--- title: "EU Machinery Regulation (EU) 2023/1230" canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation" source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation" author: "Sorena AI" description: "A practical EU Machinery Regulation artifact grounded in Regulation (EU) 2023/1230 and its corrigendum: entry into force on 19 July 2023." published_at: "2026-02-21" updated_at: "2026-02-21" keywords: - "EU Machinery Regulation" - "Regulation (EU) 2023/1230" - "machinery regulation compliance" - "machinery regulation scope" - "Annex I Part A Part B" - "Article 25 conformity assessment" - "machinery CE marking" - "machinery regulation digital instructions" - "machinery regulation software logging" - "machinery regulation substantial modification" - "Annex IV technical documentation" - "essential health and safety requirements Annex III" - "Machinery Regulation" - "Annex I" - "Article 25" - "CE marking" --- **[SORENA](https://www.sorena.io/)** - AI-Powered GRC Platform [Home](https://www.sorena.io/) | [Solutions](https://www.sorena.io/solutions) | [Artifacts](https://www.sorena.io/artifacts) | [About Us](https://www.sorena.io/about-us) | [Contact](https://www.sorena.io/contact) | [Portal](https://app.sorena.io) --- # EU Machinery Regulation (EU) 2023/1230 A practical EU Machinery Regulation artifact grounded in Regulation (EU) 2023/1230 and its corrigendum: entry into force on 19 July 2023. ![EU Machinery Regulation artifact preview](https://cdn.sorena.io/cdn-cgi/image/format=auto/cheatsheets/prod/sorena-ai-eu-machinery-timeline-small.jpg?v=cheatsheets%2Fprod) *Machinery* *Free Resource* ## EU Machinery Regulation Timeline and Decision Flow Use this artifact to confirm whether your product is in scope for Regulation (EU) 2023/1230, identify the Annex I category, and map the conformity assessment route you need for CE marking and technical documentation. Grounded in the corrigendum to Regulation (EU) 2023/1230: entry into force on 19 July 2023, application from 14 January 2027, with earlier-applying provisions and specific digital-document and software-evidence duties. [Assess Machinery Regulation scope](/artifacts/eu/machinery-regulation/applicability-test.md) ## What you can decide faster - **Scope and exclusions**: Confirm if the Machinery Regulation applies to your product. - **Annex I classification**: Check whether your product falls under Annex I Part A or Part B. - **Conformity route**: Decide between Module A and a notified body route based on Article 25. Entry into force 19 Jul 2023 | Applies 14 Jan 2027 | Updated Mar 2026 ### Quick scan *Machinery* - **Scope**: Confirm if the regulation applies to your product. - **Assessment**: Map your Article 25 conformity assessment route. - **CE readiness**: Plan technical file and declarations early. Use the decision flow to connect product facts to scope, Annex I route, software evidence, and digital-document controls you can actually operate. | Value | Metric | | --- | --- | | 19 Jul 2023 | Entry | | 14 Jan 2027 | Applies | | Annex I | Route | | Annex IV | Evidence | **Key highlights:** Scope first | Annex I mapping | CE evidence ## Topic Guides - [Applicability Test | EU Machinery Regulation (EU) 2023/1230 | In Scope? Annex I? Article 25 Route?](/artifacts/eu/machinery-regulation/applicability-test.md): A step-by-step applicability test for EU Machinery Regulation (EU) 2023/1230: is it machinery / related product / partly completed machinery. - [Checklist | EU Machinery Regulation (EU) 2023/1230 | CE Marking Readiness Checklist (Route + Technical File + Declarations)](/artifacts/eu/machinery-regulation/checklist.md): An audit-ready CE marking checklist for EU Machinery Regulation (EU) 2023/1230: scope memo and exclusions (Article 2). - [Compliance Program | EU Machinery Regulation (EU) 2023/1230 | Operating Model, Controls, Transition to 2027](/artifacts/eu/machinery-regulation/compliance.md): Build a scalable compliance program for EU Machinery Regulation (EU) 2023/1230: product family strategy, scope and exclusions control. - [Conformity Assessment and CE Marking | EU Machinery Regulation (EU) 2023/1230 | Article 25 Modules, Annex I, DoC/DoI](/artifacts/eu/machinery-regulation/conformity-assessment-and-ce.md): A grounded guide to Article 25 conformity assessment under Regulation (EU) 2023/1230: Annex I Part A and Part B route selection, Module A versus B plus C, H. - [Deadlines and Compliance Calendar | EU Machinery Regulation (EU) 2023/1230 | Transition to 14 Jan 2027 + Route and Evidence Milestones](/artifacts/eu/machinery-regulation/deadlines-and-compliance-calendar.md): A grounded EU Machinery Regulation compliance calendar covering adoption on 14 June 2023, publication on 29 June 2023, entry into force on 19 July 2023. - [FAQ | EU Machinery Regulation (EU) 2023/1230 | Scope, Annex I, Article 25, Technical File, Software](/artifacts/eu/machinery-regulation/faq.md): High-signal FAQ for EU Machinery Regulation (EU) 2023/1230: what is in scope and excluded, how Annex I Part A/Part B changes the conformity assessment route. - [Machinery Regulation vs EU AI Act | Smart machinery, safety components, high-risk AI](/artifacts/eu/machinery-regulation/machinery-regulation-vs-eu-ai-act.md): A practical crosswalk for smart machinery: when the EU AI Act treats your AI as a high-risk safety component (Article 6). - [Machinery Regulation vs Machinery Directive | Regulation (EU) 2023/1230 vs Directive 2006/42/EC | Key Changes + Migration Plan](/artifacts/eu/machinery-regulation/machinery-regulation-vs-machinery-directive.md): A grounded comparison of Regulation (EU) 2023/1230 and Directive 2006/42/EC covering direct applicability, corrected transition dates. - [Penalties and Fines | EU Machinery Regulation (EU) 2023/1230 | Article 50, Enforcement, Corrective Actions](/artifacts/eu/machinery-regulation/penalties-and-fines.md): A practical enforcement guide for Regulation (EU) 2023/1230: Article 50 national penalties, the 14 October 2026 penalty-notification deadline. - [Requirements | EU Machinery