Machinery Regulation obligations

Who. Manufacturers, importers and distributors deciding whether the Regulation applies to their product

• Check whether the product is machinery, one of the five related products or partly completed machinery (Art. 2(1))
• Check the exclusions of Art. 2(2) before applying the Regulation, in particular the electrical products covered by the Low Voltage Directive or the Radio Equipment Directive

Who. Member States; economic operators exhibiting or demonstrating products

• Show a non-compliant product at a trade fair, exhibition or demonstration only with a visible sign that it does not comply and will not be made available on the market until it has been brought into conformity (Art. 4(2))
• Take adequate measures to protect persons during demonstrations (Art. 4(2))

Who. Manufacturers of machinery or related products in the categories of Annex I; the Commission and the Member States for the list itself

• Apply a conformity assessment procedure of Art. 25(2) to machinery or related products in a category of Annex I, Part A (Art. 6(1))
• Apply a conformity assessment procedure of Art. 25(3) to machinery or related products in a category of Annex I, Part B (Art. 6(1))
• Member States: provide the accident, market surveillance and close-call data of Art. 6(5) for every Annex I category by 20 July 2025 and every five years thereafter (Art. 6(9))
• Member States: inform the Commission with reasons of concerns about a category being listed or not listed in Annex I (Art. 6(8))

Who. Manufacturers of safety components, including software that fulfils a safety function

• Treat the components listed in Annex II as safety components, and assess unlisted components against the definition of Art. 3(3) because the list is only indicative (Art. 7(1))

Who. All economic operators making machinery, related products or partly completed machinery available on the market or putting them into service

• Make machinery or a related product available or put it into service only if, properly installed and maintained and used as intended or under reasonably foreseeable conditions, it meets the essential health and safety requirements of Annex III (Art. 8)
• Make partly completed machinery available only if it meets the relevant essential health and safety requirements of Annex III (Art. 8)

Who. Manufacturers of products that also fall under more specific Union product legislation

• Identify more specific Union harmonisation legislation that covers risks addressed by Annex III for the product, and apply the Machinery Regulation only to the risks that legislation does not cover (Art. 9)

Who. Manufacturers choosing how to demonstrate conformity; the Commission and the standardisation organisations

• Conformity with harmonised standards published in the Official Journal gives a presumption of conformity with the requirements of Annex III they cover (Art. 20(1))
• Conformity with common specifications adopted by the Commission gives the same presumption; they are repealed once a harmonised standard covers the requirement (Art. 20(6) and (7))
• A cybersecurity certificate or statement of conformity under a scheme of Regulation (EU) 2019/881 with published references gives a presumption of conformity with Annex III sections 1.1.9 and 1.2.1, as far as the certificate covers them (Art. 20(9))

Who. Manufacturers of machinery and related products, and their authorised representatives where the mandate allows

• State in the EU declaration of conformity that the fulfilment of the applicable essential health and safety requirements of Annex III has been demonstrated (Art. 21(1))
• Use the model of Annex V, Part A with the elements of the module applied (Annexes VI, VIII, IX and X), keep the declaration continuously updated and translate it into the languages required by the Member State where the product is made available or put into service (Art. 21(2))
• Draw up a single EU declaration of conformity for all Union acts that require one, identifying each act and its publication reference (Art. 21(3))
• By drawing up the declaration, assume responsibility for the compliance of the machinery or related product (Art. 21(4))

Who. Manufacturers of partly completed machinery

• State in the EU declaration of incorporation that the fulfilment of the relevant essential health and safety requirements of Annex III has been demonstrated (Art. 22(1))
• Use the model of Annex V, Part B, keep the declaration continually updated and translate it into the languages required by the Member State where the partly completed machinery is placed or made available on the market (Art. 22(2))
• Where other Union acts requiring an EU declaration of conformity apply, include a sentence declaring conformity with them and identify those acts with their publication references (Art. 22(3))
• By drawing up the declaration, assume responsibility for the compliance of the partly completed machinery (Art. 22(4))

Who. Manufacturers and authorised representatives affixing the CE marking

• Apply the general principles for the CE marking of Art. 30 of Regulation (EC) No 765/2008 (Art. 23)

Who. Manufacturers of machinery and related products and their authorised representatives; Member States for enforcement of the marking regime

