What does CE marking mean?
CE marking is not a test seal but a declaration by the manufacturer: the machine meets all EU harmonisation legislation that applies to it. Without CE marking, machinery may not be placed on the market in the European Economic Area.
From 20 January 2027 the Machinery Regulation (EU) 2023/1230 is the key legislation for machinery. Depending on the equipment, other acts may apply too – such as the EMC Directive, the Radio Equipment Directive or, for connected products, the Cyber Resilience Act.
The process in 7 steps
1. Determine the applicable legislation
Is the product machinery, partly completed machinery or a safety component? Which other EU rules apply?
2. Carry out the risk assessment
Identify hazards across all lifecycle phases, evaluate and reduce risks – in the order: inherently safe design, technical protective measures, information for use. EN ISO 12100 is usually the basis.
3. Meet the essential requirements
The essential health and safety requirements are in Annex III of the Machinery Regulation. Applying harmonised standards gives a presumption of conformity.
4. Compile the technical documentation
Description, drawings, risk assessment, standards applied, test reports, instructions – to be kept for at least 10 years.
5. Carry out the conformity assessment procedure
For most machinery, internal production control by the manufacturer is sufficient. For machinery listed in Annex I a notified body must be involved – depending on the category and on whether harmonised standards are applied.
6. Draw up the EU declaration of conformity
The manufacturer declares conformity with all applicable legislation in writing. The declaration accompanies the machine or is accessible via an internet address stated in the instructions.
7. Affix the CE marking and supply the instructions
The marking is affixed visibly, legibly and indelibly. The instructions accompany the machine – on paper or digitally.
Special case: partly completed machinery
Partly completed machinery – such as assemblies integrated into a plant at the customer site – does not receive CE marking. Instead, the manufacturer issues a declaration of incorporation and supplies assembly instructions. CE marking follows later for the complete machine.
The documents at a glance
| Document | Recipient | Retention |
|---|---|---|
| Risk assessment | internal / market surveillance | at least 10 years |
| Technical documentation | internal / market surveillance | at least 10 years |
| EU declaration of conformity | customer | at least 10 years |
| Instructions for use | customer | digital: at least 10 years online |
| Declaration of incorporation + assembly instructions | customer (partly completed machinery) | at least 10 years |
Managing CE documentation efficiently
Most documents are based on the same product data: BOM, assemblies, images, technical data. Generated from one source, they stay consistent – across variants and revisions. With proquodo, instructions, parts lists and other documents are created straight from CAD, PDM and ERP, versioned per machine.
Note: this article provides an overview and does not replace legal advice or a case-by-case conformity assessment.
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