Chapter I — General provisions

Article 1 — Subject matter¶

This Regulation lays down health and safety requirements for the design and construction of machinery, related products and partly completed machinery to allow them to be made available on the market or put into service while ensuring a high level of protection of the health and safety of persons, in particular consumers and professional users, and, where appropriate, of domestic animals and property, and, where applicable, of the environment. It also establishes rules on the free movement of products within the scope of this Regulation in the Union.

Article 2 — Scope¶

This Regulation applies to machinery and the following related products:

(a) interchangeable equipment;

(b) safety components;

(c) lifting accessories;

(d) chains, ropes and webbing;

(e) removable mechanical transmission devices.

This Regulation also applies to partly completed machinery.

For the purposes of this Regulation, machinery, the related products listed in the first subparagraph and partly completed machinery shall together be referred to as ‘products within the scope of this Regulation’.
This Regulation does not apply to:

(a) safety components that are intended to be used as spare parts to replace identical components and are supplied by the manufacturer of the original machinery, related product or partly completed machinery;

(b) specific equipment for use in fairgrounds or amusement parks;

(c) machinery and related products specially designed for use within or used in a nuclear installation and whose conformity with this Regulation may undermine the nuclear safety of that installation;

(d) weapons, including firearms;

(e) means of transport by air, on water and on rail networks except for machinery mounted on those means of transport;

(f) aeronautical products, parts and equipment that fall within the scope of Regulation (EU) 2018/1139 of the European Parliament and of the Council (21) and the definition of machinery under this Regulation, insofar as Regulation (EU) 2018/1139 covers the relevant essential health and safety requirements set out in this Regulation;

(g) motor vehicles and their trailers, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, which fall within the scope of Regulation (EU) 2018/858, except for machinery mounted on those vehicles;

(h) two- or three-wheel vehicles and quadricycles, as well as systems, components, separate technical units, parts and equipment designed and constructed for such vehicles, that fall within the scope of Regulation (EU) No 168/2013, except for machinery mounted on those vehicles;

(i) agricultural and forestry tractors, as well as systems, components, separate technical units, parts and equipment designed and constructed for such tractors, that fall within the scope of Regulation (EU) No 167/2013, except for machinery mounted on those tractors;

(j) motor vehicles exclusively intended for competition;

(k) seagoing vessels and mobile offshore units and machinery installed on board such vessels or units;

(l) machinery or related products specially designed and constructed for military or police purposes;

(m) machinery or related products specially designed and constructed for research purposes for temporary use in laboratories;

(n) mine winding gear;

(o) machinery or related products intended to move performers during artistic performances;

(p) the following electrical and electronic products, insofar as they fall within the scope of Directive 2014/35/EU or of Directive 2014/53/EU:

(i) household appliances intended for domestic use which are not electrically operated furniture;

(ii) audio and video equipment;

(iii) information technology equipment;

(iv) ordinary office machinery, except additive printing machinery for producing three-dimensional products;

(v) low-voltage switchgear and control gear;

(vi) electric motors;

(q) the following high-voltage electrical products:

(i) switchgear and control gear;

(ii) transformers.

Article 3 — Definitions¶

For 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.

Article 4 — Free movement¶

Member States shall not impede, for reasons relating to the aspects covered by this Regulation, the making available on the market of products within the scope of this Regulation or the putting into service of machinery or related products which comply with this Regulation.
At trade fairs, exhibitions and demonstrations or similar events, Member States shall not prevent the display of a product within the scope of this Regulation which does not comply with this Regulation, provided that a visible sign clearly indicates that it does not comply with this Regulation and will not be made available on the market until it has been brought into conformity.

During demonstrations, adequate measures shall be taken to ensure the protection of persons.

Member States may lay down requirements to ensure that persons, including workers, are protected when installing or using machinery or related products, provided that such rules do not allow for the modification of machinery or a related product in a way that is not compatible with this Regulation.

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).
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.
Before adopting a delegated act, the Commission shall seek the views of experts in the relevant expert group in accordance with Article 47(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.

(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.

In determining the probability and severity of harm, the following criteria shall, where relevant, be taken into account:
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.
The data and information referred to in paragraph 5, points (a) to (d), shall be provided by Member States in accordance with paragraph 9.
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.
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.
By 14 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.
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 20 July 2024.
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.

Article 7 — Safety components¶

An indicative list of safety components is set out in Annex II.
The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex II in the light of technical progress and knowledge or new scientific evidence by including a new safety component in the indicative list of safety components or withdrawing an existing safety component from that list.
A Member State which has concerns about a safety component being listed or not listed in Annex II shall immediately inform the Commission of its concerns and provide reasons in support thereof.

Article 8 — Essential health and safety requirements for products within the scope of this Regulation¶

Machinery 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.

Article 9 — Specific Union harmonisation legislation¶

Where, for a certain product within the scope of this Regulation, the risks addressed by the essential health and safety requirements set out in Annex III are wholly or partly covered by Union harmonisation legislation that is more specific than this Regulation, this Regulation shall not apply to that product to the extent that that specific Union legislation covers such risks.