Machinery Regulation

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Article 6Categories of machinery and related products listed in Annex I subject to relevant conformity assessment procedures1.Machinery and related products that fall within the categories listed in Annex I, Part A, shall be subject to the specific conformity assessment procedures referred to in Article 25(2), and machinery and related products that fall within the categories listed in Annex I, Part B shall be subject to the specific conformity assessment procedures referred to in Article 25(3).2.The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex I, after consulting the stakeholders concerned, in the light of technical progress, advances in knowledge or new scientific evidence by adding to the list of categories of machinery and related products in Annex I a new category of machinery or related products, withdrawing an existing category of machinery or related products from that list or moving a category of machinery or related products from one Part of Annex I to another Part of that Annex, in accordance with the criteria and the procedures laid down in paragraphs 4, 5 and 7 of this Article.3.Before adopting a delegated act, the Commission shall seek the views of experts in the relevant expert group in accordance with Article 47(4).4.The Commission shall assess the seriousness of the inherent potential risk presented by a category of machinery or related product for the purpose of determining whether to add that category of machinery or related product to Annex I or to withdraw that category of machinery or related product from Annex I. That assessment shall be established based on the combination of the probability of occurrence of harm and the severity of that harm.In determining the probability and severity of harm, the following criteria shall, where relevant, be taken into account:(a)the nature of the hazard inherent to the function of the category of machinery or related product, taking into account the intended use and any reasonably foreseeable misuse;(b)the severity of harm which a person would suffer, including the degree of reversibility of that harm;(c)the number of persons potentially affected by the harm;(d)the frequency and the duration of the exposure to the hazard that a person would be exposed to in the course of the intended use or any reasonably foreseeable misuse of the category of machinery or related product;(e)the possibilities of avoiding or limiting harm;(f)in the case of safety components, the likelihood of serious consequences for the safety of the persons exposed to harm in the event of their failure.5.When conducting the assessment referred in paragraph 4, the Commission shall consider the following elements:(a)indications of harm that have been caused in the past by machinery or related products which have been used for their intended use or following any reasonably foreseeable misuse;(b)information about safety defects detected in the course of market surveillance, and material possibly available in the information systems administered by the Commission;(c)information about known accidents and serious close calls, including the characteristics of those accidents or close calls;(d)data on accidents or damage to health caused by the machinery or related product for at least the preceding four years. In particular, information obtained, inter alia, from the Information and Communication System on Market Surveillance (ICSMS), safeguard clauses, Safety Gate Rapid Alert System, the European Injury Database (EU-IDB), Eurostat’s European Statistics on Accidents at Work (ESAW) and the Machinery Administrative Cooperation Group (AdCo).In addition to points (a) to (d) of this paragraph, the Commission shall take into account any other information available that is relevant to the assessment referred to in paragraph 4.6.The data and information referred to in paragraph 5, points (a) to (d), shall be provided by Member States in accordance with paragraph 9.7.A category of machinery or related product shall be included in Annex I, Part A, if, according to the assessment referred to in paragraph 4, and taking into account the available information, including the data referred to in paragraph 5, it presents a serious inherent potential risk, and one or more of the following conditions is fulfilled:(a)there is a lack of harmonised standards or common specifications covering the relevant essential health and safety requirements;(b)residual risks exist, including those which, according to the manufacturer, could be reduced by particular training or personal protective equipment, and the data and information referred to in paragraph 5, demonstrate the recurrence of similar serious or fatal accidents or damage to health in connection with those residual risks;(c)data and information exist which according to the Commission demonstrate recurring wrongful application of the relevant harmonised standards or common specifications and for which the market surveillance activities that were carried out have not led to major improvements of the market situation, in a reasonable period;(d)there is a degree of uncertainty in the existing risk assessment methods related to new categories of machinery or technologies.Any other category of machinery or related product that, according to that assessment, presents a serious inherent potential risk but does not fulfil one or more of the conditions in points (a) to (d) shall be included in Annex I, Part B.8.A Member State which has concerns about a category of machinery or related product being listed or not in Annex I shall immediately inform the Commission of those concerns and provide reasons in support thereof.The Commission shall conduct the assessment referred to in paragraph 4 immediately after being informed by a Member State.After making that assessment, the Commission may initiate the procedure laid down in paragraph 2.9.By 14 20 July 2025, and every five years thereafter, Member States shall provide the data and information referred to in paragraph 5, including information to the effect that none of the events referred to in paragraph 5 has occurred, for every category of machinery or related products which is included in Annex I or which is not included in Annex I where that non-inclusion is a cause of concern for the Member State.10.The Commission shall adopt implementing acts setting out and, where necessary in the light of technological and market development, updating a template concerning the collection by Member States of the data and the information referred to in paragraph 5, points (a) to (d).When adopting those implementing acts, the Commission shall issue guidance to Member States on the collection and transmission of comparable, high-quality data and information.Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).The first such implementing act shall be adopted not later than 14 20 July 2024.11.If necessary after the Commission report referred to in Article 53(3), the Commission shall adopt delegated acts in accordance with Article 47 to supplement paragraph 5 of this Article by specifying the obligations of Member States to provide data and information required pursuant to this Article through the establishment of a common methodology concerning the data and information to be collected, including the methods for their collection and compilation, and the procedures for their transmission, as well as the relevant definitions, in order to ensure that sufficient and comparable data is available for the Commission to carry out the assessment referred to in paragraph 4.