Regulation (EU) 2023/1230 | EHSR (Annex III), Technical File (Annex IV), Article 25 Route](/artifacts/eu/machinery-regulation/requirements.md): An implementation-grade breakdown of Regulation (EU) 2023/1230 covering scope and definitions, Annex I routing, Annex III risk assessment, Annex IV evidence. - [Risk Assessment Method | EU Machinery Regulation (EU) 2023/1230 | Annex III General Principles Workflow](/artifacts/eu/machinery-regulation/risk-assessment-method.md): A practical risk assessment method aligned to EU Machinery Regulation (EU) 2023/1230 Annex III general principles. - [Scope and Machine Categories | EU Machinery Regulation (EU) 2023/1230 | Machinery, Related Products, Partly Completed Machinery, Annex I](/artifacts/eu/machinery-regulation/scope-and-machine-categories.md): A practical scope guide for EU Machinery Regulation (EU) 2023/1230: what counts as machinery, related products (interchangeable equipment. - [Software and Cybersecurity Considerations | EU Machinery Regulation (EU) 2023/1230 | Control Systems, Protection Against Corruption, Logs](/artifacts/eu/machinery-regulation/software-and-cybersecurity-considerations.md): A practical guide to software and cybersecurity-related safety duties under Regulation (EU) 2023/1230: Annex III protection against corruption. - [Technical Documentation and Technical File | EU Machinery Regulation (EU) 2023/1230 | Annex IV Part A/B Checklist + Structure](/artifacts/eu/machinery-regulation/technical-documentation-and-technical-file.md): A practical Annex IV guide for Regulation (EU) 2023/1230: Part A vs Part B file structure, risk-assessment content, standards mapping. - [Templates | EU Machinery Regulation (EU) 2023/1230 | Route Memo, Annex IV Technical File Index, DoC/DoI, Risk Assessment Mapping](/artifacts/eu/machinery-regulation/machinery-ce-documentation-template.md): Copy/paste templates for EU Machinery Regulation (EU) 2023/1230 compliance: scope memo (Article 2 exclusions), Annex I classification note. - [Timeline and Transition | EU Machinery Regulation (EU) 2023/1230 | From Machinery Directive 2006/42/EC to 14 Jan 2027](/artifacts/eu/machinery-regulation/timeline-and-transition.md): A grounded migration guide for Regulation (EU) 2023/1230 covering adoption on 14 June 2023, publication on 29 June 2023, entry into force on 19 July 2023. ## Key dates from adoption to mandatory application *Machinery Timeline* Track key milestones that affect planning, standards strategy, and transition from the Machinery Directive to the Machinery Regulation. ## Which compliance path applies to your machinery *Machinery Decision Flow* Use the decision flow to confirm scope, check Annex I, and map the Article 25 conformity assessment route, then translate outcomes into evidence and documentation tasks. *Next step* ## Turn EU Machinery Regulation Timeline and Decision Flow into an operational assessment workflow EU Machinery Regulation Timeline and Decision Flow should be the shared entry point for your team. Route execution into Assessment Autopilot for live work and into SSOT when the artifact needs deeper research, evidence governance, or supporting analysis. - Start from EU Machinery Regulation Timeline and Decision Flow and route the work by entity, product, team, or control owner. - Use Assessment Autopilot to turn the guidance into owned tasks, evidence requests, and review checkpoints. - Use SSOT to keep documents, evidence, and control records in one governed system. - Move from artifact reading to accountable execution without rebuilding the guidance in separate files. - [Open Assessment Autopilot](/solutions/assessment.md): Turn the guidance into owned tasks, evidence requests, and review checkpoints for EU Machinery Regulation Timeline and Decision Flow. - [Open SSOT](/solutions/ssot.md): Keep documents, evidence, and control records in one governed system from the same artifact. - **Download decision flow**: Share compliance logic with your team. - **Download timeline**: Coordinate milestones across teams. - [Talk through EU Machinery Regulation Timeline and Decision Flow](/contact.md): Review your current process, evidence model, and next steps for EU Machinery Regulation Timeline and Decision Flow. ## Decision Steps ### STEP 1: Is your product within the scope of the Machinery Regulation? *Reference: Art. 2(1)* - Regulation (EU) 2023/1230 applies to machinery, related products (interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, removable mechanical transmission devices) and partly completed machinery. - Check Article 2(2) exclusions before proceeding. - **NO** Out of Scope - **YES** Does an Article 2(2) exclusion apply to your product? ### STEP 2: Does an Article 2(2) exclusion apply to your product? *Reference: Art. 2(2)* - Review the full list of exclusions in Article 2(2). - If yes, the Machinery Regulation does not apply. - If no, continue to determine the product category and applicable requirements. - **YES** Out of Scope - **NO** Which product category applies? ### STEP 3: Which product category applies? - Machinery or related product: follow the full compliance track (Annex III requirements, technical documentation, conformity assessment, EU declaration of conformity, CE marking). - Partly completed machinery: follow the incorporation track (relevant Annex III requirements, technical documentation, EU declaration of incorporation, assembly instructions). - The category determines the applicable obligations and documentation. - -> Is your product machinery or a related product (not partly completed)? ### MACHINERY TRACK: Is your product machinery or a related product (not partly completed)? *Reference: Art. 2(1) and Art. 3* - Machinery is defined in Art. 3(1). - Related products are listed in Art. 2(1) and defined in Art. 3 (interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, removable mechanical transmission devices). - If yes: follow the machinery/related product compliance track. - If no: check if it is partly completed machinery. - **YES** Is your machinery/related