Regulation on machinery

Article 1 Subject matter

Article 2 Scope

The regulation applies to machinery and related products including interchangeable equipment, safety components, lifting accessories, chains, ropes, webbing, and removable mechanical transmission devices, as well as partly completed machinery. It does not apply to spare components identical to originals from the original manufacturer, amusement park equipment, nuclear installation equipment, weapons, transport vehicles and aircraft except mounted machinery, motor vehicles and related components except mounted machinery, certain agricultural tractors except mounted machinery, competition vehicles, seagoing vessels, military and police equipment, temporary research equipment, mine winding gear, performer-moving machinery, and certain electrical and electronic products already covered by other directives.

Article 3 Definitions

Machinery is an assembly with a drive system (other than human or animal effort) with linked moving parts for a specific application, or such an assembly missing only site connection or software, or requiring mounting or building installation, or multiple machinery operating as an integral whole, or a manually-powered lifting assembly; related terms define interchangeable equipment, safety components and safety functions. Additional definitions cover partly completed machinery, placing on the market, putting into service, essential health and safety requirements, substantial modification, and instructions for use. Manufacturer, authorised representative, importer, distributor, and professional user are defined; conformity assessment is the compliance demonstration process, notified bodies perform assessment activities, lifetime spans from placing on market or putting into service until discard including all foreseeable transport, assembly and modification phases, and source code is the currently-installed software version.

Article 4 Free movement

Member States must not prevent machinery and related products within the regulation's scope from being marketed or put into service if they comply. At events like trade fairs, non-compliant products may be displayed only with a visible sign indicating non-compliance and a commitment not to market them until corrected; adequate safety measures must protect persons during demonstrations.

Article 5 Protection of persons during installation or use of machinery or related products

Member States may establish requirements to protect persons, including workers, during installation or use of machinery and related products, provided these requirements do not permit modifications incompatible with this regulation.

Article 6 Categories of machinery and related products listed in Annex I subject to relevant conformity assessment procedures

Machinery in Annex I Part A and Part B must undergo specific conformity assessment procedures; the Commission may delegate authority to amend Annex I based on assessment of inherent potential risk considering hazard nature, harm severity, affected population, exposure frequency and duration, and harm avoidance possibilities, drawing on past harm data, safety defects, accidents and close calls from databases and systems. Categories enter Part A if presenting serious inherent risk and lacking harmonised standards, showing recurring serious accidents related to residual risks, demonstrating recurring misapplication of standards despite surveillance, or involving uncertainty in new technologies; otherwise serious-risk categories go in Part B. Member States must report concerns about listing decisions; the Commission must assess them immediately and may initiate amendment procedures.

Article 7 Safety components

An indicative list of safety components appears in Annex II. The Commission may amend this list through delegated acts based on technical progress and new scientific evidence. Member States must immediately inform the Commission of any concerns about a component's listing status with supporting reasons.

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

Machinery and related products must meet the essential health and safety requirements in Annex III before being marketed or put into service, when properly installed, maintained and used as intended or under reasonably foreseeable conditions. Partly completed machinery must also meet applicable requirements in Annex III before marketing.

Article 9 Specific Union harmonisation legislation

Article 10 Obligations of manufacturers of machinery and related products

Manufacturers must ensure machinery and related products comply with essential health and safety requirements, prepare technical documentation and EU declarations of conformity, affix CE markings, and keep documentation available to authorities for at least 10 years (providing source code to competent authorities on reasoned request if needed). They must ensure products bear identification (model, construction year, batch or serial number) and their name and single contact point in a readily understood language on the product, packaging or accompanying documents. They must provide instructions and Annex III information in downloadable and printable format for access during breakdowns, kept online for the product's expected lifetime plus at least 10 years after market placement, with free paper copies supplied on request within one month; they must supply or provide online access to the EU declaration of conformity for at least 10 years and immediately take corrective action, withdraw or recall products, and inform national authorities when non-conformity or risks to health, safety or environment are discovered.

Article 11 Obligations of manufacturers of partly completed machinery

Manufacturers of partly completed machinery must ensure compliance with essential health and safety requirements, prepare technical documentation retained for at least 10 years, and draw up an EU declaration of incorporation; they must disclose source code or programming logic on reasonable request by national authorities, maintain procedures for ongoing compliance despite manufacturing changes, affix identification details to machinery or documentation, and provide contact details in an easily understood language. Assembly instructions must be provided in printable and downloadable digital format allowing continuous access including during breakdowns, remaining online for at least 10 years after market placement, with free paper instructions supplied within one month on request; the EU declaration of incorporation must be provided with the product or accessible online for at least 10 years. Upon discovering non-conformity, manufacturers must immediately take corrective action and inform national authorities if risks to essential health and safety requirements exist, and must provide all requested information and documentation to competent national authorities in a readily understood language and cooperate on risk elimination actions.