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Article 47Exercise of the delegation1.The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.2.The power to adopt delegated acts referred to in Articles 6(2), 6(11) and 7(2) shall be conferred on the Commission for a period of five years from 13 19 July 2023. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.3.The delegation of power referred to in Articles 6(2), 6(11) and 7(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.4.Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.5.As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.6.A delegated act adopted pursuant to Articles 6(2), 6(11) or 7(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

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Article 50Penalties1.Member States shall lay down the rules on penalties applicable to infringements by economic operators of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive and may include criminal penalties for serious infringements.2.Member States shall, by 14 20 October 2026, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

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Article 51Repeals1.Directive 73/361/EEC is repealed.References to the repealed Directive 73/361/EEC shall be construed as references to this Regulation.2.Directive 2006/42/EC is repealed with effect from 14 20 January 2027.References to the repealed Directive 2006/42/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XII.

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Article 52Transitional provisions1.Member States shall not impede the making available on the market of products which were placed on the market in conformity with Directive 2006/42/EC before 14 20 January 2027. However, Chapter VI of this Regulation shall apply, from 13 19 July 2023, mutatis mutandis to such products instead of Article 11 of that Directive, including products for which a procedure has already been initiated under Article 11 of Directive 2006/42/EC.2.EC type-examination certificates and approval decisions issued in accordance with Article 12 of Directive 2006/42/EC shall remain valid until they expire.

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Article 53Evaluation and review1.By 14 20 July 2028 and every four years thereafter, the Commission shall submit a report on the evaluation and review of this Regulation to the European Parliament and to the Council. The reports shall be made public.2.Taking account of technical progress and practical experience gained in Member States as indicated in Article 6, the Commission shall in its report include an evaluation on the following aspects of this Regulation:(a)the essential health and safety requirements set out in Annex III;(b)the conformity assessment procedure applicable to machinery or related products listed in Annex I.Where appropriate, the report shall be accompanied by a legislative proposal for amendment of the relevant provisions of this Regulation.3.By 14 20 July 2026 and every five years thereafter, the Commission shall submit a specific report on the assessment of Article 6(4) and (5) of this Regulation to the European Parliament and to the Council. The reports shall be made public.The Commission shall include in its reports the following:(a)a summary of data and information provided by Member States in accordance with Article 6(5) during the reporting period;(b)an assessment of the list of categories of machinery or related products in Annex I in view of the criteria set out in Article 6(4).In the reports, the Commission shall assess the appropriateness and availability of data and information provided by Member States, including its sufficiency and suitability for the purposes of making comparisons, identifying any shortcomings, necessary to ensure effective functioning and enforcement of Article 6.

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Article 54Entry into force and applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 14 20 January 2027.However, the following Articles shall apply from the following dates:(a)Articles 26 to 42 from 14 20 January 2024;(b)Article 50(1) from 14 20 October 2023;(c)Article 2026;(c)Article 6(7) and Articles 48 and 52 from 13 19 July 2023;(d)Article 6(2) to (6), (8) and (11) and Articles 47 and 53(3) from 14 20 July 2024.

