CE marking is the manufacturer's declaration that a product meets EU safety, health, and environmental requirements. It is mandatory for a wide range of products before they can be sold in the European Economic Area (EEA).
Step 1: Identify Which Directives Apply
A single product can fall under multiple EU directives simultaneously. Common ones include:
- Machinery Directive (2006/42/EC) — for machines and safety components
- Low Voltage Directive (2014/35/EU) — for electrical equipment 50–1000 V AC
- Radio Equipment Directive / RED (2014/53/EU) — for all wireless devices
- EMC Directive (2014/30/EU) — for all electrical/electronic products
- RoHS Directive (2011/65/EU) — hazardous substances in electronics
Step 2: Identify Applicable Harmonised Standards
Each directive lists harmonised EN standards in the Official Journal of the EU. Products tested and found to comply with these standards benefit from a "presumption of conformity" — meaning regulators presume you meet the directive requirements.
NormScout automates this lookup: input your product category and get the relevant standard list instantly.
Step 3: Conformity Assessment
Most products allow self-certification (internal production control). Some high-risk categories (e.g. certain machinery, PPE) require a Notified Body to conduct a third-party assessment.
| Risk Level | Assessment Route | Notified Body Required? |
|---|---|---|
| Low / Standard | Internal production control | No |
| Medium | EU-type examination + internal control | Sometimes |
| High | Full quality assurance / type examination | Yes |
Step 4: Technical Documentation
Compile your Technical File (TF). This must include:
- Product description and intended use
- Design drawings and component list
- List of applicable directives and standards
- Test reports confirming compliance
- Risk assessment
- Instructions for use (in all required languages)
Step 5: Draw Up the Declaration of Conformity
The Declaration of Conformity (DoC) is a legal document signed by the manufacturer. It must list the product, all applicable directives, and reference the relevant standards. See our full DoC guide for a ready-to-use template.
Step 6: Affix the CE Mark
The CE mark must appear on the product itself, or on its packaging or accompanying documents if affixing to the product is not possible. The minimum height is 5mm. It must be visible, legible, and indelible.