• Affix the CE marking visibly, legibly and indelibly to the machinery or related product, or where that is not possible or not warranted, to its packaging and accompanying documents (Art. 24(1))
• Affix the CE marking before the product is placed on the market or put into service (Art. 24(2))
• Where the procedure involved a notified body under Art. 25(2)(a) to (c) or Art. 25(3)(b) to (d), follow the CE marking with the identification number of that body, affixed by the body or under its instructions (Art. 24(3))
• Any pictogram or other marking indicating a special risk or use comes after the CE marking and the notified body number (Art. 24(4))

Who. Member States

• Member States: notify the Commission and the other Member States of the bodies authorised to carry out third-party conformity assessment tasks under the Regulation (Art. 26)

Who. Member States and their notifying authorities

• Member States: designate a notifying authority responsible for assessing, notifying and monitoring conformity assessment bodies, including compliance with Art. 32 (Art. 27(1))
• A non-governmental body entrusted with these tasks must be a legal entity, comply with Art. 28 and have arrangements covering its liabilities; the notifying authority keeps full responsibility (Art. 27(3) and (4))

Who. Notifying authorities of the Member States

• Notifying authorities: be established without conflicts of interest with conformity assessment bodies and operate objectively and impartially (Art. 28(1) and (2))
• Notifying authorities: have notification decisions taken by competent persons other than those who carried out the assessment (Art. 28(3))
• Notifying authorities: do not offer conformity assessment activities or commercial consultancy, safeguard confidentiality and keep sufficient competent personnel (Art. 28(4) to (6))

Who. Member States; the Commission publishes the information

• Member States: inform the Commission of the procedures for assessing and notifying conformity assessment bodies and for monitoring notified bodies, and of any changes (Art. 29)

Who. Conformity assessment bodies applying for notification and notified bodies

• Be established under the national law of a Member State with legal personality, as a third-party body independent of the organisation and the machinery or related products it assesses (Art. 30(2) and (3))
• Keep management and assessment personnel out of the design, manufacture, supply, installation, use, maintenance and marketing of the products assessed and out of consultancy on them, and ensure subsidiaries and subcontractors do not affect confidentiality, objectivity or impartiality (Art. 30(4))
• Carry out conformity assessment with professional integrity and technical competence, free from pressures and inducements, particularly financial (Art. 30(5))
• Have the personnel, documented procedures, separation of notified from other activities, and means and equipment for every procedure of Annexes VII, IX and X and every kind of product notified for, taking account of the size and structure of the undertaking and the complexity and production mode of the product (Art. 30(6))
• Ensure assessment personnel have sound training, knowledge of Annex III and the applicable harmonised standards and common specifications, adequate authority, and the ability to draw up certificates, records and reports (Art. 30(7))
• Guarantee impartiality; remuneration of management and assessment personnel may not depend on the number or results of assessments (Art. 30(8))

and 3 more in the full text

Who. Conformity assessment bodies and notifying authorities

• Conformity assessment bodies: demonstrate conformity with the relevant harmonised standards to be presumed to meet the requirements of Art. 30 they cover (Art. 31)

Who. Notified bodies using subcontractors or subsidiaries

• Notified bodies: ensure subcontractors and subsidiaries meet the requirements of Art. 30 and inform the notifying authority (Art. 32(1))
• Notified bodies: take full responsibility for the tasks performed by subcontractors or subsidiaries wherever they are established (Art. 32(2))
• Notified bodies: subcontract or use a subsidiary only with the agreement of the client (Art. 32(3))
• Notified bodies: keep the documents on the assessment of the qualifications of subcontractors and subsidiaries and on their work under Annexes VII, IX and X at the disposal of the notifying authority (Art. 32(4))

Who. Conformity assessment bodies seeking notification

• Conformity assessment bodies: apply for notification to the notifying authority of the Member State of establishment (Art. 33(1))
• Conformity assessment bodies: describe in the application the conformity assessment activities, the procedures of Annexes VII, IX and X and the kinds or categories of machinery or related products claimed, with an accreditation certificate where one exists (Art. 33(2))
• Conformity assessment bodies without an accreditation certificate: provide all documentary evidence needed for verification, recognition and regular monitoring of compliance with Art. 30 (Art. 33(3))

