Some manufacturers and importers think of CE marking as an optional document — "nice to have." In reality, for product groups within scope, the CE marking is not a preference; it is a legal precondition for placing the product on the EU/EEA market. In this article we explain what selling without the CE marking really means, the sanctions that can result, and how companies manage this risk.
What Selling Without the CE Marking Really Means
The CE marking is part of the EU conformity assessment framework known as the "New Legislative Framework" (Regulation (EC) 765/2008 and Decision 768/2008/EC), and is a precondition for placing on the market for product groups within its scope. If a product falls under a directive or regulation requiring CE marking, it cannot be offered for sale, exhibited, or put into service within the EU/EEA without the marking being affixed. This rule covers not just EU-based manufacturers, but also exporters, importers and distributors sending products from outside the EU.
What does "placing on the market" mean?
"Placing on the market" is the first time a product is made available in the EU market for commercial purposes; this can be a sale, but also free distribution, rental, or, in certain circumstances, distributing samples. In other words, the CE obligation doesn't just arise at the moment of "sale" — it arises the moment the product genuinely enters circulation in the EU market for the first time. This is why the approach "I'll sell first, complete the certification later" is legally risky.
Who is held responsible?
Responsibility isn't limited to the manufacturer. As the party first bringing the product into the EU market, the importer is obligated to check whether the manufacturer correctly affixed the CE marking, and whether the technical file and EU Declaration of Conformity exist. The distributor must also exercise reasonable care to ensure the product carries the required marking. This multi-layered responsibility structure is covered in more detail in our article on a machine manufacturer's legal responsibilities.
How does market surveillance work?
Market surveillance authorities in EU member states can inspect products within scope through routine scans, import checks, consumer complaints, or accident/incident reports. During an inspection, the presence of the CE marking alone is not enough — the technical file, risk analysis, test reports and EU Declaration of Conformity behind the marking can also be requested. Knowing in advance what CE audits look at helps companies be prepared.
What sanctions can apply?
Sanctions vary according to the member state's national legislation, but typically can include: product recall or withdrawal from the market, temporary or permanent suspension of sales, administrative fines, more serious sanctions for repeated violations, and in some countries, criminal liability for serious violations. Beyond these, the lasting damage to brand reputation can often be even more costly than the administrative fine itself.
Not Just the Document — Genuine Conformity Matters
Another important point is the difference between the CE marking existing on paper and the product actually meeting the safety requirements. Inspections examine not just whether the marking exists, but whether the product was genuinely designed and tested in conformity with harmonized standards. This is why what matters is not "completing the CE marking on paper," but genuinely managing the engineering process that makes the product safe.
Relevant Directives and Standards
The CE marking obligation varies depending on the directive or regulation the product falls under: the Machinery Directive 2006/42/EC for machinery (progressively replaced by Machinery Regulation (EU) 2023/1230 from January 2027), the Low Voltage Directive 2014/35/EU for electrical equipment, 2014/30/EU for electromagnetic compatibility, the Radio Equipment Directive (RED) 2014/53/EU for wireless equipment, and the RoHS Directive 2011/65/EU for hazardous substances in electronic devices are the main pieces of legislation in this scope. All this legislation operates in line with Regulation (EC) 765/2008 and Decision 768/2008/EC, which form the application framework. See our article Which Directives Apply to My Product? to clarify which directive applies to your product.
Step by Step
- Clarify whether your product falls under CE scope.
- If it does, determine all applicable directives and regulations.
- Review the existing technical file and any previous test reports.
- Build a plan to complete any missing risk analysis, testing or documentation.
- Start the notified body process if required.
- Prepare the EU Declaration of Conformity and correctly apply the CE marking.
- Verify importer/distributor checkpoints as well, before placing the product on the market.
- Keep the file accessible for 10 years, ready for a possible inspection after the product is placed on the market.
Most Common Mistakes
- Placing a product on the market early with a "sell first, complete CE later" mindset.
- Looking at the scope of only some directives and missing other directives that apply to the product.
- Affixing the CE marking to a product without a genuine technical file and testing process behind it.
- Never questioning a supplier's CE conformity as an importer or distributor.
- Assuming the CE requirement doesn't apply to products sold through e-commerce.
- Confusing exhibition for a trade fair or as a sample with actual placement on the market.
- Delaying correcting a CE gap until an inspection or complaint arrives.
Frequently Asked Questions
Can a product be sold in the EU without the CE marking?
No. For a product group falling under CE marking scope, the CE marking is a legal requirement; placing the product on the EU/EEA market without the marking is contrary to the legislation and can be blocked by market surveillance authorities.
What kind of sanctions does a company selling a product without CE marking face?
Sanctions vary by country, but typical sanctions include the product being withdrawn from the market, sales being suspended, administrative fines, more serious sanctions for repeated violations, and corporate reputational damage.
Is a product without CE marking held at customs?
Yes, customs and market surveillance authorities can check documentation for product groups requiring CE marking; if documentation is missing or suspicious, the product can be held at customs or denied entry.
Is CE required for products intended only as prototypes or samples?
Different exceptions may apply to products not placed on the market for commercial purposes, but these exceptions are interpreted narrowly and it must be clearly documented that the product is not being offered for sale.
Does the importer take on the manufacturer's CE responsibility?
The importer has its own separate obligations: it is required to check whether the manufacturer correctly affixed the CE marking and whether the required documents exist. An importer that places a non-conforming product on the market can also be held responsible.
Is the CE requirement different for products sold via e-commerce?
No, the sales channel does not change the CE requirement. Products sold through online marketplaces are subject to the same CE requirements.
Can we affix the CE marking to a product ourselves?
The CE marking can be affixed to the product only once all the requirements are met, the technical file has been prepared, and the EU Declaration of Conformity is signed. Affixing the marking without meeting these conditions is contrary to the legislation.
What are the consequences of using an incorrect or fake CE marking?
Using the CE marking without meeting the conformity requirements is a more serious violation and can lead to more severe administrative and legal consequences; it also causes serious damage to brand reputation.
How does a market surveillance inspection begin?
Inspections can start as a result of routine scans, consumer complaints, accident reports, or checks carried out during import.
Can a product without CE marking be exhibited at trade fairs?
Generally yes, but it must be clearly stated at the stand that the product is not ready for sale; otherwise this can be treated as placing the product on the market.
If a CE gap is discovered, what can be done retroactively?
The manufacturer or importer should take corrective action immediately upon discovering the gap, recall the product if necessary, and complete the required tests/marking.
Conclusion
Placing a product on the EU/EEA market without the CE marking is not merely an administrative gap — it is a risk that can lead to serious legal and commercial consequences. Manufacturers, importers and distributors share this responsibility; the safest approach is to fully complete the scope analysis, technical file and required tests before placing a product on the market.
Contact us to clarify your product's CE status.
Get a Free Pre-Assessment