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before (02023R1230-20260529)

Article 8Essential health and safety requirements for products within the scope of this RegulationMachinery or related products shall only be made available on the market or put into service if, where properly installed and maintained and used for their intended use or under conditions which can reasonably be foreseen, they meet the essential health and safety requirements set out in Annex III.Partly completed machinery shall only be made available on the market if it meets the relevant essential health and safety requirements set out in Annex III.

after (02023R1230-20260727)

Article 8Essential health and safety requirements for products within the scope of this RegulationMachinery or related products shall only be made available on the market or put into service if, where properly installed and maintained and used for their intended use or under conditions which can reasonably be foreseen, they meet the essential health and safety requirements set out in Annex III.Partly completed machinery shall only be made available on the market if it meets the relevant essential health and safety requirements set out in Annex III.The Commission shall adopt delegated acts in accordance with Article 47 of this Regulation to amend Annex III to this Regulation by adding health and safety requirements in respect of Artificial Intelligence (AI) systems that are classified as high-risk pursuant to Article 6(1) of Regulation (EU) 2024/1689 of the European Parliament and of the CouncilRegulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj). due to the fact that they are a safety component in a product covered by this Regulation, or they are themselves a product covered by this Regulation. Those requirements shall ensure that the relevant requirements set out in Chapter III, Section 2, and Articles 17, 19, 72 and 73 of Regulation (EU) 2024/1689 are reflected.When adopting the delegated acts referred to in the third paragraph, the Commission shall take into account the objectives of Regulation (EU) 2024/1689 and ensure a level of protection consistent with that Regulation. Those delegated acts shall apply by 2 August 2028.

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Article 20Presumption of conformity of products within the scope of this Regulation1.A product within the scope of this Regulation which is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III covered by those standards or parts thereof.2.The Commission shall, as provided in Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards for the essential health and safety requirements set out in Annex III.3.The Commission may adopt implementing acts establishing common specifications covering technical requirements that provide a means to comply with the essential health and safety requirements set out in Annex III for products within the scope of this Regulation.Those implementing acts shall only be adopted where the following conditions are fulfilled:(a)the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements set out in Annex III and:(i)the request has not been accepted; or(ii)the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or(iii)the harmonised standards do not comply with the request; and(b)no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex III has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period.Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).4.Before preparing the draft implementing act referred to in paragraph 3, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 3 have been fulfilled.5.When preparing the draft implementing act referred to in paragraph 3, the Commission shall take into account the views of relevant bodies or the expert group and shall duly consult all relevant stakeholders.6.A product within the scope of this Regulation which is in conformity with the common specifications established by implementing acts referred to in paragraph 3, or parts thereof, shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III covered by those common specifications or parts thereof.7.Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 3, or parts thereof which cover the same essential health and safety requirements as those covered by that harmonised standard.8.When a Member State considers that a common specification does not entirely satisfy the essential health and safety requirements set out in Annex III, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.9.Machinery and related products that have been certified or for which a statement of conformity has been issued under a cybersecurity certification scheme adopted in accordance with Regulation (EU) 2019/881 the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III, sections 1.1.9 and 1.2.1, as regards protection against corruption and safety and reliability of control systems insofar as those requirements are covered by the cybersecurity certificate or statement of conformity or parts thereof. thereof.10.Until harmonised standards or common specifications are referenced or adopted pursuant to this Article as regards high-risk AI systems, high-risk AI systems within the scope of this Regulation which comply with the relevant harmonised standards referenced, or common specifications adopted pursuant to Articles 40 and, respectively, 41 of Regulation (EU) 2024/1689 shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III to this Regulation as regards high-risk AI systems.

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Article 47Exercise of the delegation1.The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.2.The power to adopt delegated acts referred to in Articles 6(2), 6(11) Article 6(2) and 7(2) (11) and Article 7(2), shall be conferred on the Commission for a period of five years from 19 July 2023. The power to adopt delegated acts referred to in Article 8, third paragraph, shall be conferred on the Commission for a period of five years from 27 July 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not no later than three months before the end of each period.3.The delegation of power referred to in Articles 6(2), 6(11) Article 6(2) and (11), Article 7(2) and Article 8, third paragraph, may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.4.Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.5.As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.6.A delegated act adopted pursuant to Articles 6(2), 6(11) Article 6(2) and (11), Article 7(2) or 7(2) Article 8, third paragraph, shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