Article 12 Authorised representatives

Article 13 Obligations of importers of machinery and related products

Importers must place only compliant machinery on the market and verify before doing so that the manufacturer has performed conformity assessment, prepared technical documentation, applied CE marking, complied with other specified requirements, and met documentation obligations. Importers must not place non-compliant machinery on the market until corrected, and must inform manufacturers and surveillance authorities of risks to health, safety, animals, property or the environment. Importers must display their contact details on the machinery or its packaging in user-friendly language, ensure accompanying instructions are provided, maintain storage and transport conditions that preserve conformity, and conduct sample testing, monitor complaints and recalls as appropriate to protect health and safety.

Article 14 Obligations of importers of partly completed machinery

Importers must place only conformant partly completed machinery on the market and verify before doing so that the manufacturer has prepared technical documentation, included required documents, and complied with marking and contact information requirements. If an importer suspects non-conformity, they may not place the machinery on the market until it is brought into conformity and must notify the manufacturer and market surveillance authorities if it presents hazards. Importers must display their contact details on the machinery or documentation in an understandable language, ensure assembly instructions accompany the machinery, and maintain storage and transport conditions that preserve conformity.

Article 15 Obligations of distributors of machinery and related products

Distributors must exercise due care when placing machinery or related products on the market. Before distribution, they must verify that the product displays a CE marking, includes a conformity declaration and user instructions in an understandable language, and that manufacturers or importers have met their legal obligations. Distributors must not distribute non-conforming products and must inform manufacturers and authorities if a product poses health, safety, or environmental risks.

Article 16 Obligations of distributors of partly completed machinery

Distributors of partly completed machinery must act with due care and verify before distribution that the product includes an incorporation declaration and assembly instructions in an understandable language, and that manufacturers or importers have complied with applicable requirements. They must not distribute non-conforming products and must inform manufacturers and authorities if partly completed machinery poses safety risks. Storage and transport conditions must not jeopardise safety compliance, and distributors must take corrective action, withdraw or recall non-conforming products.

Article 17 Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor that places a product on the market under its own name, trademark or brand, or modifies an existing product in a way that could affect compliance with requirements, shall be treated as a manufacturer and must fulfil all manufacturer obligations under this Regulation.

Article 18 Other cases in which obligations of manufacturers apply

Article 19 Identification of economic operators

Economic operators must identify to market surveillance authorities on request any suppliers from whom they received products within the regulation's scope and any customers to whom they supplied such products, and must keep this information for at least 10 years after the transaction.

Article 20 Presumption of conformity of products within the scope of this Regulation

Products conforming to published harmonised standards or to common specifications adopted by the Commission are presumed to meet essential health and safety requirements. When a European standards body proposes a harmonised standard for Official Journal publication, the Commission assesses it under EU standardisation rules and repeals implementing acts covering the same safety requirements. Member States may notify the Commission if they believe a common specification does not fully address essential safety requirements, and products certified under approved cybersecurity schemes are presumed to comply with control system safety and corruption protection requirements if covered by the cybersecurity certification.

Article 21 EU declaration of conformity of machinery and related products

The EU declaration of conformity must state that applicable essential health and safety requirements have been met, must follow the model in Annex V Part A with elements from specified modules, must be continuously updated and translated into required languages, and may be consolidated with other declarations under different Union legal acts. By preparing this declaration, the manufacturer assumes responsibility for the product's compliance.

Article 22 EU declaration of incorporation of partly completed machinery

The EU declaration of incorporation must state that applicable essential health and safety requirements have been met, must follow the model in Annex V Part B, must be continuously updated and translated into required languages, and may include a conformity declaration for other applicable Union legal acts. By preparing this declaration, the manufacturer assumes responsibility for the partly completed machinery's compliance.

Article 23 General principles of the CE marking

Article 24 Rules for affixing the CE marking to machinery and related products

Manufacturers must affix CE markings visibly, legibly and indelibly to machinery or related products, or if impractical, to packaging and accompanying documents, before placing on market or putting into service. Where conformity assessment involves a notified body, the body's identification number must follow the CE marking, applied by the body itself or its designee.

Article 25 Conformity assessment procedures for machinery and related products

Manufacturers must apply one of several conformity assessment procedures depending on machinery category: categories in Annex I Part A require type-examination followed by internal production control, full quality assurance, or unit verification; categories in Annex I Part B may use internal production control if designed to harmonised standards, otherwise type-examination, full quality assurance or unit verification; uncategorised machinery requires internal production control. Notified bodies must consider small and medium enterprise interests when setting fees.