product listed in Annex I? - **NO** Is your product partly completed machinery? ### PCM TRACK: Is your product partly completed machinery? *Reference: Art. 3(10)* - Partly completed machinery (PCM) is an assembly that is not yet machinery because it cannot in itself perform a specific application and is only intended to be incorporated into or assembled with other machinery/partly completed machinery or equipment. - If yes: follow the partly completed machinery track (notably Art. 11, Art. 22, Annex IV Part B, Annex V Part B, and Annex XI). - If no and not excluded: verify scope again or product may be a component not regulated by Machinery Regulation. - **YES** Partly Completed Machinery Track - **NO** Out of Scope ### STEP 4: Is your machinery/related product listed in Annex I? *Reference: Art. 25 & Annex I* - Annex I lists categories of machinery/related products requiring specific conformity assessment procedures. - Annex I Part A: 6 categories with mandatory notified body involvement (including AI/machine learning safety components/systems). - Annex I Part B: 19 categories where notified body involvement may be optional if harmonised standards or common specifications covering all relevant requirements are applied. - If not in Annex I: internal production control (Module A) applies (self-assessment). - If in Annex I: check which Part. - **NO** Module A - Internal Production Control - **YES** Is your product in Annex I Part A (mandatory notified body)? ### STEP 5: Is your product in Annex I Part A (mandatory notified body)? *Reference: Art. 25(2) & Annex I Part A* - Annex I Part A categories (6 total): (1) Removable mechanical transmission devices including guards; (2) Guards for removable mechanical transmission devices; (3) Vehicle servicing lifts; (4) Portable cartridge-operated fixing and other impact machinery; (5) Safety components with fully/partially self-evolving behaviour using machine learning ensuring safety functions; (6) Machinery with embedded systems using machine learning ensuring safety functions (for those systems only). - If yes: apply one of the Art. 25(2) procedures involving a notified body (Module B+C, Module H, or Module G). - If no: check if product is in Annex I Part B. - **YES** Notified Body Involvement Required - **NO** Is your product in Annex I Part B (optional notified body)? ### STEP 6: Is your product in Annex I Part B (optional notified body)? *Reference: Art. 25(3) & Annex I Part B* - Annex I Part B categories (19 total): (1) Circular saws for wood/meat; (2) Hand-fed surface planing machinery for woodworking; (3) Thicknessers; (4) Band-saws; (5) Combined machinery; (6) Hand-fed tenoning machinery; (7) Vertical spindle moulding machinery; (8) Portable chainsaws; (9) Presses for cold working metals; (10) Injection/compression plastics-moulding machinery; (11) Injection/compression rubber-moulding machinery; (12) Underground machinery; (13) Refuse collection trucks; (14) Devices for lifting persons (>3m); (15) Protective devices detecting presence of persons; (16) Power-operated interlocking movable guards; (17) Logic units ensuring safety functions; (18) ROPS; (19) FOPS. - If yes: you may apply Module A only when the product is designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements; otherwise apply one of the Art. 25(3)(b)-(d) procedures involving a notified body. - If no: Module A (internal production control) applies. - **YES** For Annex I Part B: Are harmonised standards or common specifications applied? - **NO** Module A - Internal Production Control ### STEP 7: For Annex I Part B: Are harmonised standards or common specifications applied? *Reference: Art. 20 & Art. 25(3)* - Harmonised standards are European standards cited in the Official Journal providing presumption of conformity with corresponding essential requirements (Art. 20(1)). - Common specifications may be established by Commission implementing acts where harmonised standards do not exist or are insufficient and for specific reasons (Art. 20(3)). - If harmonised standards or common specifications are applied and are specific to that category and cover all relevant essential health and safety requirements: Module A (self-assessment) may be used. - If not applied or do not cover all relevant requirements for that category: apply one of the Art. 25(3)(b)-(d) procedures involving a notified body. - **YES** Module A - Internal Production Control - **NO** Notified Body Involvement Required ## Reference Information ### Products Within Scope (Overview) - Machinery: defined in Art. 3(1) and includes assemblies with a drive system, assemblies missing only site-connection or energy sources, certain human-powered lifting assemblies, and assemblies missing only the software intended for the specific application. - Related products: interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, and removable mechanical transmission devices (Art. 2(1), with definitions in Art. 3). - Partly completed machinery: an assembly not yet machinery because it cannot in itself perform a specific application and is intended to be incorporated into or assembled with other machinery/partly completed machinery or equipment (Art. 3(10)). ### Key Exclusions - Art. 2(2) excludes certain products from the Regulation (for example: certain spare safety components, certain transport products, and certain electrical and electronic products covered by the LVD or RED). Review the full list in Art. 2(2). - Where risks covered by more specific Union harmonisation legislation apply, Machinery Regulation does not apply to that product for those risks (Art. 9). ### Manufacturer Obligations (Machinery & Related Products) - Ensure machinery/related product is designed and constructed in accordance with the essential health and safety requirements in Annex III (Art. 10(1)). - Before placing on the market or putting into service: draw up technical documentation (Annex IV Part A) and apply the relevant conformity assessment procedure (Art. 10(2) and Art. 25). - After conformity is demonstrated: