ApplicabilityEU

EU Machinery Regulation (EU) 2023/1230 Applicability Test

Decide scope, Annex I category, and conformity route - with defensible reasoning.

Output: a scope memo + route decision + technical file plan per product family.

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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

Most compliance failures start with a bad classification: the product type (machinery vs partly completed machinery vs safety component), an overlooked exclusion, or a missed Annex I category that changes the conformity assessment route. This page gives you a practical, reviewable decision sequence that teams can run quickly and repeatably.

Section 1

Before you start: capture the minimum product facts

A defensible scope outcome requires stable product facts. If you can't answer these, pause and collect the data before you start testing or drafting declarations.

Output: a one-page scope memo per product family.

What is being placed on the market: complete machinery, related product, safety component (physical/digital), or partly completed machinery?
Intended use + reasonably foreseeable misuse; lifecycle phases (transport, assembly, maintenance, dismantling).
Energy source and moving parts; control system architecture (software, sensors, remote control, autonomy).
How it is supplied: standalone vs integrated; installed on a vehicle/vessel/aircraft? used in a nuclear installation?
Who is the manufacturer/economic operator (including branding and any substantial modifications)?

Section 2

Step 1 - Is it within the product scope (machinery + related products + partly completed machinery)?

The Regulation covers machinery and specific related products (e.g., interchangeable equipment, safety components, lifting accessories, chains/ropes/webbing, removable mechanical transmission devices) and also partly completed machinery.

Operational control: explicitly label the product type in your scope memo and technical file index.

Machinery can include assemblies missing only the uploading of software intended for the specific application foreseen by the manufacturer.
Safety components can be physical or digital (including software) if they perform a safety function and are independently placed on the market.
Partly completed machinery is not yet machinery and is intended to be incorporated into or assembled with machinery.

Section 3

Step 2 - Check exclusions (don't assume you are in scope)

The Regulation does not apply to several categories (e.g., fairground equipment, weapons, certain transport means, research-only temporary lab machinery) and it excludes specified electrical/electronic products insofar as they fall under LVD/RED.

Control: keep an 'exclusions checked' section in the scope memo with 1-2 sentence rationales.

Transport: means of transport by air/water/rail (except machinery mounted on them) and certain vehicle regimes.
Research-only: machinery specially designed and constructed for research purposes for temporary use in laboratories.
Electrical/electronic products: certain household appliances, A/V, IT, office machinery, low-voltage switchgear/control gear, and electric motors (when they fall under LVD/RED).

Section 4

Step 3 - Annex I classification: Part A vs Part B (changes the Article 25 route)

Annex I lists categories of machinery or related products subject to specific conformity assessment routes. Part A categories require procedures under Article 25(2) (third-party routes). Part B categories can use Article 25(3) routes (including Module A in certain conditions).

Operational output: an Annex I classification note that cites the exact category item (and sub-item) you match.

Part A examples include removable mechanical transmission devices and certain ML/self-evolving safety components and embedded safety systems.
Part B includes many high-risk machinery categories (e.g., various saws, presses, lifts, protective devices, logic units).
If you are not in Annex I, Article 25(4) points you to internal production control (Module A).

Section 5

Step 4 - Article 25 conformity assessment route (Module A vs notified body routes)

Once Annex I status is known, you can choose the correct route: Module A for non-Annex I (and for some Annex I Part B conditions), or notified body routes (Modules B+C, H, or G) for Annex I categories and for Part B cases that do not meet the 'harmonised standards/common specs fully cover' condition.

Control: keep a "route decision memo" that references Article 25 paragraph and the evidence you will build.

Annex I Part A: one of the procedures in Article 25(2) (B+C, H, or G).
Annex I Part B: Module A only if designed/constructed per relevant harmonised standards or common specifications covering all relevant EHSR for that category; otherwise use (B+C), H, or G.
Notified body involvement means CE marking is followed by the notified body identification number (per CE marking rules).

Section 6

Step 5 - Substantial modification: when you become the 'manufacturer' again

If a product is modified after being placed on the market/put into service in a way that affects safety (creating a new hazard or increasing risk) and is not foreseen by the original manufacturer, it can trigger substantial modification duties.

Operational output: a modification impact review that decides whether a new conformity assessment under Article 25 is needed.

Capture modifications by physical or digital means (including software/config changes).
Assess if new hazards are introduced or existing risks increase.
If substantial: treat the modifier as responsible for conformity and route application.

Section 7

If 'in scope': the next three artifacts to build

Once the Regulation applies, move directly to the evidence chain: risk assessment -> technical documentation -> declaration(s) -> CE marking/availability requirements.

Use the linked pages to convert this into an execution plan.

Risk assessment method (Annex III general principles) + hazard log.
Technical file index aligned to Annex IV (Part A or Part B).
Conformity assessment route workflow (Article 25) + DoC/DoI + CE marking controls.

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