Article 26 Notification

Member States must notify the Commission and other Member States of bodies authorised to conduct third-party conformity assessment activities under this regulation.

Article 27 Notifying authorities

Each Member State must designate a notifying authority responsible for assessing and notifying conformity assessment bodies and monitoring their compliance. The authority may delegate these tasks to a national accreditation body or other legal entity, but remains fully responsible for those tasks and the delegated body must comply with independence and liability requirements.

Article 28 Requirements relating to notifying authorities

Notifying authorities must avoid conflicts of interest with conformity assessment bodies, maintain objectivity and impartiality, ensure notification decisions are taken by different persons than assessors, refrain from offering conformity assessment or commercial consultancy services, protect information confidentiality, and employ sufficient competent personnel.

Article 29 Information obligation of notifying authorities

Member States must inform the Commission of their procedures for assessing, notifying and monitoring conformity assessment bodies, and any changes to those procedures, which the Commission must make publicly available.

Article 30 Requirements relating to notified bodies

Notified bodies must be independent third-party legal entities established under Member State law, separate from machinery designers, manufacturers or suppliers they assess, with personnel free from conflicting roles and consultancy services; they must execute conformity assessment with highest professional integrity and technical competence, free from pressures influencing judgment, and have access to necessary personnel, procedures, policies and equipment. Personnel must have sound technical and vocational training in assessment activities, knowledge of essential health and safety requirements and applicable standards, and ability to document assessments; notified body impartiality must be guaranteed including through compensation independent of assessment numbers or results. Bodies must carry liability insurance unless the Member State assumes liability, observe professional secrecy regarding assessment information, protect intellectual property, and participate in standardisation activities and notified body coordination.

Article 31 Presumption of conformity of notified bodies

A conformity assessment body that demonstrates compliance with applicable harmonised standards published in the Official Journal is presumed to meet the requirements for notification.

Article 32 Use of subcontractors and subsidiaries by notified bodies

Notified bodies may subcontract or delegate tasks to subsidiaries only if they ensure those parties meet the notification requirements, inform the notifying authority, and retain full responsibility for their work. Subcontracting or use of subsidiaries requires the client's prior agreement, and the notified body must maintain documentation on its assessment of their qualifications and their work.

Article 33 Application for notification

A conformity assessment body must apply to the notifying authority in its Member State, providing a description of its activities and competence, plus either an accreditation certificate from a national accreditation body or, if unavailable, documentary evidence demonstrating compliance with notification requirements.

Article 34 Notification procedure

The notifying authority sends notifications through an electronic Commission tool, including details of the conformity assessment activities, modules, machinery types, and attestation of competence. The body may act as a notified body only if no objections are raised within two weeks for accredited bodies or two months for those providing documentary evidence. Subsequent changes to the notification must be reported to the Commission and other Member States.

Article 35 Identification numbers and lists of notified bodies

The Commission assigns a single identification number to each notified body and maintains a publicly available list of notified bodies, their numbers, and their conformity assessment activities.

Article 36 Changes to notifications

Article 37 Challenge of the competence of notified bodies

The Commission may investigate any doubts about a notified body's competence or continued compliance with its obligations. The notifying Member State must provide information on request to support the notification. If the Commission finds non-compliance, it shall adopt an implementing act requesting corrective measures, including withdrawal if necessary.

Article 38 Operational obligations of notified bodies

Notified bodies must conduct conformity assessments according to regulatory procedures in a proportionate manner while maintaining required rigor and protection levels. They must require manufacturers to take corrective action and refuse to issue or must suspend/withdraw approval certificates when essential health and safety requirements are not met or no longer met.

Article 39 Appeals against decisions of notified bodies

Notified bodies must provide a transparent and accessible procedure for appeals against their decisions.

Article 40 Information obligation of notified bodies

Notified bodies must report to the notifying authority refusals or withdrawals of approval certificates, circumstances affecting their notification scope, requests from market surveillance authorities, and details of their conformity assessment activities. They must also share relevant information with other notified bodies on negative conformity assessment results and, on request, positive results for similar machinery.

Article 41 Exchange of experience

The Commission shall facilitate the sharing of experience among the Member States' national authorities that handle notification decisions.

Article 42 Coordination of notified bodies

The Commission shall establish and maintain a sectoral group of notified bodies to coordinate and cooperate effectively. Bodies that are notified under this Regulation shall take part in that group's activities, either directly or through designated representatives.