draw up the EU declaration of conformity (Art. 21 and Annex V Part A) and affix the CE marking (Art. 24) (Art. 10(2)). - Keep technical documentation and the EU declaration of conformity available to market surveillance authorities for at least 10 years; provide source code or programming logic on reasoned request where necessary for checking compliance (Art. 10(3)). - Maintain procedures so series production remains in conformity; take account of changes in production/design and changes in harmonised standards/technical specifications/common specifications (Art. 10(4)). - Mark the machinery/related product with the required identification information, including year of construction (year the manufacturing process was completed) (Art. 10(5)). - Indicate manufacturer name/trade name or trademark and contact details (postal address plus website/email/other digital contact) (Art. 10(6)). - Provide instructions for use and the information set out in Annex III; digital instructions are permitted with conditions, and certain safety information must be provided in paper for non-professional users (Art. 10(7)). - Provide the EU declaration of conformity with the product or provide an internet address or machine-readable code where it can be accessed; digital EU declarations of conformity must remain accessible online for the expected lifetime and at least 10 years (Art. 10(8)). - Take corrective action for non-conformity or risk and inform authorities where required (Art. 10(9)). ### Manufacturer Obligations (Partly Completed Machinery) - Ensure PCM is designed and constructed in accordance with the relevant essential health and safety requirements in Annex III (Art. 11(1)). - Before placing on the market: draw up technical documentation (Annex IV Part B) and, where compliance is demonstrated in that documentation, draw up the EU declaration of incorporation (Art. 11(2) and Art. 22). - Keep technical documentation and the EU declaration of incorporation available to market surveillance authorities for at least 10 years; provide source code or programming logic on reasoned request where necessary for checking compliance (Art. 11(3)). - Maintain procedures so series production remains in conformity, taking account of changes in production/design and changes in harmonised standards/technical specifications/common specifications (Art. 11(4)). - Mark the PCM with the required identification information, including year of construction (year the manufacturing process was completed) (Art. 11(5)). - Indicate manufacturer name/trade name or trademark and contact details (postal address plus website/email/other digital contact) (Art. 11(6)). - Provide assembly instructions (Annex XI); digital assembly instructions are permitted with conditions (Art. 11(7)). - Provide the EU declaration of incorporation with the PCM or provide an internet address or machine-readable code where it can be accessed in the assembly instructions; digital EU declarations of incorporation must remain accessible online for at least 10 years (Art. 11(8)). ### Economic Operators Obligations - Authorised representative (Art. 12): manufacturer may appoint written authorised representative to act on behalf in EU; representative carries out tasks specified in mandate (min. keep EU declaration of conformity and technical documentation at disposal of market surveillance authorities; provide authorities with information/documentation; cooperate on action to eliminate risks). - Importers (Art. 13): place only conforming products on market; verify manufacturer compliance (CE marking, documentation, markings); add own name/address; ensure transport/storage does not jeopardise conformity; keep copy of EU declaration of conformity for 10 years; take corrective action for non-conforming/risky products. - Distributors (Art. 14): verify product bears CE marking, is accompanied by documentation, and bears required markings; ensure transport/storage does not jeopardise conformity; take corrective action if become aware of non-conformity/risk; cooperate with authorities. - Cases where obligations of manufacturers apply (Art. 17): importer/distributor/authorised representative who places product on market under own name/trademark or modifies product such that conformity may be affected becomes manufacturer. ### CE Marking and EU Declaration of Conformity - The CE marking must be affixed visibly, legibly and indelibly; it must be affixed before the machinery/related product is placed on the market or put into service (Art. 24(1)-(2)). - Where conformity is assessed under Art. 25(2)(a)-(c) or Art. 25(3)(b)-(d), the CE marking must be followed by the identification number of the notified body involved (Art. 24(3)). - General principles of the CE marking apply (Art. 23). - The EU declaration of conformity states that fulfilment of the applicable essential health and safety requirements in Annex III has been demonstrated (Art. 21(1)). - The EU declaration of conformity uses the model structure in Annex V Part A and contains elements specified in the relevant modules; it is continuously updated and translated into the language(s) required by the Member State (Art. 21(2)). - A single EU declaration of conformity may cover multiple Union legal acts if it identifies the acts concerned (Art. 21(3)). - By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for compliance with the Regulation (Art. 21(4)). - Manufacturers must ensure the EU declaration of conformity accompanies the product or provide an internet address or machine-readable code where it can be accessed; digital EU declarations must remain accessible online during the expected lifetime and at least 10 years (Art. 10(8)). ### Essential Health and Safety Requirements - Annex III sets out essential health and safety requirements for design and construction of machinery and related products. - Annex III Part A: Definitions (hazard, danger zone, exposed person, operator, risk, guard, protective device, intended use, reasonably foreseeable misuse). - Annex III Part