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

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 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 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 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 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 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.

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 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 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'.