Who. Notifying authorities and conformity assessment bodies

• Notifying authorities: notify only conformity assessment bodies that satisfy Art. 30, through the Commission's electronic notification tool, with full details of the activities, modules, product categories and attestation of competence (Art. 34(1) to (3))
• Notifying authorities: where the notification is not based on accreditation, provide documentary evidence of the body's competence and of the arrangements for its regular monitoring (Art. 34(4))
• A body acts as a notified body only if no objection is raised within two weeks of validation (with accreditation certificate) or two months (with documentary evidence) (Art. 34(5))
• Notifying authorities: notify the Commission and the other Member States of subsequent relevant changes to the notification (Art. 34(6))

Who. The Commission; manufacturers use the list to find a notified body and its number for the CE marking

• The Commission assigns one identification number per notified body and publishes the up-to-date list of bodies notified under the Regulation with their numbers and activities (Art. 35)

Who. Notifying authorities; notified bodies whose notification changes

• Notifying authorities: restrict, suspend or withdraw the notification of a body that no longer meets Art. 30 or fails its obligations under Art. 38, and immediately inform the Commission and the other Member States (Art. 36(1))
• Notifying authorities: after restriction, suspension, withdrawal or cessation, ensure the body's files are processed by another notified body or kept available for the notifying and market surveillance authorities (Art. 36(2))

Who. The Commission and the notifying Member States

• Notifying Member States: provide the Commission on request with all information on the basis for the notification or the maintenance of the body's competence (Art. 37(2))
• Member States: take the corrective measures the Commission requests by implementing act, including withdrawal of the notification if necessary (Art. 37(4))

Who. Notified bodies

• Notified bodies: carry out conformity assessments in accordance with the procedures of Annexes VII, IX and X (Art. 38(1))
• Notified bodies: work proportionately, avoiding unnecessary burdens and taking account of the size, sector and structure of the undertaking, the complexity of the technology and the production mode, while respecting the rigour and level of protection required (Art. 38(2))
• Notified bodies: where Annex III or the corresponding standards or common specifications are not met, require corrective action and do not issue an EU type-examination certificate, quality system approval or unit verification certificate (Art. 38(3))
• Notified bodies: where monitoring under Annex IX shows a product no longer complies, require corrective action and suspend or withdraw the approval decision if necessary; restrict, suspend or withdraw approvals when corrective action is not taken or fails (Art. 38(4))

Who. Notified bodies; manufacturers who disagree with a decision

• Notified bodies: ensure a transparent and accessible appeals procedure against their decisions is available (Art. 39)

Who. Notified bodies

• Notified bodies: inform the notifying authority of any refusal, restriction, suspension or withdrawal of an EU type-examination certificate, quality system approval or unit verification certificate (Art. 40(1)(a))
• Notified bodies: inform the notifying authority of circumstances affecting the scope or conditions of the notification, of information requests from market surveillance authorities and, on request, of all assessment activities including cross-border activities and subcontracting (Art. 40(1)(b) to (d))
• Notified bodies: provide other notified bodies doing similar assessments of the same kinds of products with information on negative results and, on request, positive results (Art. 40(2))

Who. Notified bodies and the Commission

• Notified bodies: participate in the work of the sectoral group of notified bodies, directly or through designated representatives (Art. 42)

Who. All parties carrying out tasks under the Regulation: authorities, the Commission, notified bodies

• Respect the confidentiality of personal data and of commercially confidential information and trade secrets, including intellectual property rights, obtained in carrying out tasks under the Regulation, unless disclosure is in the public interest (Art. 49(1))
• Do not disclose information exchanged on a confidential basis between competent national authorities or with the Commission without the prior agreement of the authority that provided it (Art. 49(2))

Who. Member States; economic operators are subject to the national penalties

• Member States: lay down rules on penalties for infringements by economic operators that are effective, proportionate and dissuasive, possibly including criminal penalties for serious infringements, and ensure they are implemented (Art. 50(1))
• Member States: notify the penalty rules and measures to the Commission by 20 October 2026 and any subsequent amendment without delay (Art. 50(2))

Who. Manufacturers of the listed categories, including developers of machine-learning based safety functions and of logic units ensuring safety functions

• Machinery or a safety component in a Part A category, including machine-learning safety components and embedded self-evolving safety systems, must go through EU type-examination with conformity to type, full quality assurance or unit verification (Art. 25(2))
• Machinery in a Part B category may use internal production control only when designed and constructed to harmonised standards or common specifications specific to that category covering all relevant requirements; otherwise a notified body route applies (Art. 25(3))