B: General principles - manufacturer must carry out risk assessment (identify limits, hazards, estimate risks, evaluate risks, eliminate/reduce risks by inherent safe design, technical protective measures, information for use) and design/construct accordingly. - Annex III Part C: General essential health and safety requirements (controls, starting, stopping, operating modes, risks from moving parts, required characteristics of guards/protective devices, risks from other hazards, maintenance, indications/markings/warnings, etc.). - Annex III Parts D-F: Supplementary requirements for certain categories (machinery for foodstuffs/cosmetics/pharmaceuticals; portable hand-held/hand-guided machinery; machinery for lifting operations). - Annex III Part G: Requirements to deal with hazards due to mobility of machinery. - Annex III Part H: Requirements for machinery designed to lift or move persons. - Requirements apply where relevant hazard exists for the machinery/related product concerned. ### AI, Digital and Cybersecurity Requirements - Annex I Part A items 5 and 6 cover certain safety components and embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions; these categories require a conformity assessment procedure involving a notified body (Art. 25(2)). - Annex II includes software ensuring safety functions (item 18) and safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions (item 19). - Annex III section 1.1.9 (protection against corruption) requires protection of critical hardware, software, and data against accidental or intentional corruption, including when connected to other devices or remote devices. - Annex III section 1.2.1 (safety and reliability of control systems) addresses faults and logic errors, and includes requirements related to reasonably foreseeable malicious attempts from third parties and safety-function limits during learning phases where relevant. - Art. 20(9) provides a presumption of conformity for Annex III sections 1.1.9 and 1.2.1 when a product is certified under certain EU cybersecurity certification schemes (Regulation (EU) 2019/881) to the extent covered by the certificate. ### Notified Bodies (Conformity Assessment) - Notifying authorities (Art. 27): Member States designate notifying authority responsible for notification procedures and monitoring of notified bodies; must be independent and impartial. - Requirements for notified bodies (Art. 30): legal person; independent and impartial; staff with technical competence and professional integrity; covered by liability insurance or Member State assumes liability; safeguards confidentiality; documented procedures. - Presumption of conformity (Art. 31): bodies demonstrating conformity with criteria in harmonised standards or accredited per Regulation (EC) No 765/2008 presumed to comply with Art. 30 requirements. - Application for notification (Art. 33): conformity assessment body applies to notifying authority with documentation demonstrating compliance. - Notification procedure (Art. 34): if body meets requirements, notifying authority notifies Commission (using electronic notification tool NANDO) and other Member States; Commission assigns identification number and publishes list. - Operational obligations (Art. 38): carry out conformity assessments per applicable procedures; avoid unnecessary burden; respect confidentiality; proportionate assessment; inform authorities of refusals/restrictions/suspensions/withdrawals; respond to requests; participate in coordination activities. - Changes to notifications (Art. 36): notified body informs notifying authority of changes affecting notification; authority assesses and may restrict/suspend/withdraw. ### Market Surveillance and Safeguards - Art. 43 sets out the national procedure for products presenting a risk and refers to corrective action as provided for in Art. 16(3) of Regulation (EU) 2019/1020. - Procedure at national level (Art. 43): if Member State finds non-complying product or product presenting risk, market surveillance authority requires economic operator to take corrective action; if risk persists, authority ensures product withdrawn/recalled or availability restricted/prohibited. - Union safeguard procedure (Art. 44): if Member State takes measures and considers action necessary EU-wide, informs Commission and other Member States; Commission assesses whether measure justified; if not justified, Member State must withdraw; if justified, all Member States take necessary measures. - Compliant products presenting risk (Art. 45): if compliant product still presents risk to health/safety, Member State may take provisional measures; inform Commission with justification; Commission evaluates and may adopt implementing acts. - Formal non-compliance (Art. 46): for non-compliance with formal obligations (CE marking, EU declaration of conformity, technical documentation, markings), Member State requires economic operator to end non-compliance; if persists, restrict/prohibit or ensure withdrawal/recall. ### Transition from Directive 2006/42/EC - Directive 2006/42/EC repealed with effect from 20 January 2027 (Art. 51(2)). - Member States must not impede making available on market of products placed on market in conformity with Directive 2006/42/EC before 20 January 2027 (Art. 52(1)). - However, Chapter VI (safeguard procedures) of Regulation (EU) 2023/1230 applies from 19 July 2023 onwards to products under Directive 2006/42/EC (Art. 52(1)). - EC type-examination certificates and approval decisions issued per Directive 2006/42/EC remain valid until they expire (Art. 52(2)). - From 20 January 2027, Regulation (EU) 2023/1230 applies (Art. 54) and replaces Directive 2006/42/EC (Art. 51(2)). ### Penalties and Enforcement - Member States must lay down rules on penalties for infringements by economic operators; penalties must be effective, proportionate and dissuasive; may include criminal penalties for serious infringements (Art. 50(1)). - Member States must notify the Commission of penalty rules and measures by 20 October 2026 