EU CE Marking
The mandatory compliance mark for products placed on the EU and EEA market, covering LVD, EMC, machinery, toys, medical devices and construction products.
What is EU CE Marking?
The CE mark is the mandatory compliance mark for products entering the EU and EEA, showing that the product meets the applicable EU directives and regulations.
Before affixing the CE mark, the manufacturer must complete conformity assessment, compile a technical file (TCF), sign a Declaration of Conformity (DoC), and ensure nameplate, instructions and packaging information are complete.
Some higher-risk products (certain machinery, medical devices) require a Notified Body and its certificate; most electrical and electronic products can be self-declared.
Applicable products
- Electrical & electronics (LVD/EMC)
- Toys
- Machinery
- Medical devices
- Construction products
Application process
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01
Determine directives and harmonised standards
Identify the applicable directives and EN harmonised standards based on product function, voltage and use.
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02
Testing
Complete safety and EMC testing against harmonised standards and obtain test reports.
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03
Compile the technical file (TCF)
Assemble drawings, BOM, instructions, risk assessment and test reports into a complete technical file.
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04
Sign the DoC and affix CE
Issue the Declaration of Conformity, affix the CE mark on the product or packaging, and retain the technical file.
Required documents
- Product specification and intended use
- Circuit diagrams, structure drawings or exploded views
- BOM with critical component models and certification details
- Test reports (EN standards)
- Instructions, warnings and nameplate artwork
- Draft Declaration of Conformity (DoC)
- Notified Body certificate (if applicable)
| Directive / regulation | Scope |
|---|---|
| LVD 2014/35/EU | Low Voltage Directive, for equipment rated 50–1000 V AC / 75–1500 V DC |
| EMC 2014/30/EU | Electromagnetic Compatibility Directive, limiting emissions and ensuring immunity |
| MD 2006/42/EC | Machinery Directive, for machinery and interchangeable equipment |
| 2009/48/EC | Toy Safety Directive, covering physical, chemical and electrical safety |
| MDR (EU) 2017/745 | Medical Device Regulation, risk-based classification |
| CPR (EU) 305/2011 | Construction Products Regulation, declaration of performance and CE marking |
FAQ
Is CE marking mandatory?
Yes. Products within the scope of a directive cannot be sold in the EU without the CE mark, and customs may detain them.
Do I always need a Notified Body?
No. Most electrical and electronic products can be self-declared; machinery, medical devices and other higher-risk categories require a Notified Body.
Does a CE certificate expire?
There is no single "certificate validity" for CE, but technical files and test reports must stay aligned with current standards and be reassessed when standards change.
Who signs the DoC?
The manufacturer or its EU authorised representative, who bears legal responsibility for conformity.
Send the product name, model and destination country and our consultant will map the certification route and quote.
Related compliance documents
Application forms, contracts and procedure documents are available for free in the client center
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