Who. Manufacturers of components that fulfil a safety function and are placed on the market independently

• Treat software ensuring safety functions (point 18) and machine-learning safety components (point 19) placed on the market independently as safety components with the full manufacturer obligations of Art. 10 (Annex II)

Who. Manufacturers of machinery and related products; manufacturers of partly completed machinery for the requirements relevant to them (section 1.1.1); persons carrying out a substantial modification (Art. 18)

• Carry out an iterative risk assessment: determine the limits including intended use and reasonably foreseeable misuse, identify hazards, estimate and evaluate risks, and eliminate or reduce them in the order of priority of section 1.1.2(b) (Part B, point 1)
• Include in the risk assessment the hazards that may arise during the lifecycle from foreseeable self-evolving behaviour or logic of machinery operating with varying levels of autonomy, and the risks from interactions between machinery that functions as an integral whole (Part B, point 1)
• Apply the principles of safety integration in all cases: inherently safe design and construction first, then protective measures for risks that cannot be eliminated, then information to users on residual risks, training and personal protective equipment (section 1.1.2)
• Design so that connecting another device, or a remote device communicating with the machinery, cannot lead to a hazardous situation (section 1.1.9)
• Protect hardware that transmits signals or data for connection to or access to safety-critical software against accidental or intentional corruption, and collect evidence of legitimate or illegitimate interventions in that hardware (section 1.1.9)
• Identify the software and data critical for compliance with the essential health and safety requirements and protect them against accidental or intentional corruption (section 1.1.9)

and 11 more in the full text

Who. Manufacturers of machinery, related products and partly completed machinery (Art. 10(2), 11(2)); importers must be able to make it available (Art. 13(8), 14(7))

• Document a complete description of the machinery or related product and its intended use (Part A (a))
• Document the risk assessment procedure: the list of applicable essential health and safety requirements and the protective measures implemented for each, with the residual risks where appropriate (Part A (b))
• Include the design and manufacturing drawings, schemes and the descriptions and explanations needed to understand them and the operation of the product (Part A (c) and (d))
• List the harmonised standards or common specifications applied, stating which parts where application is partial, and describe the other technical specifications applied where they were not used (Part A (e) and (f))
• Include the reports and results of design calculations, tests, inspections and examinations that verify conformity with the applicable requirements (Part A (g))
• Describe the means used during production to ensure the products conform to the design specifications, and for series production the internal measures to keep them in conformity (Part A (h) and (l))

and 5 more in the full text

Who. Manufacturers of machinery and related products (Part A) and of partly completed machinery (Part B)

• Draw up the EU declaration of conformity with all the particulars of Part A: product identification, manufacturer and authorised representative, sole responsibility, object, Union legislation, standards or common specifications applied with dates, notified body and certificate or the statement that module A applied, and signature (Annex V, Part A)
• Draw up the EU declaration of incorporation with all the particulars of Part B, including the sentence on which requirements of Annex III are applied and fulfilled, the undertaking to transmit information to national authorities on a reasoned request, and the statement that the partly completed machinery is not to be put into service until the final machinery has been declared in conformity (Annex V, Part B)

Who. Manufacturers of machinery not listed in Annex I, and of Annex I Part B machinery designed to fully covering harmonised standards or common specifications (Art. 25(3) and (4))

• Draw up the technical documentation described in Annex IV, Part A (Annex VI, point 2)
• Take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured products with the technical documentation and the applicable requirements (Annex VI, point 3)
• Affix the CE marking to each machinery or related product that satisfies the applicable requirements (Annex VI, point 4.1)
• Draw up an EU declaration of conformity for each product model and keep it with the technical documentation at the disposal of the national authorities for at least 10 years, providing a copy on request (Annex VI, point 4.2)

Who. Manufacturers of Annex I machinery using the route of Art. 25(2)(a) or 25(3)(b); notified bodies