and notify amendments without delay (Art. 50(2)). - Art. 54 specifies that Art. 50(1) applies from 20 October 2026. ### Evaluation and Review - Commission must submit report on evaluation and review by 20 July 2028 and every four years thereafter (Art. 53(1)). - Report must include evaluation of essential health and safety requirements (Annex III) and conformity assessment procedure applicable to machinery/related products in Annex I, taking account of technical progress and practical experience (Art. 53(2)). - Commission must submit specific report on assessment of Article 6(4) and (5) (categories of machinery/related products in Annex I and Member State data collection) by 20 July 2026 and every five years thereafter (Art. 53(3)). - The Commission is empowered to adopt delegated acts referred to in Articles 6(2), 6(11) and 7(2); the delegation is conferred for five years from 19 July 2023 and is tacitly extended unless the European Parliament or the Council opposes (Art. 47(2)). - Annex I can be amended by delegated acts in accordance with the criteria and procedure in Article 6 (e.g., adding, withdrawing, or moving categories between Part A and Part B). ### Internal Market Emergency Mode - Amending Regulation (EU) 2024/2748 (Internal Market Emergency and Resilience Act amendments) applies from 29 May 2026. - Once internal market emergency mode activated per Regulation (EU) 2024/2747, special procedures apply to crisis-relevant goods/services. - Conformity-assessment bodies must prioritise applications for conformity of crisis-relevant products over non-crisis products. - Member States may, on exceptional basis with duly justified request, temporarily authorise placing on market of machinery/related products/PCM without normal conformity assessment where notified body involvement mandatory, provided all essential requirements can be ensured. - Member States' authorities may presume conformity where products manufactured per EU standards, relevant national standards, or international standards identified by Commission as suitable. - Commission may adopt common specifications by implementing acts on which manufacturers can rely for presumption of conformity (remain applicable for duration of emergency mode). - These provisions aim to avoid disruptions to internal market in event of emergency (pandemic, natural disaster, etc.). ### Technical Documentation Requirements - Annex IV Part A (machinery/related products): technical documentation specifies the means used to ensure conformity with the applicable essential health and safety requirements in Annex III. - Annex IV Part A includes at least: product description and intended use; risk assessment documentation (including applicable EHSRs, protective measures and residual risks); drawings/schemes and explanations; standards/common specifications or other technical specifications applied; reports/results of calculations, tests and examinations; and production measures to ensure ongoing conformity. - Annex IV Part A also includes: copy of instructions for use and information set out in Annex III section 1.7.4; and, where appropriate, declarations/instructions for incorporated partly completed machinery and declarations for incorporated products subject to other Union harmonisation legislation. - Annex IV Part A may include source code or programming logic on reasoned request where necessary for authorities to check compliance; and includes additional descriptions for certain sensor-fed, remotely-driven, or autonomous machinery where relevant. - Annex IV Part B (partly completed machinery): similar structure tailored to PCM, including intended function when incorporated, risk assessment, drawings/explanations, applied standards/specifications, test results, production measures, and a copy of the assembly instructions set out in Annex XI. ### Instructions for Use and Safety Information - Manufacturers must ensure machinery/related products are accompanied by instructions for use and the information set out in Annex III; instructions may be provided in digital format subject to conditions, and certain safety information must be provided in paper for non-professional users (Art. 10(7)). - Annex III section 1.7.4 sets additional rules for drafting instructions for use and lists required contents (including, where applicable, the EU declaration of conformity or a link/code to access it in accordance with Art. 10(8)). - When instructions are provided digitally, Art. 10(7) sets conditions (including how users access them, ability to print/download, online accessibility during expected lifetime and at least 10 years after placing on the market, and provision of paper instructions on request within one month). - For partly completed machinery, manufacturers must provide assembly instructions set out in Annex XI; assembly instructions may be provided digitally subject to conditions and a paper copy must be provided on request within one month (Art. 11(7)). - For partly completed machinery, the EU declaration of incorporation must accompany the product or be accessible via an internet address or machine-readable code included in the assembly instructions (Art. 11(8) and Annex V Part B). ## Possible Outcomes ### [RESULT] Module A - Internal Production Control Self-assessment procedure - Apply internal production control (Module A) as set out in Annex VI. - Ensure the machinery/related product meets the applicable essential health and safety requirements in Annex III and compile the required technical documentation (Annex IV Part A). - Draw up the EU declaration of conformity (Annex V Part A) and affix the CE marking after conformity is demonstrated. - No notified body involvement is required. ### [RESULT] Notified Body Involvement Required Module B+C, Module H, or Module G - Annex I Part A categories: apply one of the Art. 25(2) procedures (Module B+C, Module H, or Module G). - Annex I Part B categories: if Module A cannot be used, apply one of the Art. 25(3)(b)-(d) procedures (Module B+C, Module H, or Module G). - Module