacturer. A recognized point of uncertainty: the Regulation does not resolve the case where the original manufacturer no longer exists; in practice, Article 17 turns the importer into a manufacturer as soon as they place the product on the market under their own name.

Article 2(1) defines the scope: machinery, partly completed machinery, and five families of related products—interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices. Article 2(2) then lists seventeen exclusions, from points (a) to (q). Among the most useful to know: safety components supplied by the machinery manufacturer as spare parts to replace identical components; weapons; means of transport by air, on water and on rail networks, except for machinery mounted on them; vehicles covered by Regulations (EU) 2018/858, 168/2013 and 167/2013, except for machinery mounted on them; sea-going vessels and mobile offshore units; machinery for military or police purposes; mine winding gear; and certain electrical and electronic products falling within Directives 2014/35/EU or 2014/53/EU—in particular household appliances, audio and video equipment, and information technology equipment—though additive manufacturing equipment for producing three-dimensional products is expressly not excluded.

Annex IV, Part A lists fifteen elements, from points (a) to (o). The baseline is familiar: a comprehensive description and intended use, risk assessment documentation with the list of applicable essential requirements and the description of protective measures, drawings and diagrams with the necessary explanations, reports and results of calculations and tests, means used during production, and a copy of the instructions for use. Two elements are specific to the Regulation and missing from most dossiers inherited from the Directive: point (m), which provides for making available the source code or programming logic of safety-related software upon reasoned request from a national authority; and point (n), which requires, for sensor-fed, remotely controlled or autonomous machinery whose safety-related operations are controlled by sensor data, a description of the general characteristics, capabilities, limitations, data, and development, testing and validation processes. Finally, point (e) requires specifying, in the event of partial application of a standard, which parts have been applied.

At least ten years. Article 10(3) obliges manufacturers to keep the technical documentation and the EU declaration of conformity at the disposal of the market surveillance authorities for at least ten years after the machinery product has been placed on the market or put into service. Article 19(2) adds a separate and often overlooked obligation: to retain for at least ten years the identity of any economic operator who supplied them with a product, and that of any economic operator to whom they have supplied one. If the EU declaration is provided in digital format, the second subparagraph of Article 10(8) requires that it remain accessible online for the expected lifetime of the product and, in any event, for at least ten years. The authorised representative keeps the same documents at disposal (Article 12(2)(a)), but their mandate can never cover the drawing up of the technical documentation nor the design obligation of Article 10(1).

It depends entirely on Annex I, and the answer has changed compared with the Directive. Three scenarios arise. If the category does not appear in Annex I, internal production control applies — Module A, Annex VI — without a notified body (Article 25(4)). If it appears in Annex I, Part B, Module A is only possible provided that the machine has been designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all the relevant essential health and safety requirements; failing that, the third subparagraph of Article 25(3) refers to EU type-examination followed by Module C, to Module H, or to Module G. If it appears in Annex I, Part A, Module A is completely ruled out under any circumstances: Article 25(2) opens only three routes, all requiring a notified body.

Article 21(1) sets out its purpose: it states that the fulfilment of the applicable essential requirements set out in Annex III has been demonstrated. Paragraph 2 determines its form: the model structure of Annex V, Part A, supplemented by the elements specified in the relevant module applied (Annexes VI, VIII, IX, or X), continuously updated and translated into the language or languages required by the Member State in which the machinery product is placed on the market, made available, or put into service. Paragraph 3 requires a single declaration where several Union acts require one, identifying those acts and their publication references. Paragraph 4 is the briefest and carries the most weight: by drawing up the declaration, the manufacturer assumes responsibility for compliance. It may be digital: Article 10(8) permits providing an internet address or a machine-readable code in the instructions for use, on condition that it remains accessible for at least ten years.

Article 24(1) requires the marking to be affixed visibly, legibly, and indelibly to the machinery product; packaging and accompanying documents are only permitted where that is not possible or not warranted on account of the nature of the machinery product. Paragraph 2 fixes the timing: before the product is placed on the market or put into service. Paragraph 3 adds the identification number of the notified body where the procedure applied requires its intervention, namely in the cases set out in points (a), (b), and (c) of Article 25(2) and points (b), (c), and (d) of Article 25(3). The general principles remain those of Article 30 of Regulation (EC) No 765/2008, to which Article 23 refers. Added to this are the identification markings of Article 10(5) — designation of the machinery model, series or type, year of construction, batch or serial number —, the manufacturer's contact details with a single contact point (Article 10(6)), and the specific marking required by Annex III, Section 1.7.3.

