CE MarkingEU

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.

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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

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.

Section 1

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).

Section 2

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.

Section 3

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.

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Section 4

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.

Section 5

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.

Section 6

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