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Article 3DefinitionsFor the purposes of this Regulation, the following definitions apply:(1)machinery means:(a)an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application;(b)an assembly referred to in point (a), missing only the components to connect it on site or to sources of energy and motion;(c)an assembly referred to points (a) and (b), ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure;(d)assemblies of machinery referred to in points (a), (b) and (c), or of partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;(e)an assembly of linked parts or components, at least one of which moves, and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;(f)an assembly as referred to in points (a) to (e) missing only the uploading of the software intended for the specific application foreseen by the manufacturer;(2)interchangeable equipment means a device which, after the putting into service of machinery or an agricultural or forestry tractor, is assembled with that machinery or agricultural or forestry tractor by the operator in order to change its function or to attribute a new function to it, provided that the device is not a tool;(3)safety component means a physical or digital component, including software, of a product within the scope of this Regulation, which is designed or intended to fulfil a safety function and which is independently placed on the market, the failure or malfunction of which endanger the safety of persons, but which is not necessary in order for that product to function or for which normal components may be substituted in order for that product to function;(4)safety function means a function that serves to fulfil a protective measure designed to eliminate, or, if that is not possible, to reduce, a risk, which, if it fails, could result in an increase of that risk;(5)lifting accessory means a component or equipment, not attached to the lifting machinery, which enables the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market, including slings and their components;(6)chains means chains designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;(7)ropes means ropes designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;(8)webbing means webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;(9)removable mechanical transmission device means a removable component for transmitting power between self-propelled machinery or a tractor and other machinery or related products by joining them at the first fixed bearing; when it is placed on the market with a guard, the device and the guard are to be regarded as one item;(10)partly completed machinery means an assembly which is not yet machinery as it cannot in itself perform a specific application and which is only intended to be incorporated into or assembled with machinery or other partly completed machinery or equipment, thereby forming machinery;(11)making available on the market means any supply of a product within the scope of this Regulation for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;(12)placing on the market means the first making available of a product within the scope of this Regulation on the Union market;(13)putting into service means the first use, for its intended purpose, in the Union, of machinery or related products;(14)essential health and safety requirements means the mandatory provisions, set out in Annex III, relating to the design and construction of products within the scope of this Regulation to ensure a high level of protection of the health and safety of persons, and, where appropriate, domestic animals and property, and, where applicable, of the environment;(15)Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products;(16)substantial modification means a modification of machinery or a related product, by physical or digital means after that machinery or related product has been placed on the market or put into service, which is not foreseen or planned by the manufacturer, and which affects the safety of that machinery or related product, by creating a new hazard, or by increasing an existing risk, which requires:(a)the addition of guards or protective devices to that machinery or related product the processing of which necessitates the modification of the existing safety control system; or(b)the adoption of additional protective measures to ensure the stability or mechanical strength of that machinery or related product;(17)instructions for use means the information, provided by the manufacturer when the machinery or related product is placed on the market or put into service, to inform the user of the machinery or related product, of the intended and proper use of that machinery or related product, as well as information on any precautions to be taken when using or installing the machinery or related product, including information on the safety aspects, and on how to keep that machinery or related product safe, and to ensure that it remains fit for purpose during its entire lifetime;(18)manufacturer means any natural or legal person who:(a)manufactures products within the scope of this Regulation or who has those products designed or manufactured, and markets those products under its name or trademark; or(b)manufactures products within the scope of this Regulation, and puts those products into service for its own use;(19)authorised representative means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks;(20)importer means any natural or legal person established within the Union who places a product within the scope of this Regulation from a third country on the Union market;(21)distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product within the scope of this Regulation available on the market;(22)economic operator means the manufacturer, the authorised representative, the importer or the distributor;(23)technical specifications means a document that prescribes technical requirements to be fulfilled by products within the scope of this Regulation;(24)harmonised standard means a harmonised standard as defined in Article 2, point 1, point (c), of Regulation (EU) No 1025/2012;(25)CE marking means a marking by which the manufacturer indicates that machinery or a related product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing;(26)accreditation means accreditation as defined in Article 2, point (10), of Regulation (EC) No 765/2008;(27)national accreditation body means a national accreditation body as defined in Article 2, point (11), of Regulation (EC) No 765/2008;(28)conformity assessment means the process for demonstrating whether the applicable essential health and safety requirements in this Regulation relating to machinery or related products have been fulfilled;(29)conformity assessment body means a body that performs conformity assessment activities, including calibration, testing, certification and inspection;(30)notified body means a conformity assessment body notified in accordance with this Regulation;(31)market surveillance authority means a market surveillance authority as defined in Article 3, point (4), of Regulation (EU) 2019/1020;(32)recall means any measure aimed at achieving the return of a product within the scope of this Regulation that has already been made available to a user;(33)withdrawal means, for a product, any measure aimed at preventing a product within the scope of this Regulation that is in the supply chain from being made available on the market;(34)lifetime means the period from the moment that machinery or a related product is placed on the market or put into service until the moment that it is discarded, including the effective time when the machinery or related product is capable of being used and the phases of transport, assembly, dismantling, disabling, scrapping or other physical or digital modifications foreseen by the manufacturer;(35)source code means the currently installed version of the software of a product within the scope of this Regulation, written in a programming language so that it is unambiguous and understandable to humans;(36)professional user means a natural person who uses or operates machinery or a related product in the course of his or her professional activity or work. work;(37)crisis-relevant goods means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the CouncilRegulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).;(38)internal market emergency mode means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

inserted text (02023R1230-20260529)