You are. Article 3, point 18(a) defines as a manufacturer any person who manufactures products or has those products designed or manufactured, and markets them under their name or trademark. Subcontracting the design therefore transfers no legal obligation: the technical documentation, the EU declaration, and the CE marking remain yours, and the second subparagraph of Article 12(1) even expressly excludes from an authorised representative’s mandate the drawing up of the technical documentation and the design obligation of Article 10(1). What is negotiated is the contract: which deliverables the engineering design office provides — calculations, test reports, schematics, and, where applicable, the source code or programming logic of the safety software required by Annex IV, Part A, point (m) —, in what format, and with what commitment to availability over the ten years required by Article 10(3).

Yes, without exception. Article 3, point 18(b) defines as a manufacturer any person who manufactures products falling within the scope of the Regulation and puts them into service for their own use. Special-purpose machinery built by the manufacturing engineering department, test benches, or internally assembled lines are therefore subject to the Regulation in the same way as a machine sold on the market: risk assessment pursuant to Annex III, Part B, technical documentation pursuant to Annex IV, Part A, conformity assessment procedure pursuant to Article 25, followed by the EU declaration and CE marking under Article 10(2). There is no exemption for in-house use. The exception in the third paragraph of Article 18 applies only to a non-professional user modifying their own machine, and does not apply to manufacturing.

Two new requirements in Annex III and two routes to a presumption of conformity. Section 1.1.9, “protection against corruption”, requires that connection to another device, including remotely, does not lead to a hazardous situation; that hardware and software essential for conformity are identified and protected against accidental or intentional corruption; that the machinery product collects evidence of any legitimate or illegitimate intervention; and that it is capable of providing at all times, in an easily accessible manner, information on the installed software necessary for it to operate safely. Section 1.2.1 extends the reliability of control systems to “reasonably foreseeable malicious attempts from third parties”, restricts actions of machinery with self-evolving behaviour to their defined task and movement zone, and sets two retention periods: one year for data on the decision-making process (machinery with self-evolving behaviour), and five years for recording interventions and versions of safety software uploaded (all control systems). Regarding presumption, Article 20(9) recognises certificates issued under a cybersecurity scheme of Regulation (EU) 2019/881 for these two sections; and Regulation (EU) 2026/1744 of 8 July 2026, in its Article 3, tasks the Commission with adding requirements reflecting those of the Artificial Intelligence Act to Annex III, via delegated acts applicable no later than 2 August 2028.

Article 3, point 16 sets out three cumulative conditions and a final alternative that is rarely cited. The modification is carried out by physical or digital means after the product has been placed on the market or put into service; it is neither foreseen nor planned by the manufacturer; and it affects the safety by creating a new hazard or increasing an existing risk. Furthermore, it must require either (a) the addition of guards or protective devices whose processing necessitates the modification of the existing safety-related control system, or (b) the adoption of additional protective measures to ensure stability or mechanical strength. Without this final requirement, the qualification does not apply. The retrofit guide details the evaluation grid.

The first paragraph of Article 18 considers any natural or legal person who carries out a substantial modification to be a manufacturer and subjects them to the obligations of Article 10. The scope is more precise than is often assumed: if the modification only affects the safety of a machine that is part of an assembly of machinery, the obligations only apply to the affected machine, as demonstrated in the risk assessment. The second paragraph adds two specific obligations: to declare on their sole responsibility that the machinery product is in conformity, and to apply the conformity assessment procedure referred to in Article 25(2), (3), and (4). In other words, the scope can be defended, but solely on the basis of a written risk assessment, which reverses the burden of proof in the event of an inspection.

Only a non-professional user escapes this classification. The third paragraph of Article 18 provides that a non-professional user who carries out a substantial modification on their machine, for their own use, shall not be considered a manufacturer and shall not be subject to the obligations of Article 10. However, Article 3, point 36 defines a professional user as any natural or legal person who uses or operates a machinery product in the course of their professional activity or work. The consequence is clear: a company that substantially modifies its own machine for its own production, without ever selling it, receives no exemption. It is a manufacturer under Article 18, with all the technical documentation and declaration obligations that entails.

No, provided the replacement is foreseen by the manufacturer and leaves safety unchanged: Article 3, point 16 requires a modification neither foreseen nor planned by the manufacturer, and an impact on safety, and the need for additional protective measures. The Regulation goes further in one specific case: Article 2(2)(a) excludes from its scope safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery. Even so, it remains advisable to document in writing that the question was evaluated. What creates exposure is not maintenance itself, but the lack of an audit trail on the day an inspection or accident inquiries into the basis on which the change was deemed non-substantial.