• Lodge the application for EU type-examination with a single notified body of your choice, with a written declaration that the same application has not been lodged with another body, the technical documentation of Annex IV Part A and access to representative specimens (Annex VII, point 3)
• Inform the notified body holding the technical documentation of all modifications to the approved type and to the documentation that may affect conformity or the conditions of the certificate; such modifications need an addition to the certificate (Annex VII, point 7.2)
• Ensure the machinery or related product continues to fulfil the applicable requirements in the light of the state of the art (Annex VII, point 7.3)
• Ask the notified body to review the certificate after a modification to the type, after a change in the state of the art, and at the latest before the expiry date; apply for renewal between 12 and 6 months before expiry, otherwise the review can only lead to an addition with the original expiry date (Annex VII, point 7.4)
• Stop placing the product on the market when the notified body withdraws the EU type-examination certificate (Annex VII, point 7.7)
• Keep a copy of the EU type-examination certificate, its annexes and additions with the technical documentation at the disposal of the national authorities for at least 10 years (Annex VII, point 9)

and 1 more in the full text

Who. Manufacturers of Annex I machinery following EU type-examination (Art. 25(2)(a), 25(3)(b))

• Take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the products with the type described in the EU type-examination certificate and with the applicable requirements (Annex VIII, point 2)
• Affix the CE marking to all products that conform to the approved type and satisfy the applicable requirements (Annex VIII, point 3.1)
• Draw up an EU declaration of conformity for the product model and keep it at the disposal of the national authorities for at least 10 years, providing a copy on request (Annex VIII, point 3.2)

Who. Manufacturers of Annex I machinery choosing the route of Art. 25(2)(b) or 25(3)(c); notified bodies

• Operate an approved quality system for design, manufacture and final product inspection and testing of the machinery or related products concerned, subject to surveillance by the notified body (Annex IX, point 2)
• Apply to a single notified body with the technical documentation of Annex IV Part A for one model per category, the quality system documentation and a declaration that no other body has the same application (Annex IX, point 3.1)
• Document the quality system systematically: quality objectives and organisation, design specifications and standards applied, design control and verification techniques, manufacturing and quality assurance techniques, examinations and tests and their frequency, quality records, and the monitoring of design and product quality (Annex IX, point 3.2)
• Fulfil the obligations of the approved quality system, maintain it so that it remains adequate and efficient, and inform the notified body of any intended change for evaluation (Annex IX, points 3.4 and 3.5)
• Give the notified body access to the design, manufacturing, inspection, testing and storage sites and to the quality system documentation and records for periodic audits and unexpected visits (Annex IX, point 4)
• Affix the CE marking and, under the notified body's responsibility, its identification number to each product that satisfies the applicable requirements (Annex IX, point 5.1)

and 2 more in the full text

Who. Manufacturers of Annex I machinery produced as single units choosing the route of Art. 25(2)(c) or 25(3)(d); notified bodies

• Establish technical documentation that allows the notified body to assess the unit's conformity with Annex III, including an adequate analysis and assessment of the risks, the elements of Annex IV Part A points (a) to (g), the quality system documentation where applicable and a declaration that the application has not been lodged with another body, and keep it for at least 10 years (Annex X, point 2)
• Take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the unit with the applicable requirements of Annex III (Annex X, point 3)
• Have a notified body of your choice carry out the examinations and tests of the relevant harmonised standards or common specifications, or equivalent tests, issue a certificate and affix its identification number; keep the certificates for at least 10 years (Annex X, point 4)
• Affix the CE marking and, under the notified body's responsibility, its identification number, draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for at least 10 years (Annex X, point 5)

Who. Manufacturers of partly completed machinery (Art. 11(7)); importers and distributors check that the instructions accompany the product (Art. 14(4), 16(2))

• Describe in the assembly instructions the conditions to be met for correct incorporation so that the final machinery does not compromise the health and safety of persons and, where appropriate, domestic animals, property and the environment (Annex XI, point 1)
• Include the information of point 2 (a) to (n): general description, drawings and diagrams, warnings on misuse, assembly, installation and connection instructions, noise and vibration information, the applicable requirements of Annex III, tool characteristics, stability conditions, safe transport and storage with masses, procedures for accidents and blockages, adjustment and maintenance, safe maintenance measures, safety-relevant spare parts and the version of the instructions (Annex XI, point 2)
• Where the partly completed machinery is intended for machinery covered by chapters 2 to 6 of Annex III, include the relevant information for the instructions for use of that machinery (Annex XI, point 2)
• Include the EU declaration of incorporation, or the internet address or machine-readable code where it can be accessed (Annex XI, point 3)