CE marking explained: the complete roadmap for every company
What is CE marking ?
The letters CE stand for Conformité Européenne – European conformity. A product with the CE logo demonstrably complies with basic European safety, health, environmental and consumer protection requirements. These requirements are compiled in European directives and regulations, such as the Toy Safety Directive, the Low Voltage Directive and the Medical Devices Regulation.
CE marking does two things:
- Warranty of Conformity
The manufacturer declares in writing in the EU Declaration of Conformity that the product meets all relevant requirements. This document is legally binding and makes the manufacturer or importer liable in case of non-compliance. - Free movement of goods
With a valid CE logo, the product can be freely traded throughout the European Economic Area without additional national labels. Customs and market surveillance authorities within the EEA accept the logo as proof of conformity.
For the user, this means one clearly identifiable sign of safety and reliability. For the manufacturer, it means not only market access, but also a duty of care to keep documentation available for 10 years and to re-evaluate in case of changes.
Is CE marking mandatory for your product ?
The marking is mandatory for such things as :
- toy
- electrical and electronic devices
- medical devices
- machines
- personal protective equipment
- pressure equipment
- elevators
- building products
If your product does not fall into one of these categories, other EU legislation may apply, such as the GPSR.
Instrux’s six steps for successful CE marking
- Select legislation
Determine which EU directives or regulations cover your product. - Standards choose
Select harmonized EN standards that translate legal requirements into measurable specifications. - Inventory requirements
Conduct a risk analysis and document design, use and packaging requirements. - Product testing
Pass safety and performance tests in an accredited laboratory or internally when permitted. - Build Technical File
Collect drawings, calculations, test reports, manuals and traceable model and serial numbers. Keep this file for at least ten years. - Draw up Declaration of Conformity and affix CE logo
Sign the EU Declaration of Conformity and place the logo visibly and permanently on the product or packaging.
Check our CE marking page for more details on the CE marking steps.
Common pitfalls
- Incorrect or incomplete risk analysis
- Outdated test results or incorrectly formatted reports
- User documentation in the wrong language or with missing safety instructions
- CE logo not correctly proportioned or too small
- Unclear division of roles between manufacturer, importer and distributor
Practical tips for entrepreneurs in the Netherlands and Belgium
- Don’t blindly rely on your supplier’s documentation
- CE is all or nothing, so really take care of your documentation
- Too many model numbers on a test report is often indefensible in audit
- Your supplier is not a CE expert, so don’t take their word for it.
Why choose Instrux ?
Instrux combines in-depth product knowledge with years of practical experience. You benefit from :
- Free compliance scan – clarity on your obligations within one conversation.
- Technical-file service – all documents error-free and complete, without loss of time.
- Audit guidance – assurance and peace of mind during inspections.
Wondering how fast your product can be CE ready? Contact Instrux today : +31 85 902 4226 or email info@instrux.nl.