The Regulation does not impose any template; this must be stated frankly, and anyone claiming otherwise should be viewed with scepticism. It imposes, instead, a result. Article 18, first paragraph, circumscribes the scope of obligations “as demonstrated in the risk assessment”. And Annex III, Part B, point 1, describes the expected process: determining the limits of the machinery, including reasonably foreseeable misuse; identifying hazards and hazardous situations; estimating and then evaluating risks; finally, reducing them according to the order of priority in section 1.1.2, point (b). A useful assessment therefore includes a description of the modification, the criteria of Article 3, point 16, examined one by one — including alternative (a) or (b) —, the reasoned conclusion, the date and the signatory. If the conclusion is “substantial”, the technical documentation of Annex IV, Part A, must be deployed; if not, the signed table provides proof that the question has been resolved.

Yes, and the text says so explicitly: Article 3, point 16, refers to modifications made “by physical or digital means”. The criteria remain the same, providing a workable boundary: an update planned and provided for by the manufacturer in its initial assessment does not satisfy the first criterion; a rewrite of the safety logic written by an integrator, requiring new guards and a modification of the safety control system, satisfies all of them. The issue also extends beyond the Machinery Regulation: Directive (EU) 2024/2853, on liability for defective products, considers in its Article 8(2) as manufacturer of the product any person who substantially modifies it outside the manufacturer's control and subsequently places it on the market or puts it into service.

Article 3, point 20, defines the importer as a person established in the Union who places a product from a third country on the Union market; read alongside Article 3, point 12, it refers to the person who introduces it, not to whoever subsequently resells it. The latter is a distributor within the meaning of Article 3, point 21: any person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market. The distributor has its own checklist under Article 15(2): that the machinery bears the CE marking; that it is accompanied by the EU declaration referred to in Article 10(8); that it is accompanied by the instructions for use and the information referred to in Article 10(7), in a language which can be easily understood by users, as determined by the Member State in which the machinery is to be made available on the market; and that the manufacturer and the importer have complied, respectively, with Article 10(5) and (6), and Article 13(3). Article 15(1) sums up the spirit: acting with due care in relation to the requirements of the Regulation.

Article 13(2), first subparagraph, lists four checks, no more, no less: that the appropriate conformity assessment procedures referred to in Article 25 have been carried out by the manufacturer; that the manufacturer has drawn up the technical documentation referred to in Annex IV, Part A; that the machinery bears the CE marking referred to in Article 23 and is accompanied by the required documents; and that the manufacturer has complied with Article 10(5), (6) and (8). To these are added three specific obligations: ensuring that the machinery is accompanied by the instructions for use and information referred to in Article 10(7) (paragraph 4); indicating their own name and contact details on the machinery or, where that is not possible, on its packaging or in a document accompanying it (paragraph 3); and ensuring that storage or transport conditions do not jeopardise conformity while the product is under their responsibility (paragraph 5). Paragraph 1 fits into a single sentence: importers shall place on the market only compliant machinery.

They must be able to have it produced, which is not the same thing. Article 13(8), first subparagraph, requires that, for at least ten years after placing on the market, they keep a copy of the EU declaration of conformity at the disposal of authorities and ensure that the technical documentation can be made available to those authorities, upon request. The nuance is contractual: the documentation may remain in the hands of the manufacturer, but the importer guarantees that it can be produced, which entails a written, enforceable undertaking and a responsive contact address. The second subparagraph extends the same logic to the source code or programming logic, which shall be made available upon a reasoned request from a national authority where necessary to verify compliance with the requirements of Annex III.

The importer, throughout the entire chain of Article 13, none of whose obligations are contingent upon the manufacturer's cooperation. If the manufacturer has not drawn up the technical documentation of Annex IV, Part A, Article 13(2) purely and simply prohibits placing on the market: there is no option to sell first and regularise later. Once the product is placed on the market, Article 13(7) requires immediate corrective action, withdrawal or recall, and, where the machinery presents a risk, immediately informing the competent national authorities of the Member States concerned. A manufacturer established outside the Union may appoint an authorised representative (Article 12), but Article 12(1), second subparagraph, excludes the drawing up of the technical documentation and the design obligation of Article 10(1) from the mandate: the documentation must still be drawn up, by someone, and that someone bears the risk.

