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Framework

Machinery Regulation (EU) 2023/1230

From 20 January 2027 the Machinery Regulation replaces the Machinery Directive and requires protection against corruption and safe control systems for the first time. Complass guides you to CE marking.

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What is Machinery Regulation?

The Machinery Regulation (EU) 2023/1230 sets the health and safety requirements for machinery and replaces the Machinery Directive 2006/42/EC from 20 January 2027. New are, among others, requirements for protection against corruption (Annex III section 1.1.9) and for safe and reliable control systems (section 1.2.1).

Content as of:

Does it apply to me?

The regulation applies to machinery, related products and partly completed machinery placed on the market or put into service in the EU. Obligations affect manufacturers, importers and distributors. Anyone who substantially modifies a machine may be considered a manufacturer, which also affects operators and integrators.

This overview does not replace legal advice. The legal or normative text is authoritative; in Complass you check applicability with guidance based on the references.

Legal basis

  • Art. 2 MaschinenVOArticle 2 Machinery Regulation Scope1. 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 …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗Scope
  • Art. 3 MaschinenVOArticle 3 Machinery Regulation DefinitionsFor 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 …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗Definitions, including substantial modification
  • Anhang III Abschn. 1.1.9Annex III Section 1.1.9 Machinery Regulation Protection against corruptionThe machinery or related product shall be designed and constructed so that the connection to it of another device, via any feature of the connected device itself or via any remote device that communicates with the machinery or related product does not lead to a hazardous situation. A hardware component transmitting signal or data, relevant for connection or access to software that is critical for the compliance of …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗Protection against corruption
  • Anhang III Abschn. 1.2.1Annex III Section 1.2.1 Machinery Regulation Safety and reliability of control systemsControl systems shall be designed and constructed in such a way as to prevent hazardous situations from arising. Control systems shall be designed and constructed in such a way that: - (a) they can withstand, where appropriate to the circumstances and the risks, the intended operating stresses and intended and unintended external influences, including reasonably foreseeable malicious attempts from third parties …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗Safety and reliability of control systems

Key dates

  1. Entry into force of the Regulation; Art. 6(7), Art. 48 and Art. 52 apply (market surveillance under Chapter VI also for products under the Machinery Directive) · Art. 54(1), (3)(c)Article 54 Machinery Regulation Entry into force and applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 20 January 2027. However, the following Articles shall apply from the following dates: - (a) Articles 26 to 42 from 20 January 2024; - (b) Article 50(1) from 20 October 2026; - (c) Article 6(7) and Articles 48 and 52 from 19 July 2023; - (d) Article 6(2) to …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  2. Rules on the notification of conformity assessment bodies (Art. 26–42) apply · Art. 54(3)(a)Article 54 Machinery Regulation Entry into force and applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 20 January 2027. However, the following Articles shall apply from the following dates: - (a) Articles 26 to 42 from 20 January 2024; - (b) Article 50(1) from 20 October 2026; - (c) Article 6(7) and Articles 48 and 52 from 19 July 2023; - (d) Article 6(2) to …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  3. Art. 6(2)–(6), (8) and (11), Art. 47 and Art. 53(3) apply · Art. 54(3)(d)Article 54 Machinery Regulation Entry into force and applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 20 January 2027. However, the following Articles shall apply from the following dates: - (a) Articles 26 to 42 from 20 January 2024; - (b) Article 50(1) from 20 October 2026; - (c) Article 6(7) and Articles 48 and 52 from 19 July 2023; - (d) Article 6(2) to …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  4. Emergency procedures under Chapter IVa (Art. 25a to 25e, inserted by Regulation (EU) 2024/2748) apply · Art. 25a; Art. 7 Regulation (EU) 2024/2748Article 25a Machinery Regulation Application of emergency procedures1. Articles 25b to 25e of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to machinery and related products covered by this Regulation. 2. Articles 25b to 25e of this Regulation shall apply only to machinery and related products which have been designated as crisis-relevant goods pursuant to Article 18(4) of …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  5. Digital Omnibus on AI in force: empowerment for AI requirements in Annex III, presumption of conformity via AI standards · Art. 8, third paragraph, Art. 20(10), Art. 47(2)Article 8 Machinery Regulation Essential health and safety requirements for products within the scope of this RegulationMachinery 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 …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  6. Member State rules on penalties (Art. 50(1)) apply · Art. 54(3)(b)Article 54 Machinery Regulation Entry into force and applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 20 January 2027. However, the following Articles shall apply from the following dates: - (a) Articles 26 to 42 from 20 January 2024; - (b) Article 50(1) from 20 October 2026; - (c) Article 6(7) and Articles 48 and 52 from 19 July 2023; - (d) Article 6(2) to …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  7. Date of application of the Regulation, repeal of Machinery Directive 2006/42/EC · Art. 54(2), Art. 51(2)Article 54 Machinery Regulation Entry into force and applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 20 January 2027. However, the following Articles shall apply from the following dates: - (a) Articles 26 to 42 from 20 January 2024; - (b) Article 50(1) from 20 October 2026; - (c) Article 6(7) and Articles 48 and 52 from 19 July 2023; - (d) Article 6(2) to …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗
  8. AI requirements in Annex III for AI safety components that are high-risk AI systems apply (delegated acts) · Art. 8, fourth paragraphArticle 8 Machinery Regulation Essential health and safety requirements for products within the scope of this RegulationMachinery 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 …As of: 06.10.2026 · Source: EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026Open original (EUR-Lex – OJ L 165, 29.6.2023; Art. 3, 8, 20, 25a–25e and 47 as consolidated on 27.07.2026) ↗