Article 43 Procedure at national level for dealing with products within the scope of this Regulation presenting a risk

Market surveillance authorities must evaluate products they have reason to believe present a risk to health, safety, animals, property or environment, require operators to take proportionate corrective action within a reasonable period, and inform the relevant notified body, Commission and other Member States where non-compliance may extend beyond their territory. If operators fail to apply corrective action throughout the Union within the specified period or non-compliance persists, authorities shall withdraw, recall or restrict the product's availability on the market. Information shared must detail identification, origin, non-compliance nature and risk, measures taken, and whether non-compliance stems from failure to meet essential health and safety requirements, shortcomings in harmonised standards or shortcomings in common specifications; a provisional measure is deemed justified if no objection is raised within three months, and Member States shall apply appropriate restrictive measures such as withdrawal without delay.

Article 44 Union safeguard procedure

Where objections to a Member State measure arise or the Commission considers it to be contrary to Union law, the Commission shall consult stakeholders and evaluate it, then adopt a decision determining whether the measure is justified. If justified, all Member States shall ensure appropriate restrictive measures are taken and shall inform the Commission; if unjustified, the Member State shall withdraw its measure. If justified non-compliance is attributed to shortcomings in harmonised standards or common specifications, the Commission shall apply procedures under Regulation (EU) No 1025/2012 or Article 20(8) respectively.

Article 45 Compliant products within the scope of this Regulation which present a risk

When a Member State finds that a product compliant with essential safety requirements nonetheless poses a risk to health, safety, animals, property or the environment, it must require the relevant operator to take appropriate corrective measures, withdraw or recall the product within a reasonable timeframe. The Member State must immediately inform the Commission and other Member States with full details of the product, risk and measures taken. The Commission must evaluate the national measures and adopt an implementing decision confirming whether they are justified, and may order appropriate measures; urgent decisions may be adopted immediately to protect health and safety.

Article 46 Formal non-compliance

Where a Member State finds specific formal non-compliance with machinery or related products, such as incorrect or missing CE marking, missing or incorrect notified body identification number, incorrectly or incompletely drawn up EU declaration of conformity, unavailable or incomplete technical documentation, or absent, false or incomplete required information or other unfulfilled administrative requirements, it shall require the operator to remedy the non-compliance. For partly completed machinery, similar findings regarding EU declaration of incorporation, technical documentation and information shall trigger the same requirement. If non-compliance persists, the Member State shall restrict, prohibit, recall or withdraw the product from the market.

Article 47 Exercise of the delegation

The Commission receives delegated power for a five-year period starting 13 July 2023, with automatic renewal unless Parliament or Council objects three months before each period ends. Either Parliament or Council can revoke the delegation at any time, and the Commission must consult Member State experts and notify both institutions of each delegated act; the act enters into force only if neither institution objects within two months of notification, with a possible two-month extension.

Article 48 Committee procedure

A committee shall assist the Commission on matters covered by this Regulation and shall apply the control procedures set out in Regulation (EU) No 182/2011. The committee shall be consulted on matters requiring expert input under other Union legal acts and may examine other issues raised by its chair or Member State representatives.

Article 49 Confidentiality

All parties must keep confidential personal data and commercially sensitive information obtained in applying this Regulation unless disclosure is in the public interest. Competent national authorities and the Commission may exchange confidential information between themselves only with prior agreement of the originating authority. These obligations do not restrict rights to exchange warnings or provide information under criminal law, nor do they prevent the Commission and Member States from sharing confidential information with third country authorities under bilateral or multilateral confidentiality agreements.

Article 50 Penalties

Member States must establish penalty rules for breaches by economic operators and ensure implementation; penalties must be competent, fair and deterrent, and may comprise criminal penalties for serious breaches. Member States must notify the Commission by 14 October 2026 of their penalty rules and any later amendments.

Article 51 Repeals

Directive 73/361/EEC is repealed with references to it now referring to this Regulation. Directive 2006/42/EC is repealed effective from 14 January 2027, with references updated to this Regulation and interpreted according to the correlation table in Annex XII.

Article 52 Transitional provisions

Products placed on the market under Directive 2006/42/EC prior to 14 January 2027 may continue to be marketed, but shall comply with Chapter VI of this Regulation instead of that Directive's Article 11 from 13 July 2023. Type-examination certificates and approvals issued under that Directive's Article 12 remain valid until expiry.

Article 53 Evaluation and review

Article 54 Entry into force and application

Lists nineteen categories of machinery and related products subject to this regulation, including sawing machinery with various fixed and movable blade configurations for wood and meat processing, hand-fed woodworking machinery, metal presses with travel exceeding 6 mm and speed exceeding 30 mm/s, plastics and rubber moulding machinery, underground mining equipment, refuse trucks with compression mechanisms, lifting devices involving a fall risk exceeding 3 m, and protective structures or safety components.