Article 25aApplication of emergency procedures1.Articles 25b to 25e of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to machinery and related products covered by this Regulation.2.Articles 25b to 25e of this Regulation shall apply only to machinery and related products which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.3.Articles 25b to 25e of this Regulation shall apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.However, Article 25c(7) of this Regulation shall apply during the internal market emergency mode and after its expiry or deactivation.4.The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to machinery and related products placed on the market or put into service in accordance with Articles 25c and 25d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).

inserted text (02023R1230-20260529)

Article 25bPrioritisation of the conformity assessment of machinery and related products designated as crisis-relevant goods1.This Article applies to all types of machinery and related products listed in the implementing act referred to in Article 25a(1) that are subject to the conformity assessment procedures referred to in Article 25 that require the mandatory involvement of a notified body.2.The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of machinery and related products referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 25a.3.The prioritisation of applications for a conformity assessment of machinery and related products pursuant to paragraph 2 shall not result in additional disproportionate additional costs for the manufacturers, who have lodged those applications.4.The notified bodies shall make reasonable efforts to increase their testing capacities for machinery and related products referred to in paragraph 1 in respect of which they have been notified.

inserted text (02023R1230-20260529)

Article 25cDerogation from conformity assessment procedures requiring the mandatory involvement of a notified body1.By way of derogation from Article 25, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market or putting into service within the territory of that Member State, of specific machinery or related products listed in the implementing act referred to in Article 25a(1) and for which the conformity assessment procedures referred to in Article 25 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential health and safety requirements set out in Annex III has been demonstrated in accordance with procedures referred to in that authorisation.2.The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential health and safety requirements laid down in Annex III, the Commission shall adopt, without delay, an implementing act extending for a limited period of time the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific machinery or related products may be placed on the market or put into service. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 48(3).The machinery or related products subject to the extension of validity referred to in the first subparagraph shall bear the information that they are placed on the market or put into service as a crisis-relevant good. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.3.On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 48(4).4.As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.5.Manufacturers of machinery or of related products subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the machinery or the related products concerned comply with all the applicable essential health and safety requirements set out in Annex III and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.6.Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the machinery or the related products may be placed on the market or put into service. Such authorisations shall set out at least the following:(a)a description of the procedures by means of which compliance with the applicable essential health and safety requirements set out in Annex III to this Regulation was successfully demonstrated;(b)any specific requirements regarding the traceability of the machinery and the related products concerned;(c)an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;(d)any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the machinery and the related products concerned;(e)measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the machinery or the related products concerned that have been placed on the market or put into service.7.By way of derogation from Articles 4, 23 and 24, machinery or related products for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 4 shall not apply.8.The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such machinery and related products, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under this Regulation. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.9.The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 25.

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Article 25dPresumption of conformity based on standards and common specifications1.Where machinery or related products have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications for such machinery or related products to cover the applicable essential health and safety requirements set out in Annex III to this Regulation in the following cases:(a)where a reference to harmonised standards covering the applicable essential health and safety requirements set out in Annex III to this Regulation has not been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period; or(b)where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the applicable essential health and safety requirements set out in Annex III to this Regulation and the references of which have already been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.2.The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.3.The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 48(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.4.Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Regulation and shall duly consult all relevant stakeholders.5.Without prejudice to Article 20, machinery and related products that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential health and safety requirements set out in Annex III that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.6.By way of derogation from Article 25a(3), first subparagraph, unless there is sufficient reason to believe that the machinery and the related products covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the machinery and the related products that are in conformity with those standards or common specifications and which have been placed on the market or put into service shall be deemed to be in conformity with the applicable essential health and safety requirements set out in Annex III after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.7.When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the applicable essential health and safety requirements set out in Annex III, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

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Article 25ePrioritisation of market surveillance activities and mutual assistance among authorities1.The Member States shall prioritise the market surveillance activities for machinery and related products listed in the implementing act referred to in Article 25a(1) of this Regulation. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.2.The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support, such as the reinforcement of the testing capacity for machinery and the related products listed in the implementing act referred to in Article 25a(1).

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