ChecklistEU

EU Machinery Regulation (EU) 2023/1230 Checklist

A CE marking readiness checklist you can run before release.

Each item should have an owner, evidence link, and acceptance criteria.

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Author

Sorena AI

Published

Feb 21, 2026

Updated

Feb 21, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 21, 2026

Updated Feb 21, 2026

Overview

This checklist is designed to survive real audits and market surveillance requests. Use it per product family and link each checklist item to an evidence ID and file path in your Annex IV technical file index.

Section 1

A) Scope and product type classification (Article 2-3)

Scope mistakes cause the biggest rework. Document this once and reuse it.

Product type labeled: machinery vs related product vs partly completed machinery vs safety component/software.
Exclusions checked and documented with rationale (transport regimes, research-only lab use, specified electrical products under LVD/RED, etc.).
Economic operator roles confirmed (manufacturer/importer/distributor/authorised representative).
Substantial modification policy defined (what changes trigger re-assessment).

Section 2

B) Annex I classification and Article 25 route decision

Route selection determines notified body involvement and how CE marking is applied.

Annex I category decision memo stored (Part A / Part B / not listed) with exact category references.
Article 25 procedure selected and documented (Module A vs B+C vs H vs G).
If Part B + Module A used: evidence that harmonised standards/common specs for that category cover all relevant EHSR and are applied.
Notified body engagement plan created where required (lead time, scope, change control triggers).

Section 3

C) Annex III risk assessment and safety integration (the safety case)

Risk assessment is mandatory and iterative; controls must follow the safety integration hierarchy.

Limits defined (intended use + foreseeable misuse + lifecycle phases).
Hazards and hazardous situations identified; risk estimation/evaluation documented.
Protective measures selected in priority order (inherently safe design -> protective measures -> information).
Residual risks documented and mapped to warnings/marking/instructions.
Special cases covered: autonomy/self-evolving behavior, interaction between machines, planned software updates.

Section 4

D) Annex IV technical documentation (Part A or Part B) and evidence indexing

Your technical file must be exportable and reviewable. Build a stable index and link evidence.

Technical file index complete (scope memo, route memo, EHSR list, evidence map).
Design drawings/schematics + operation explanations stored and versioned.
Standards/common specifications register + partial application clause mapping maintained.
Verification evidence complete: test reports, inspections, examinations, calculations.
Series production controls documented (how you keep production conforming).
Instructions pack included (and assembly instructions + DoI for partly completed machinery).
Software/control-system evidence ready where relevant (safety software identification, intervention logs, reasoned-request bundles).

Section 5

E) Declarations, CE marking, and traceability

These are the first things checked. Treat missing or inconsistent artifacts as release blockers.

EU Declaration of Conformity issued for machinery/related products; kept updated; translated as required.
EU Declaration of Incorporation issued for partly completed machinery; assembly instructions provided; digital access compliance implemented if used.
CE marking affixed visibly/legibly/indelibly (or packaging/docs if necessary); affixed before placing on market/putting into service.
Notified body identification number follows CE marking where required by the applied procedure.
Traceability labels and contact details verified on product/packaging/accompanying documents.

Section 6

F) Transition and compliance calendar (plan for 14 Jan 2027)

Transition work is a project: route decisions, standards strategy, documentation modernization, and supplier alignment.

Transition plan created (Directive 2006/42/EC -> Regulation 2023/1230) with milestones and owners.
Notified body capacity planning for Annex I categories that require third-party procedures.
Digital instructions/declarations strategy defined (accessibility, print/download, retention).
Penalty rules monitoring and market surveillance readiness tested (response pack export).

Recommended next step

Turn EU Machinery Regulation (EU) 2023/1230 Checklist into an operational assessment

Assessment Autopilot can take EU Machinery Regulation (EU) 2023/1230 Checklist from turning this checklist into an operational workflow 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.

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