B (EU type-examination) is set out in Annex VII; Module C (conformity to type based on internal production control) is set out in Annex VIII. - Module H (full quality assurance) is set out in Annex IX; Module G (unit verification) is set out in Annex X. - Affix the CE marking and draw up the EU declaration of conformity after conformity assessment is completed. ### [RESULT] Partly Completed Machinery Track EU declaration of incorporation + assembly instructions - Design and document the PCM against the relevant essential health and safety requirements in Annex III (Art. 11(1)). - Draw up technical documentation (Annex IV Part B) and the EU declaration of incorporation (Annex V Part B) (Art. 11(2) and Art. 22). - Provide assembly instructions (Annex XI) and include the EU declaration of incorporation or an internet address or machine-readable code where it can be accessed (Art. 11(7)-(8)). - The EU declaration of incorporation includes a statement that the PCM shall not be put into service until the final machinery has been declared in conformity with the Regulation (Annex V Part B). ### [RESULT] Out of Scope Machinery Regulation does not directly apply - Your product is not within the scope of Regulation (EU) 2023/1230, or an Article 2(2) exclusion applies. - Other Union harmonisation legislation or national requirements may still apply depending on the product. ## Machinery Regulation Timeline | Date | Event | Reference | | --- | --- | --- | | 2023-06-14 | Regulation (EU) 2023/1230 adopted | Reg. (EU) 2023/1230 | | 2023-06-29 | Published in Official Journal (OJ L 165) | Reg. (EU) 2023/1230 | | 2023-07-19 | Entry into force (20 days after publication) | Art. 54 | | 2023-07-19 | Article 6(7), Articles 48 and 52 apply | Art. 54 | | 2024-01-20 | Articles 26 to 42 (notified bodies) apply | Art. 54 | | 2024-07-20 | Article 6(2)-(6), (8), (11), Articles 47, 53(3) apply | Art. 54 | | 2026-10-20 | Member States notify penalties rules; Article 50(1) applies | Art. 50(2) & Art. 54 | | 2027-01-20 | Regulation fully applies; Directive 2006/42/EC repealed | Art. 51(2) & Art. 54 | ## Compliance Timeline | Date | Event | Category | Reference | | --- | --- | --- | --- | | 2006-05-17 | Machinery Directive 2006/42/EC Adopted | Legacy Directive | | | 2006-12-19 | Standardization Mandate M/396 Issued | Standards & Guidance | | | 2009-10-21 | Directive 2009/127/EC on Pesticide Machinery | Legacy Directive | | | 2010-06-29 | Standardization Mandate M/471 Issued | Standards & Guidance | | | 2019-07-26 | Latest Consolidated Machinery Directive | Legacy Directive | | | 2023-04-18 | European Parliament Position (First Reading) | Legislative Process | | | 2023-05-22 | Council Decision (Legislative Process) | Legislative Process | | | 2023-05-26 | CEN-CENELEC Machinery Webinar (Standardisation Q&A) | Standards & Guidance | | | 2023-06-14 | Machinery Regulation (EU) 2023/1230 Adopted | Legislative Process | | | 2023-06-29 | Regulation Published in Official Journal | Legislative Process | | | 2023-07-04 | Corrigendum Published | Legislative Process | | | 2023-07-19 | Regulation Enters into Force | Application Dates | | | 2024-01-20 | Notified Bodies Provisions Apply | Application Dates | | | 2024-02-23 | CEN-CENELEC Gap Analysis Webinar | Standards & Guidance | | | 2024-06-13 | Machinery Directive Guide Edition 2.3 Published | Standards & Guidance | | | 2024-07-20 | Category Review and Data Collection Provisions Apply | Application Dates | | | 2025-01-20 | Standardization Request C(2025) 129 Adopted | Standards & Guidance | | | 2025-07-20 | First Member State data submission deadline | Implementation | | | 2025-07-20 | Draft Joint Work Programme Due | Standards & Guidance | | | 2026-01-20 | Standards Amendment Status Report Due | Standards & Guidance | | | 2026-01-20 | Standardisation Request Priority Deliverables Target | Standards & Guidance | | | 2026-03-31 | Draft Standards (DAV) Window Ends | Standards & Guidance | | | 2026-05-29 | Emergency Procedures Regulation Applies | Legislative Process | | | 2026-07-20 | First Joint Annual Report Due | Standards & Guidance | | | 2026-10-20 | Penalties Provisions Apply; Member State Notification Due | Application Dates | | | 2027-01-20 | Machinery Regulation Mandatory Application Begins | Application Dates | | | 2027-01-20 | Machinery Directive 2006/42/EC Repealed | Transition Period | | | 2028-07-20 | First Evaluation Report Due | Implementation | | | 2034-01-20 | Standardisation Request Follow Up Deliverables Target | Standards & Guidance | | | 2035-01-20 | Standardization Request Final Report and Expiry | Standards & Guidance | | **Event details:** - **2006-05-17 - Machinery Directive 2006/42/EC Adopted**: Directive 2006/42/EC on machinery adopted, establishing harmonized rules for machinery safety requirements across the EU. This directive served as the foundation for machinery regulation for over 20 years. - **2006-12-19 - Standardization Mandate M/396 Issued**: Commission issued Mandate M/396 to CEN and CENELEC to check and adjust harmonized standards to ensure full compliance with Directive 2006/42/EC and provide specifications for manufacturers. - **2009-10-21 - Directive 2009/127/EC on Pesticide Machinery**: Directive 2009/127/EC adopted, amending Directive 2006/42/EC with regard to machinery for pesticide application, introducing new essential health and safety requirements. - **2010-06-29 - Standardization Mandate M/471 Issued**: Commission issued Mandate M/471 to CEN to develop harmonized standards supporting new essential health and safety requirements for environmental protection in Directive 2006/42/EC. - **2019-07-26 - Latest Consolidated Machinery Directive**: Final consolidated version of Machinery Directive 2006/42/EC published, incorporating all amendments and corrections before the transition to the new Regulation. - **2023-04-18 - European Parliament Position (First Reading)**: European Parliament position adopted on 18 April 2023 during the legislative process for Regulation (EU) 2023/1230 (as referenced in