No, and this is the most predictable source of litigation in the coming years. The CE marking is merely an assertion by the manufacturer itself (Article 3, point 25); Article 13(2) obliges the importer to verify that the applicable procedure was genuinely followed and that the documentation exists. Two points require particular vigilance with imported robotic cells and safety equipment. On the one hand, Annex I, Part A, points 5 and 6, cover safety components and machinery with embedded systems having fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions: for these, Article 25(2) rules out Module A, and the intervention of a notified body is mandatory. On the other hand, Annex I, Part B, point 15, covers protective devices designed to detect the presence of persons — light curtains, laser scanners —, for which Module A presupposes harmonised standards covering all relevant requirements. See the standards section: on this specific point, the issue is not purely theoretical.

You become the manufacturer. Article 17 is explicit: an importer or distributor shall be considered a manufacturer, and shall be subject to the obligations of Articles 10 and 11, where they place a product on the market under their name or trademark, or modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected. The threshold for this second case is significantly lower than that for a substantial modification under Article 3, point 16: it is enough that conformity may be affected, without needing to demonstrate a new hazard or new protective measures. Private-label rebranding is therefore not a neutral commercial operation: it transfers the technical documentation, the EU declaration, the marking, and liability under Article 21(4).

In principle, no. Article 10(7), first subparagraph, provides that “The instructions may be provided in a digital format”. But two mandatory reservations remain, and they are the stumbling blocks. First, if requested by the user at the time of the purchase, the manufacturer shall provide the instructions for use in paper format free of charge within one month (third subparagraph). Second, for machinery intended for non-professional users — or which may, under reasonably foreseeable conditions, be used by them even if not intended for them —, the safety information essential for putting into service and safe use must be provided in paper format (fourth subparagraph). The guide to digital instructions details their practical implementation.

Article 10(7), second subparagraph, lists them. (a) The manufacturer shall indicate on the machinery — or, where that is not possible, on its packaging or in an accompanying document — how to access the digital instructions. (b) Provide them in a format that makes it possible for the user to print and download them and save them on an electronic device so that they can be accessed at all times, “in particular during a breakdown of the machinery”; this requirement also applies where the instructions are embedded in the software of the machinery. (c) Make them accessible online during the expected lifetime of the machinery and for at least ten years after the placing on the market. The lifetime is defined in Article 3, point 34, and extends up to the moment the machinery is discarded, including the stages of dismantling and scrapping.

From the request, and that request must be made “at the time of purchase” (Article 10(7), third subparagraph). The text does not, therefore, create a permanent right to paper, exercisable years later: it creates a right at the time of purchase, which the manufacturer must then honour free of charge within a maximum of one month. The consequence is as much commercial as regulatory: the question must be asked during the sales process, and the answer must be recorded. The Regulation says nothing about the form of the request, proof of delivery, or what happens to a late request: these are areas left to contract, and it is better to treat them as such rather than pretend they are settled.

Article 10(7), last subparagraph, requires that instructions for use, safety information and the information set out in Annex III be provided “in a language which can be easily understood by users, as determined by the Member State concerned”, and that they be clear, understandable and legible. It is therefore the destination Member State that determines the language, not the manufacturer or the sales contract. There is only one exception, in Annex III, section 1.7.4, second paragraph: instructions for maintenance intended for specialised personnel mandated by the manufacturer or their authorised representative may be supplied in a single official language of the Union that is understood by that personnel. Furthermore, the distributor verifies this point prior to making available on the market (Article 15(2), point (c)).

Annex III, section 1.7.4.2, point 1, lists their contents from point (a) to (x). From (a) to (u): business name and full address of the manufacturer and, where applicable, of their authorised representative; designation of the machinery, except for the serial number; EU declaration of conformity, or the internet address or machine-readable code where it can be accessed; general description; drawings, diagrams and explanations necessary for the use, maintenance and repair; description of workstations; intended use; warnings concerning ways in which, from experience, the machinery must not be used; assembly, installation and connection instructions; reduction of noise and vibration; putting into service and, where appropriate, training of operators; residual risks; protective measures to be taken by the user, including personal protective equipment; characteristics of tools which may be fitted; stability; transport, handling and storage, with the mass indicated; operating method in the event of an accident or breakdown; adjustment and maintenance; spare parts affecting safety; and airborne noise emission values based on the thresholds of 70 dB(A), 63 Pa and 80 dB(A). Section 1.7.4.1 adds two drafting principles: taking into account reasonably foreseeable misuse and the level of training that can reasonably be expected from non-professional operators.

