--- title: "Templates" canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/machinery-ce-documentation-template" source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/machinery-ce-documentation-template" author: "Sorena AI" description: "Copy/paste templates for EU Machinery Regulation (EU) 2023/1230 compliance: scope memo (Article 2 exclusions), Annex I classification note." published_at: "2026-02-21" updated_at: "2026-02-21" keywords: - "EU Machinery Regulation template" - "machinery regulation technical file template" - "Annex IV index template" - "Article 25 route memo template" - "EU declaration of conformity machinery template" - "declaration of incorporation template" - "EHSR mapping template" - "templates" - "Annex IV" - "DoC" - "DoI" - "Article 25" --- **[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) --- # Templates Copy/paste templates for EU Machinery Regulation (EU) 2023/1230 compliance: scope memo (Article 2 exclusions), Annex I classification note. *Templates* *EU* ## EU Machinery Regulation (EU) 2023/1230 Templates Reusable artifacts for route decisions and CE evidence packs. Copy/paste these into your technical file system and keep them versioned. These templates reflect what reviewers actually look for: a defensible route decision, a risk assessment-to-EHSR map, and an exportable Annex IV technical file index. Use them per product family and link every field to evidence locations and versions. ## 1) Scope memo template (Article 2 + product type) Purpose: a one-page, defensible scope decision per product family. - Product ID: model(s), variants, intended use, environment, operators/exposed persons. - Product type: machinery / related product (which one) / partly completed machinery / safety component (incl. software). - Exclusions checklist (Article 2(2)): list each relevant exclusion and mark 'not applicable' with rationale. - Electrical products exclusion check: confirm whether the product is excluded insofar as it falls under LVD/RED categories. - Applicable legislation list: include other EU acts if incorporated products require them (for DoC/DoI statements). *Recommended next step* *Placement: after the template, evidence, or documentation block* ## Keep EU Machinery Regulation (EU) 2023/1230 Templates in one governed evidence system SSOT can take EU Machinery Regulation (EU) 2023/1230 Templates from reusing this material inside a governed evidence system to a reusable workflow inside Sorena. Teams working on EU Machinery Regulation (EU) 2023/1230 can keep owners, evidence, and next steps aligned without copying this guide into separate documents. - [Open SSOT for EU Machinery Regulation (EU) 2023/1230 Templates](/solutions/ssot.md): Start from EU Machinery Regulation (EU) 2023/1230 Templates and keep documents, evidence, and control records in one governed system. - [Talk through EU Machinery Regulation (EU) 2023/1230](/contact.md): Review your current process, evidence gaps, and next steps for EU Machinery Regulation (EU) 2023/1230 Templates. ## 2) Annex I classification note (Part A / Part B / not listed) Purpose: a precise category match that drives the Article 25 route. - Annex I match: exact item number and sub-item where applicable. - Rationale: product facts that match the category definition. - Boundary: which parts/systems are covered by the category match (especially for embedded systems). - Decision: Part A / Part B / not listed; link to route memo. ## 3) Article 25 route decision memo template Purpose: a route decision that is stable and reviewable (and defines change triggers). - Selected procedure: Article 25(2) (B+C / H / G) or Article 25(3) or 25(4) (Module A). - If Part B + Module A: evidence that harmonised standards/common specs for that category cover all relevant EHSR and are applied. - Notified body involvement plan (if applicable): scope, schedule, evidence readiness date, change control triggers. - CE marking implications: include notified body identification number when required. - Outputs: technical file index + declarations + release gate checklist. ## 4) Annex III risk assessment and EHSR mapping table (EHSR -> measures -> evidence) Purpose: a single mapping table that connects the safety case to evidence artifacts. - EHSR (Annex III) | Hazard/hazardous situation | Protective measure | Verification method | Evidence ID | Residual risk + instruction reference - Include lifecycle phases and foreseeable misuse assumptions in the header. - Include autonomy/self-evolving behavior and system interaction hazards where relevant. ## 5) Annex IV technical file index template (Part A/B) Purpose: an exportable index that makes the file reviewable in minutes. - 00-Index/: scope memo, Annex I note, route memo, index.pdf/json - 01-Risk/: hazard log, EHSR mapping table, residual risks register - 02-Design/: drawings, schematics, safety functions description - 03-Standards/: standards/common specs register, clause mapping, update log - 04-Verification/: test plan, test reports, inspections, calculations - 05-Production/: series conformity controls - 06-Instructions/: instructions for use, translations; assembly instructions if partly completed - 07-Declarations/: DoC/DoI, history, signatory evidence - 08-Software-Control/: software inventory, intervention logs, validation summaries (as applicable) ## 6) EU Declaration of Conformity (DoC) skeleton Purpose: a DoC that matches the route, evidence pack, and any incorporated-product obligations. - Product identification; manufacturer details; authorised representative (if any). - Statement of sole responsibility. - Applicable Union harmonisation legislation: include Regulation (EU) 2023/1230 and any other applicable acts for incorporated products (where relevant). - Standards/common specifications references (with versions). - If notified body involved: include certificate references and ensure CE marking number handling is consistent. - Signatory details (name, function, place/date, signature). ## 7) Partly completed machinery pack: Declaration of Incorporation + assembly instructions checklist Purpose: a coherent pack for incorporation customers and for authority requests. - Declaration of Incorporation (DoI) issued and kept updated; translated as required. - Assembly instructions provided and aligned to residual risks and incorporation conditions. - Digital provision policy defined where used: users must be able to print/download and access during breakdowns; online accessibility period tracked where applicable. - Annex IV Part B technical documentation index complete. ## 8) Notified body assessment pack outline (for Annex I routes) Purpose: reduce notified body cycle time with a clean evidence narrative. - Route memo + Annex I classification + system boundaries. - EHSR mapping summary and key protective measures narrative. - Key verification evidence set (representative tests, inspections, calculations). - Change history and configuration control (software versions, safety functions versions). ## Primary sources - [Regulation (EU) 2023/1230 - Annex I (categories), Article 25 (procedures), Annex III (EHSR), Annex IV (technical documentation) (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2023/1230/oj?ref=sorena.io) - Primary structure for route decisions, risk assessment mapping, and technical file content. - [European Commission - Machinery (Single Market) page](https://single-market-economy.ec.europa.eu/sectors/mechanical-engineering/machinery_en?ref=sorena.io) - Commission overview and entry point for notified bodies and sector resources. ## Related 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. - [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. --- [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). 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