the Regulation text timeline metadata). - **2023-05-22 - Council Decision (Legislative Process)**: Council decision dated 22 May 2023 referenced in the Regulation text timeline metadata as part of the legislative process leading to Regulation (EU) 2023/1230. - **2023-05-26 - CEN-CENELEC Machinery Webinar (Standardisation Q&A)**: CEN-CENELEC webinar held on 26 May 2023 on the transition to the Machinery Regulation and related standardisation topics (per Q&A report timeline metadata). - **2023-06-14 - Machinery Regulation (EU) 2023/1230 Adopted**: European Parliament and Council adopted Regulation (EU) 2023/1230 on machinery, repealing Directive 2006/42/EC and Council Directive 73/361/EEC. - **2023-06-29 - Regulation Published in Official Journal**: Regulation (EU) 2023/1230 published in the Official Journal of the European Union (OJ L 165, 29.6.2023, pp. 1-102), making it the authentic legal text. - **2023-07-04 - Corrigendum Published**: Corrigendum issued to address a clerical error regarding application dates in the original version of the Regulation (OJ L 169, 4.7.2023, p. 35). - **2023-07-19 - Regulation Enters into Force**: Regulation (EU) 2023/1230 entered into force. Article 6(7), Article 48 (committee procedure), and Article 52 (transitional provisions) apply from this date. Delegated powers conferred for 5 years. - **2024-01-20 - Notified Bodies Provisions Apply**: Articles 26 to 42 apply from this date, establishing the framework for notification, requirements, and operational obligations of conformity assessment bodies. - **2024-02-23 - CEN-CENELEC Gap Analysis Webinar**: CEN-CENELEC hosted webinar on gap-analysis of harmonized standards for Machinery against the new Regulation, explaining alignment process and tools for standards bodies. - **2024-06-13 - Machinery Directive Guide Edition 2.3 Published**: European Commission externalized/published the Guide to the application of the Machinery Directive 2006/42/EC, Edition 2.3 (per docsroom metadata). - **2024-07-20 - Category Review and Data Collection Provisions Apply**: Article 6(2)-(6), (8), and (11) apply, enabling Commission category review and Member State data collection. Articles 47 and 53(3) also apply, and the first implementing act for the Article 6 data collection template must be adopted not later than 20 July 2024. - **2025-01-20 - Standardization Request C(2025) 129 Adopted**: Commission Implementing Decision C(2025) 129 final adopted, issuing standardization request to CEN and CENELEC for machinery and related products in support of Regulation (EU) 2023/1230. - **2025-07-20 - First Member State data submission deadline**: By 20 July 2025 (and every five years thereafter), Member States must provide the Article 6(5) data and information for categories of machinery or related products (including when no relevant events occurred). - **2025-07-20 - Draft Joint Work Programme Due**: CEN and CENELEC must submit draft joint work programme to the Commission for developing harmonized standards under the new Regulation. - **2026-01-20 - Standards Amendment Status Report Due**: CEN and CENELEC must inform the Commission of references of harmonized standards from Decision (EU) 2023/1586 that will not be amended or revised, and reasons why. - **2026-01-20 - Standardisation Request Priority Deliverables Target**: Standardisation request annexes include a priority deadline of 20 January 2026 for deliverables aligning existing or potential harmonised standards identified through gap analysis. - **2026-03-31 - Draft Standards (DAV) Window Ends**: CEN webinar Q&A report references draft standards to be published (DAV) between mid-2024 and 31 March 2026 to support both the Machinery Directive and Machinery Regulation transition (with dual Annex ZA references). - **2026-05-29 - Emergency Procedures Regulation Applies**: Amending Regulation (EU) 2024/2748 applies, adding internal market emergency mode provisions to enable rapid market placement of crisis-relevant machinery during emergencies. - **2026-07-20 - First Joint Annual Report Due**: CEN and CENELEC must submit the first joint annual report to the Commission on progress in developing harmonized standards under the standardization request. - **2026-10-20 - Penalties Provisions Apply; Member State Notification Due**: Article 50(1) (penalties) applies from this date, and Member States must notify the Commission of their penalties rules and measures by this date (Article 50(2)). - **2027-01-20 - Machinery Regulation Mandatory Application Begins**: Regulation (EU) 2023/1230 applies on a mandatory basis. All machinery placed on the EU market from this date must comply with the new Regulation. Directive 2006/42/EC is repealed. Mandates M/396 and M/471 expire. - **2027-01-20 - Machinery Directive 2006/42/EC Repealed**: Directive 2006/42/EC formally repealed. Products placed on the market before this date in conformity with the Directive may continue to be made available. Safeguard procedures under Chapter VI apply to such products. - **2028-07-20 - First Evaluation Report Due**: Commission must submit the first report on evaluation and review of Regulation (EU) 2023/1230 to the European Parliament and Council. Reports required every 4 years thereafter. - **2034-01-20 - Standardisation Request Follow Up Deliverables Target**: Standardisation request annexes include a follow up deadline of 20 January 2034 for standards and other deliverables aligning existing or potential harmonised standards identified through gap analysis. - **2035-01-20 - Standardization Request Final Report and Expiry**: CEN and CENELEC must provide final report to the Commission. Commission Implementing Decision C(2025) 129 final on standardization request expires on this date. --- [Privacy Policy](https://www.sorena.io/privacy) | [Terms of Use](https://www.sorena.io/terms-of-use) | [DMCA](https://www.sorena.io/dmca) | [About Us](https://www.sorena.io/about-us) (c) 2026 Sorena AB (559573-7338). All rights reserved. Source: https://www.sorena.io/artifacts/eu/machinery-regulation