Many clients start by asking "can you get me CE certification," but CE itself isn't a single test — it's a marking framework. This article breaks down the underlying logic and goes into the specific directive numbers and practical details.
What the CE Mark Means
The CE mark indicates a product meets the requirements of relevant EU directives or regulations, and is mandatory for products entering the European Economic Area. It doesn't mean a specific body has "approved" the product — it's a manufacturer's self-declaration based on a conformity assessment.
CE Isn't One Test — It's a Combination of Directives, With Specific Numbers
To carry the CE mark, a product typically needs to meet one or more EU directives, depending on the product type. Common ones include:
- LVD, the Low Voltage Directive (2014/35/EU): electrical safety for products operating between 50-1000V AC or 75-1500V DC
- EMC Directive (2014/30/EU): electromagnetic compatibility, applicable to nearly all electrical/electronic products, covering both emissions and immunity
- RoHS Directive (2011/65/EU, amended by 2015/863): restricts hazardous substances in electrical and electronic equipment — the restricted substance count has grown from an original 6 to the current 10
- RED, the Radio Equipment Directive (2014/53/EU): applies to products with wireless functionality, replacing the older R&TTE Directive and adding new cybersecurity-related compliance requirements
- Toy Safety Directive (2009/48/EC, aligned with the EN71 series of harmonized standards): applies to toy products
Which directives apply depends on the product's function and structure — even similar products can fall under different requirements based on design. For example, the same toy, if it adds a Bluetooth remote-control function, would need to satisfy both the Toy Safety Directive and the RED simultaneously.
Self-Declaration vs. Third-Party Testing
At its core, CE relies on a manufacturer's Declaration of Conformity (DoC). In theory, some products allow manufacturers to self-assess and declare compliance. In practice, though:
- Most electrical/electronic products are still tested by third-party labs given the risk involved and buyer/platform requirements, with the test report serving as technical evidence for the declaration
- Certain high-risk categories (some medical devices, pressure equipment) legally require mandatory third-party assessment by a Notified Body
What a Declaration of Conformity (DoC) Must Actually Contain
A properly formatted declaration of conformity typically needs to include the following elements — missing any of them can render the declaration legally invalid:
- The manufacturer's name and address (and, if the manufacturer is outside the EU, the EU authorized representative's information)
- The product model, batch, or series number, sufficient to uniquely identify the product
- The full list of applicable directive numbers the declaration is based on (the specific directive numbers listed above)
- The reference numbers and versions of the Harmonized Standards relied upon
- The signatory's name, title, and date of signature
Frequently Asked Questions
Q: If I've done CE certification, do I still need EN71/LVD/EMC? A: It's the other way around. EN71, LVD, and EMC are the specific directives/standards CE compliance is based on — CE is the outcome, these are the technical basis. They're not interchangeable.
Q: Does the CE mark need to be renewed annually? A: The CE mark itself doesn't have an "expiration date," but if the product's design, materials, or applicable standards change, the declaration of conformity may need to be reassessed.
Q: Where can I find a more complete walkthrough of the CE certification process (like what the technical file needs to contain)? A: This article covers the underlying logic of CE certification — for a more detailed step-by-step process, reach out to us and we'll provide a complete guide tailored to your specific product.
If you're unsure which EU directives apply to your product before it can carry the CE mark, send us your product details for an initial assessment.