EU Machinery Regulation (Regulation (EU) 2023/1230)

Article 10 imposes the central manufacturer obligations: (a) ensure the EHSR Annex III compliance + carry out risk assessment per Annex III 1; (b) draw up the technical documentation per Annex IV + retain for 10 years; (c) carry out the applicable conformity assessment procedure (Article 25); (d) draw up the EU declaration of conformity (Article 21); (e) affix the CE marking (Article 23-24); (f) provide instructions and information per Annex III 1.7; (g) Article 10(7) provide digital or paper instructions (digital permitted; consumer can request paper); (h) Article 10(8) substantial-modification rule (operator that makes a substantial modification becomes responsible for compliance); (i) Article 10(9) corrective action obligation; (j) Article 10(10) cooperate with market surveillance.

Article 11 imposes obligations on manufacturers of partly completed machinery: prepare technical documentation per Annex VII Part B, draw up an Article 22 EU declaration of incorporation, provide assembly instructions per Annex XI. Partly completed machinery is not CE-marked (it is not a finished product) but is supplied with a declaration of incorporation that allows the final assembler to incorporate it into a complete machine. Article 22 sets the content of the EU declaration of incorporation.

Article 12 requires a non-EU manufacturer to designate, by written mandate, an authorised representative established in the Union, with Article 12(3) tasks (keep EU DoC + technical documentation for 10 years + cooperation with MSA). Articles 13-14 set importer obligations for machinery and partly completed machinery (verify manufacturer's conformity assessment + CE marking + EU DoC + identification + instructions + Article 13(7) corrective action). Articles 15-16 set distributor obligations for machinery and partly completed machinery (due care + verification + cooperation).

Article 17 provides that an importer or distributor is considered to be the manufacturer + subject to Article 10 obligations where the importer / distributor places a machinery / related product / partly completed machinery on the market under its own name or trademark, or modifies a product already placed on the market in such a way that compliance may be affected. Article 18 covers other cases where the manufacturer-equivalent obligations apply (substantial-modification operator under Article 10(8)). Article 19 requires economic operators to identify, on request of MSA, any other economic operator that supplied them with the product or to whom they have supplied the product, for 10 years.

Article 1 sets the subject matter: health and safety requirements for the design and construction of machinery, related products and partly completed machinery, the rules on placing them on the market or putting them into service. Article 2 sets the scope (machinery as defined; sectoral carve-outs for medical devices, motor vehicles, ATEX equipment etc.). Article 3 supplies definitions including 'machinery' (assembled with linked parts/components, at least one of which moves), 'related product' (interchangeable equipment, safety component, lifting accessory, chain/rope/webbing, removable mechanical transmission device, partly completed machinery), 'safety component', 'partly completed machinery', 'substantial modification', 'machinery with self-evolving behaviour', 'high-risk machinery'.

Article 20 establishes the presumption of conformity: machinery and related products in conformity with harmonised standards or parts thereof referenced in the OJ, or with common specifications adopted by the Commission, are presumed in conformity with the EHSR covered by those standards / specifications. The presumption is sectoral by EHSR clause.

Article 21 requires the manufacturer to draw up the EU declaration of conformity per Annex V before placing on the market or putting into service. By drawing up the EU DoC the manufacturer assumes responsibility for compliance. The EU DoC is kept for 10 years. Article 22 sets the EU declaration of incorporation for partly completed machinery (Annex XI Part B).

Article 23 applies the general principles of the CE marking per Regulation (EC) 765/2008 to machinery. Article 24 sets the affixing rules: CE marking visible, legible, indelible, affixed before placing on the market; for high-risk products subject to Annex I requiring notified-body assessment, the NB identification number follows the CE marking. Partly completed machinery is NOT CE-marked.

Article 25 sets the conformity assessment routes. (1) Default (non-Annex-I): manufacturer self-assessment via Annex VIII (internal production control) + Annex IV technical documentation. (2) Annex I high-risk products: mandatory third-party involvement. The manufacturer chooses among Annex IX (EU type-examination + production-quality assurance), Annex X (full quality assurance) or Annex XI (third-party verification) routes. For Annex I (Class A) products where the manufacturer applies harmonised standards covering all EHSR, the Annex VIII self-assessment route remains available; for Annex I (Class B), one of Annex IX/X/XI is mandatory regardless. (3) Specific paths for safety components.

