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EU Machinery Regulation Annex I conformity route

Annex I determines whether a machinery or related product falls into a listed category that changes the available conformity assessment route under Article 25.

Use this workflow to classify the product against Annex I Part A and Part B, decide whether notified-body involvement is required, and collect the evidence needed before CE marking.

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Author

Sorena AI

Published

May 9, 2026

Updated

May 9, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published May 9, 2026

Updated May 9, 2026

Overview

The Annex I route starts with product classification, not with a generic compliance checklist. Match the actual machinery, related product, safety component, embedded system, use case, and loading method against Annex I. Then apply Article 25 to select Module A, Module B plus C, Module H, or Module G, and keep the route rationale inside the technical documentation.

Section 1

Classify the product against Annex I before selecting a route

Start with the product configuration that will be placed on the EU market or put into service. Record whether it is machinery, a related product, a safety component, or partly completed machinery, then check whether any specific Union harmonisation law covers the same risks more specifically. If it does, stop the Annex I route check for those risks and use that more specific Union legislation to the extent that it applies.

If the product is in Annex I Part A, Article 25(2) applies. If it is in Annex I Part B, Article 25(3) applies. If it is not listed in Annex I, Article 25(4) points to internal production control under Module A.

Part A check: removable mechanical transmission devices and guards, vehicle servicing lifts, portable cartridge-operated fixing or impact machinery, safety components with fully or partially self-evolving machine-learning behaviour for safety functions, and machinery with embedded self-evolving machine-learning systems for safety functions.
Part B check: listed saws and woodworking machinery, presses for cold working metals with manual loading or unloading above the stated travel and speed threshold, listed plastics and rubber moulding machinery, underground-working machinery, refuse trucks with compression mechanisms, lifting devices for persons or persons and goods with a falling hazard of more than 3 m, protective devices detecting persons, listed interlocking guards, safety logic units, ROPS, and FOPS.
Scope evidence to keep: product description, intended use, foreseeable misuse assumptions, drawings or configuration records, safety-function description, software or machine-learning safety-function description where relevant, and a written Annex I match or non-match rationale.

Sources for this answer

Regulation (EU) 2023/1230 on machinery

Article 6 and Annex I identify the listed machinery and related-product categories and split them between Part A and Part B.

European Commission - Machinery sector page

Commission sector page used for machinery-policy context and links to official machinery legislation resources.

Recommended next step

Check your Annex I route before release

Turn the Annex I classification, Article 25 module selection, notified-body need, and Annex IV evidence list into a release-ready record for engineering, quality, product, and regulatory reviewers.

Research workflow

Open Research Copilot for the EU Machinery Annex I route

Answer Machinery Regulation scope, route, and evidence questions with cited outputs.

Explore next step

Talk to Sorena

Talk through the EU Machinery Annex I route

Review your Annex I classification, Article 25 route, notified-body assumptions, and technical documentation.

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Section 2

Select the Article 25 conformity assessment route

After the Annex I classification is documented, select only the route that Article 25 permits for that category. Treat the selected route as a release gate: the technical documentation, declaration, CE marking, and any notified-body certificate must align with the same route.

For Annex I Part A, self-assessment under Module A is not one of the listed options. For Annex I Part B, Module A is available only when the machinery or related product is designed and constructed according to harmonised standards or common specifications that are specific to the category and cover all relevant essential health and safety requirements.

Part A route: choose EU type-examination under Module B followed by conformity to type under Module C, full quality assurance under Module H, or unit verification under Module G.
Part B route with complete standards or common-specification coverage: Module A may be used when the category-specific harmonised standards or common specifications cover all relevant essential health and safety requirements.
Part B route without complete coverage: use Module B plus C, Module H, or Module G instead of Module A.
Not listed in Annex I: apply Module A under Article 25(4), while still documenting Annex III essential health and safety requirement coverage.

Sources for this answer

Regulation (EU) 2023/1230 on machinery

Article 25 sets the conformity assessment procedures for Annex I Part A, Annex I Part B, and non-Annex I machinery or related products.

Single Market Compliance Space - notified bodies by legislation

Commission notified-body search source for locating bodies notified under machinery legislation when Article 25 requires notified-body involvement.

Section 3

Build the evidence file around the selected route

The route decision should point directly to Annex IV Part A technical documentation for machinery and related products. The file should make clear which essential health and safety requirements apply, which protective measures meet them, which standards or common specifications were used, and which tests, inspections, calculations, or examinations verify conformity.

When software, sensor-fed operation, remote driving, autonomy, or safety-related programming is relevant, include the documentation Annex IV calls out for source code or programming logic, and for the system characteristics, capabilities, limitations, data, development, testing, and validation processes.

Classification record: Annex I Part A, Annex I Part B, or not listed, with the product facts that support the conclusion.
Route record: Article 25 paragraph and module selected, including the standards or common specifications relied on for a Part B Module A route.
Technical documentation: product description, intended use, risk assessment, applicable EHSRs, protective measures, residual risks, drawings, standards or technical specifications, verification reports, production conformity controls, instructions for use, incorporated-product declarations, and series-production controls.
Notified-body evidence where used: application package, certificate or approval decision, unit-verification certificate where applicable, notified-body identification number handling for CE marking, and change or state-of-the-art review records for certificates.

Sources for this answer

Regulation (EU) 2023/1230 on machinery

Annex IV Part A lists the technical-documentation contents and Articles 10, 21, 24, and 25 connect the file to declaration, CE marking, and conformity assessment.

ISO 12100:2010 safety of machinery standard page

ISO source used only as machinery risk-assessment context, not as a claim that a specific edition is harmonised for every Annex I category.

Primary sources

References and citations

European Commission - Machinery sector page

single-market-economy.ec.europa.eu

Referenced sections

Commission sector page used for machinery-policy context and links to official machinery legislation resources.

"EU machinery legislation"

ISO 12100:2010 safety of machinery standard page

iso.org

Referenced sections

ISO source used only as machinery risk-assessment context, not as a claim that a specific edition is harmonised for every Annex I category.

"Safety of machinery"

Regulation (EU) 2023/1230 on machinery

eur-lex.europa.eu

Referenced sections

Annex IV Part A lists the technical-documentation contents and Articles 10, 21, 24, and 25 connect the file to declaration, CE marking, and conformity assessment.