No, and the blocking point can be verified with the article in hand. A one-off transmission satisfies neither condition a) — access must be indicated on the machinery — nor condition c) — the instructions must remain accessible online during the expected lifetime and for at least ten years. Nor does it make it possible to answer the question asked by an authority or an expert following an incident: what exact version accompanied this machinery when it was placed on the market? The instructions are indeed a component of the technical documentation: Annex IV, Part A, point (i), requires a copy of the instructions for use and the information set out in section 1.7.4 to be included therein. What the text requires is therefore not a file, but a permanent, versioned access point whose history can be proven.

None. Article 20(1) restricts the presumption of conformity to products that comply with harmonised standards "the references of which have been published in the Official Journal of the European Union", under the applicable legal text. As of 26 August 2026, the Commission's "Machinery" page only lists acts adopted under Directive 2006/42/EC, and no implementing decision citing standards under Regulation (EU) 2023/1230 has been found on EUR-Lex. Citations under the Directive currently appear in Implementing Decision (EU) 2023/1586 of 26 July 2023, which repealed Decision (EU) 2019/436, amended six times — most recently by Decision (EU) 2026/546 of 12 March 2026, consolidated version 02023D1586-20260515. A date for a first batch (late 2026) is circulating in the trade press: it does not come from the Commission, and we state this clearly. The reference standards page sets out this dual status, standard by standard.

Not as an automatic presumption. The presumption is tied to a citation published in the Official Journal under the applicable legal text (Article 20(1)); a citation made under Directive 2006/42/EC, repealed as of 20 January 2027 by Article 51(2), does not automatically transfer its effect to the Regulation. Technically, nothing prevents applying the same standard: Annex IV, Part A, point (f), expressly covers the case where harmonised standards have not been applied, or have only been partially applied, and then requires a description of the other technical specifications applied to satisfy each applicable essential requirement. The difference between the two situations is not legal, it is documentary: it is a demonstration workload that must be factored into the schedule.

The 2023 version. Implementing Decision (EU) 2024/1329 of 13 May 2024, published in the Official Journal on 15 May 2024, inserted row 66a "EN ISO 13849-1:2023" into Annex I to Decision 2023/1586 and deleted row 66, which contained the 2015 version. However, its Article 3 makes this deletion applicable from 15 May 2027: both versions therefore coexist today, and the 2015 version ceases to confer a presumption on 15 May 2027, that is to say almost four months after the date of application of the Regulation. Any documentation that still cites the 2015 version must be updated before that date, and there is no reason to wait, since the superseding version has been cited since 2024.

Because no version of this standard has conferred a presumption of conformity since 19 September 2020. Implementing Decision (EU) 2019/1863 of 6 November 2019, published in OJ L 286 on 7 November 2019, withdrew the reference EN 61496-1:2013 with effect from that date, on the expressly stated grounds that it no longer satisfied the requirements it aimed to cover — and without a replacement standard. As for the 2020 version, it was never cited: a full-text search in the Commission summary list of 30 March 2026 yields no results. The consequence is rarely pursued to its conclusion: protective devices designed to detect the presence of persons are listed in Annex I, Part B, point 15, and module A under Article 25(3), point (a), presupposes a design compliant with harmonised standards covering all relevant essential requirements. In the absence of a cited standard, the internal control route is closed and the third subparagraph of that same paragraph points to EU type-examination, module H or module G.

Not in its current form. Article 20(1) refers to harmonised standards within the meaning of Article 3, point 24, of the Regulation, which refers to point (c) of Article 2(1) of Regulation (EU) No 1025/2012: a technical specification does not fall within that category, and a full-text search for "15066" in the Commission summary list of 30 March 2026 yields no results. It remains a useful state of the art, which must be cited as such in the documentation, never as the basis for a presumption. Pending citations under the Regulation, the procedure required is that of the text: risk assessment according to Annex III, Part B; Annex IV, Part A, points (e) and (f) — specifying precisely which standards have been applied, in whole or in part, and which other technical specifications cover the remainder. Two relief valves exist: Article 20(3) allows the Commission to adopt common specifications by means of implementing acts, which confer the same presumption (paragraph 6); and Article 20(10), introduced by Regulation (EU) 2026/1744, allows, on a transitional basis, reliance on the harmonised standards or common specifications of the Artificial Intelligence Act for high-risk AI systems. The Directive / Regulation comparison outlines these differences point by point.