Article 26 requires Member States to notify the Commission and the other Member States of bodies authorised to carry out third-party conformity-assessment tasks under the Regulation. Article 27 sets the requirements for notifying authorities. Article 28 sets the substantive requirements for notifying authorities (legally distinct from operators, no conflict of interest, sufficient resources).

Article 30 sets the substantive requirements for notified bodies (independence, competence, accreditation by the national accreditation body, professional liability insurance, no conflicts of interest). Article 31 sets the presumption of conformity for NBs that demonstrate conformity with the harmonised standards. Article 32 governs subcontracting + subsidiaries (NB retains full responsibility). Article 38 sets the operational obligations of NBs (impartiality, transparency, fees, ongoing competence).

Article 43 sets the procedure at national level: where a market surveillance authority has sufficient reason to believe that a product within the scope presents a risk, it carries out an evaluation and may require corrective action / withdrawal / recall. Article 44 sets the Union safeguard procedure for cases where Member States disagree on the existence of the risk or the measure taken; the Commission decides by implementing act.

Article 45 allows MSA action against products that comply formally with the Regulation but still present a risk to health, safety or other public interests. Article 46 covers formal non-compliance (e.g. CE marking incorrectly affixed, EU DoC missing, technical documentation absent or incomplete) which triggers MSA action separate from substantive risk-based action.

Article 47 governs the exercise of the delegation of power to the Commission (Annex I updates, Annex III adaptations). Article 48 sets the committee procedure (the Machinery Committee).

Article 49 imposes professional-secrecy obligations on all parties involved in the application of the Regulation. Information acquired may only be used for the purposes for which it was acquired, with carve-outs for cooperation between authorities and for publication of MSA decisions.

Article 4 ensures free movement: Member States shall not impede the placing on the market / putting into service of products that comply with the Regulation. Trade fairs and demonstrations are permitted under safeguards. Article 5 enables Member States to take all appropriate measures to protect persons during installation or use of machinery / related products, with a presumption that products complying with the Regulation do not endanger health and safety.

Article 50 requires Member States to lay down rules on penalties applicable to infringements of the Regulation. Penalties shall be effective, proportionate and dissuasive. Member States notify the Commission of the rules by the application date. Maximum administrative-fine ceilings vary by Member State but typically up to 3-4% of the relevant economic operator's annual turnover for the most serious infringements (placing dangerous products on the market with knowledge).

Article 51 repeals Directive 2006/42/EC (the prior Machinery Directive) and Council Directive 73/361/EEC, both with effect from 20 January 2027. Article 52 sets transitional provisions: Member States shall not impede the placing on the market of products that comply with the prior Machinery Directive 2006/42/EC where they were placed on the market before 20 January 2027 (continued circulation of legacy stock). Article 53 requires the Commission to evaluate the Regulation by 14 January 2030 and every 7 years thereafter. Article 54 provides that the Regulation entered into force on 19 July 2023 and applies from 20 January 2027 (3.5-year transition).

Article 6 designates the high-risk machinery categories listed in Annex I that are subject to mandatory third-party conformity assessment (because of the level of risk). Annex I categories include circular saws, hand-fed surface planing machines, woodworking thicknessing machines, band-saw machines, chain saws, portable cartridge-operated fixing tools, vehicle servicing lifts, devices to lift persons or persons and goods, removable mechanical transmission devices, AND - critically - safety components incorporating fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions (the AI-safety category). Article 7 defines safety components and brings them within the Regulation scope.

Article 8 imposes the central requirement: machinery and related products placed on the market or put into service shall comply with the essential health and safety requirements (EHSR) set out in Annex III. Annex III covers: 1.1 general principles of safety integration (eliminate / reduce / inform), 1.1.9 protection against corruption (cybersecurity-as-safety: machinery must not allow unauthorised connections / software modifications that compromise safety), 1.2 safety + reliability of control systems including 1.2.1 reliability of safety-related parts of control systems and the new 1.2.6 AI / autonomous-behaviour safety provisions, 1.3 protection against mechanical hazards, 1.4 guards + protective devices, 1.5 risks due to other hazards, 1.6 maintenance, 1.7 information / instructions for use (digital instructions permitted under Annex III 1.7), 2-6 specific requirements for foodstuff / portable / lifting / underground / persons-lifting machinery. Article 9 coordinates with sectoral Union harmonisation legislation: where a sectoral act covers some EHSR for a product, that act applies for those aspects and the Machinery Regulation continues to apply for the remaining aspects.