How Complass helps

  • 9phases
  • 31guided steps
  • 11document templates
  • 40requirements in the catalogue

  • Nine phases to CE marking

    Scope and role, classification and choice of procedure, risk assessment, cybersecurity, presumption of conformity, technical documentation and post-market obligations.

  • Catalogue Annex III with cyber relevance

    Requirements with cyber relevance and formal obligations with status and evidence, linkable with the CRA and IEC 62443.

  • Templates

    Including assessment of a substantial modification, threat analysis, evidence for 1.1.9 and 1.2.1, software and update concept, operating instructions on cybersecurity, EU declaration of conformity and of incorporation.

The phases in the module

  1. Scope, role and timeline
  2. Classification and choice of conformity assessment procedure
  3. Risk assessment under Annex III
  4. Cybersecurity I: protection against corruption (Annex III section 1.1.9)
  5. Cybersecurity II: safety and reliability of control systems (Annex III section 1.2.1)
  6. Presumption of conformity and interplay with the CRA and IEC 62443
  7. Technical documentation, instructions for use and marking
  8. Conformity assessment, EU declaration of conformity and CE marking
  9. Post-market obligations and market surveillance

Catalogue: Requirement catalogue – Annex III with cyber relevance and formal obligations

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Machinery Regulation in Complass: what you need at a minimum

The first selection covers the obligations in Complass if they apply to you. The free applicability check shows whether they do. To the applicability check

What you need at a minimum

If the Machinery Regulation applies to you: this selection covers the resulting obligations in Complass. It is preselected when you start a trial or order.

Portal size Start

Price of the minimum selection
ItemNet price per month
Start S€179
Machinery Regulationincluded
GDPR, AI Act and Whistleblower protection (HinSchG) (baseline protection)included
Total€179 net/month

With annual payment, 12 months minimum term. Monthly payment with a 15 % surcharge. All prices net plus VAT, as of 16 October 2026.

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Business with Asset management and zones

More impact with Asset management and zones, Risk management and Business continuity management (BCM), room for 10 users and 2 frameworks.

€548 net/month, €369 more than the minimum selection.

With annual payment, 12 months minimum term. Monthly payment with a 15 % surcharge. All prices net plus VAT, as of 16 October 2026.

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Good to know: You can also meet the obligations without Complass. Complass supports you with implementation and evidence but does not replace legal advice. Legal information

Frequently asked questions

We are an operator and modify plants. Does the regulation concern us?

Possibly, if the modification counts as substantial. The module contains a dedicated assessment with a template for this.

How are the Machinery Regulation and the CRA related?

One phase in the module deals with the interplay between the Machinery Regulation, the CRA and IEC 62443; the catalogues can be linked.

Does the AI Act also apply to AI in machinery?

For AI safety components that are high-risk AI systems, only a few articles of the AI Act have applied since 27 July 2026; their requirements will come through Annex III of the Machinery Regulation from 2 August 2028. AI functions without a safety role, such as wear prediction, must still be assessed under the general rules of the AI Act. The module guides you through the classification.

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