ScopeEU

EU Machinery Regulation (EU) 2023/1230 Scope and Machine Categories

Classify product type, exclusions, and Annex I categories fast.

Focus: defensible scope memos and correct Article 25 route selection.

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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

Scope work is a compliance multiplier: it determines whether you need an EU Declaration of Conformity or a Declaration of Incorporation, what technical documentation applies (Annex IV Part A vs Part B), and whether Article 25 triggers notified body involvement. This page turns the Regulation's scope logic into an execution guide you can reuse across product families.

Section 1

1) What the Regulation covers (product types in scope)

The Regulation applies to machinery and specific 'related products' (and also to partly completed machinery).

Operational output: every product family should be labeled as one of these types in the technical file index.

Machinery (including assemblies and assemblies missing only the upload of software intended for the specific application foreseen by the manufacturer).
Related products: interchangeable equipment, safety components (including software), lifting accessories, chains/ropes/webbing, removable mechanical transmission devices.
Partly completed machinery: assemblies intended to be incorporated into or assembled with machinery.

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Section 2

2) The biggest scope traps (and how to avoid them)

Scope disputes usually happen for three reasons: the product is actually excluded, the product is an electrical product covered by LVD/RED, or the product is a safety component/software sold independently.

Control: require a scope memo and an 'exclusions checked' section before any conformity testing begins.

Electrical product exclusions: certain household appliances, A/V, IT, office machinery, low-voltage switchgear/control gear, and electric motors when within LVD/RED scope.
Research-only temporary laboratory machinery: excluded.
Transport regimes: aircraft/water/rail and vehicle regimes (except machinery mounted on them).
Spare parts: safety components supplied as spare parts to replace identical components can be excluded in specific conditions.

Section 3

3) Machinery vs partly completed machinery (evidence and declaration implications)

This classification changes your required declarations, documentation, and customer-facing obligations.

Treat it as a primary decision in your product compliance architecture.

Machinery/related products: CE marking, EU Declaration of Conformity, technical documentation (Annex IV Part A).
Partly completed machinery: EU Declaration of Incorporation, assembly instructions, technical documentation (Annex IV Part B).
Digital publication obligations can apply (e.g., online access to instructions/declarations for defined periods).

Section 4

4) Annex I categories: why they matter

Annex I lists categories that trigger specific conformity assessment routes. Part A categories require third-party procedures (Article 25(2)). Part B categories can use routes in Article 25(3) - including Module A only under defined conditions.

Operational output: a classification note that cites the exact Annex I category item(s) that match.

Part A includes, among others, removable mechanical transmission devices and certain self-evolving ML safety components/systems ensuring safety functions.
Part B includes many high-risk categories (woodworking saws, presses, lifting of persons, protective devices, logic units for safety functions, etc.).
Not in Annex I: default route is internal production control (Module A) under Article 25(4).

Section 5

5) Output artifacts to standardize across teams

A repeatable scope bundle prevents rework during audits and notified body interactions.

Build once per product family and update on changes.

Scope memo: product type + exclusions checked + applicable legislation list.
Annex I classification note + Article 25 route decision memo.
Initial risk assessment outline (Annex III general principles) and planned evidence pack index (Annex IV).

Primary sources