Market surveillance authorities, under Regulation (EU) 2019/1020, to which the Machinery Regulation refers. Article 43(1) sets out the mechanism: as soon as they have sufficient reason to believe that a product presents a risk, they evaluate the product covering all relevant requirements laid down in this Regulation, and "The relevant economic operators shall cooperate as necessary". Where they find non-compliance, they require the economic operator without delay to take corrective action pursuant to Article 16(3) of Regulation (EU) 2019/1020 within a period proportionate to the nature of the risk, and inform the relevant notified body. If the measures are not taken, Article 43(4) requires them to ensure that the product is withdrawn or recalled, or that its being made available on the market is prohibited or restricted, and to ensure that the public is informed immediately.

Everything that demonstrates conformity, and nothing unrelated to it. Article 10(10) for the manufacturer, Article 13(9) for the importer, and Article 15(6) for the distributor are worded in virtually identical terms: upon a reasoned request from a competent national authority, the economic operator shall provide all the information and documentation necessary, in paper or digital format, in a language easily understood by that authority, and cooperate in any action to eliminate the risks. Added to this are the documents kept available for ten years (Article 10(3)), the identification of suppliers and customers kept for ten years (Article 19), and — only upon a reasoned request, and only where necessary to verify compliance with the requirements of Annex III — the source code or programming logic of the safety-related software (Article 10(3), second sentence, and Annex IV, Part A, point (m)). Annex III, section 1.2.1, also provides for specific logs, usable exclusively to demonstrate conformity upon a reasoned request: that of interventions and uploaded safety software versions, maintained for five years, for any control system; that of decision-making data, retained for one year, for machinery with self-evolving behaviour.

The Regulation does not fix any amount, and one should be wary of figures circulating. Article 50(1) tasks Member States with laying down the rules on penalties applicable to infringements committed by economic operators, penalties that "effective, proportionate and dissuasive" and "may include criminal penalties for serious infringements". Paragraph 2, as corrected, sets 20 October 2026 as the deadline for Member States to notify those rules to the Commission: this is the earliest deadline in the timetable, ahead of the date of application itself. Alongside penalties, Article 46 governs formal non-compliance, often the first to be established: CE marking not affixed or affixed in breach of the rules, notified body identification number missing, EU declaration not drawn up or drawn up incorrectly, technical documentation unavailable or incomplete, details under Article 10(6) or Article 13(3) missing, false or incomplete. The Member State requires this to be corrected; if the situation persists, it restricts or prohibits the making available on the market, or ensures that the product is recalled or withdrawn (Article 46(3)).

Two regimes overlap, and confusing them proves costly. Regarding product conformity, Article 21(4) is explicit: by drawing up the EU declaration, the manufacturer assumes responsibility for the conformity of the machinery. Article 17 extends this status to the importer or distributor who places their trademark or modifies the product, and Article 18 to whoever makes a substantial modification. Regarding compensation for damage, Directive (EU) 2024/2853 of 23 October 2024 on liability for defective products applies: it repeals Directive 85/374/EEC with effect from 9 December 2026, the deadline also set for its transposition (Articles 21 and 22), while the old directive continues to govern products placed on the market or put into service before that date. Its Article 8(1) covers the manufacturer of the product, the manufacturer of the component, and, where the manufacturer is established outside the Union, the importer, the authorised representative, and subsequently the fulfilment service provider; its Article 8(2) treats as a manufacturer anyone who substantially modifies a product outside the manufacturer's control and subsequently makes it available on the market again. These legal texts are to be examined with counsel, based on the specific facts of each case: we do not provide legal advice.

Three sets of matters, which are frequently confused with it. Use at work, first of all: the obligations of the employer regarding their machinery stock — periodic inspections, operator training, maintenance in a state of conformity — fall under Directive 2009/104/EC of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by workers at work, and its national transposition, not under the Regulation; furthermore, Article 5 expressly reserves the possibility for Member States to lay down requirements for installation and use, provided they do not allow machinery to be modified in a way that is not compatible with the Regulation. Excluded products, secondly, listed in Article 2(2). The remainder of conformity, finally: a machine is often subject to other Union acts, which Article 21(3) addresses by requiring a single EU declaration citing all applicable acts. And conformity itself is never delegable. Conformity rests with the manufacturer. The importer assumes the specific obligations of Article 13: they place on the market only compliant machinery, and verify that the assessment procedure has been carried out and that the technical documentation exists. They become the manufacturer themselves in the cases set out in Article 17. Our role is to assist in drafting the documentation, not to replace you.