--- title: "Conformity Assessment and CE Marking" canonical_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/conformity-assessment-and-ce" source_url: "https://www.sorena.io/artifacts/eu/machinery-regulation/conformity-assessment-and-ce" author: "Sorena AI" description: "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." published_at: "2026-02-21" updated_at: "2026-02-21" keywords: - "EU Machinery Regulation conformity assessment" - "Article 25 modules" - "Annex I Part A Part B route" - "Module A machinery regulation" - "EU type examination module B" - "full quality assurance module H" - "unit verification module G" - "CE marking notified body number" - "Article 25" - "Annex I" - "CE marking" - "notified body" - "technical documentation" --- **[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) --- # Conformity Assessment and CE Marking 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. *CE Marking* *EU* ## EU Machinery Regulation (EU) 2023/1230 Conformity Assessment and CE Marking A route-first workflow: Annex I -> Article 25 -> evidence -> CE marking. Output: technical file (Annex IV), declaration(s), and a market-ready labeling/instructions pack. Under Regulation (EU) 2023/1230, the conformity assessment route is not optional: Annex I classification and Article 25 determine whether you can use internal production control (Module A) or must involve a notified body (Modules B+C, H, or G). The fastest way to avoid expensive rework is to decide the route early and build the technical file and declarations to match that route from day one. ## 1) The route decision that matters: Annex I Part A vs Part B vs not listed Annex I categories trigger specific conformity assessment procedures. Part A categories must use Article 25(2) routes (third-party). Part B categories can use Article 25(3) routes (including Module A only under defined conditions). If the product is not listed in Annex I, Article 25(4) points to Module A (internal production control). - Part A: choose one of (B+C), H, or G (notified body involvement). - Part B: Module A only if designed/constructed per harmonised standards or common specifications for that category covering all relevant EHSR; otherwise use (B+C), H, or G. - Not listed: Module A under Article 25(4). ## 2) Article 25 procedures in plain language (what teams actually do) These modules are the 'compliance production line'. Pick the module, then build evidence and governance to fit it. Even with a notified body route, the manufacturer remains responsible for safety and evidence quality. - Module A (internal production control): you design/construct, test, compile technical file, issue DoC, affix CE mark. - Module B + C: notified body type-examines; you ensure production conforms to the examined type and control changes. - Module H (full quality assurance): quality system assessed; strong for complex/series production if implemented well. - Module G (unit verification): notified body verifies a specific unit; useful for bespoke/high-risk single machines. ## 3) Notified body implications: CE marking number and auditability When a notified body is involved in defined Article 25 procedures, the CE marking must be followed by the notified body identification number (per CE marking rules). Operational output: a clean audit trail of notified body engagement, decisions, and any conditions. - Plan notified body lead time early because Part A always needs a third-party route and many Part B families will also need one. - Freeze key hardware, software, and safety-function assumptions before assessment so the reviewed configuration is reproducible. - Keep a change-control rule set that tells you when new evidence is enough and when the notified body or route choice must be revisited. *Recommended next step* *Placement: after the main workflow section* ## Turn EU Machinery Regulation (EU) 2023/1230 Conformity Assessment and CE Marking into an operational assessment Assessment Autopilot can take EU Machinery Regulation (EU) 2023/1230 Conformity Assessment and CE Marking from turning this guidance into a repeatable review process 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 Assessment Autopilot for EU Machinery Regulation (EU) 2023/1230 Conformity Assessment and CE Marking](/solutions/assessment.md): Start from EU Machinery Regulation (EU) 2023/1230 Conformity Assessment and CE Marking and turn the guidance into owned tasks, evidence requests, and review checkpoints. - [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 Conformity Assessment and CE Marking. ## 4) Technical documentation (Annex IV): build it as an evidence system Annex IV Part A sets technical documentation minimum elements for machinery/related products. Part B covers partly completed machinery. A high-quality technical file shows how risk assessment drives protective measures and how evidence maps to essential health and safety requirements (Annex III). - Description + intended use; design drawings/schematics; explanations of operation. - Risk assessment documentation: applicable EHSR list + protective measures + residual risks. - Standards/common specs references (full/partial application noted) + alternative specs where needed. - Verification evidence: tests/inspections/examinations; production controls to ensure series conformity. - Instructions pack and, where applicable, declarations for incorporated products under other EU acts. ## 5) Declarations: DoC vs Declaration of Incorporation (and digital access obligations) Machinery and related products ship with an EU declaration of conformity. Partly completed machinery ships with a declaration of incorporation and assembly instructions. Digital delivery is allowed in defined ways, but teams must test the access conditions instead of assuming a hosted PDF is enough. - The DoC may be delivered in the instructions by internet address or machine-readable code when Article 10 allows it. - Digital instructions must be printable, downloadable, and savable, and users may request paper copies free of charge within one month. - For partly completed machinery, digital assembly instructions and the declaration of incorporation must remain accessible online for 10 years. ## 6) Practical CE release gate (what to check before placing on the market) Use this as a release checklist regardless of module. It prevents the 'surface compliance' failures that trigger market surveillance escalations. If you cannot export the evidence pack quickly, your program is not operational. - Annex I classification + Article 25 route memo approved and stored. - Risk assessment complete (Annex III general principles) and mapped to EHSR evidence. - Technical file index complete (Annex IV Part A/B) with stable filenames and versions. - Declarations issued (DoC/DoI) and translated as required; CE mark applied correctly; notified body number included when required. - Instructions/assembly instructions included (paper or digital access compliant); traceability labeling verified. ## Primary sources - [Regulation (EU) 2023/1230 corrigendum - Article 25, Annex I, and declaration rules (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2023/1230/corrigendum/2023-07-04/oj/eng?ref=sorena.io) - Primary source for Annex I route logic, conformity assessment modules, and digital declaration or instruction conditions. - [Regulation (EC) No 765/2008 - CE marking general principles (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2008/765/oj/eng?ref=sorena.io) - Primary source for CE marking general principles and placement rules. - [Regulation (EU) 2019/1020 - market surveillance (EUR-Lex)](https://eur-lex.europa.eu/eli/reg/2019/1020/oj?ref=sorena.io) - Relevant horizontal framework for compliance evidence and corrective-action follow-through. ## 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. - [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. --- [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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