CE marking is required for electronics, toys, PPE, medical devices, and many other products in the European Union. Manufacturers have certain obligations when it comes to ensuring that their products are safe, tested, documented, and correctly labeled.
In this guide, we explain what manufacturers are required to do in order to ensure compliance with one or more CE marking directives – and what the consequences of failing to do so might be.
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CE Marking Basics
I recommend that you start by reading these articles if you are new to CE marking requirements:
- List of CE Marking Directives and Regulations: An Overview
- Declaration of Conformity (DoC) Requirements For Importers & Amazon Sellers
- Technical File Requirements for CE Marked Products in the EU
- Harmonized Product Standards in the European Union: An Overview
- CE Marking and Product Lab Testing: A Complete Guide
What is the definition of a manufacturer?
This is the definition from Article 2 in the Low Voltage Directive:
(3) ‘manufacturer’ means any natural or legal person who manufactures electrical equipment or has electrical equipment designed or manufactured, and markets that equipment under his name or trademark;
As such, manufacturers cover both companies that operate their own production facilities – for example, contract manufacturers in China. It also includes companies buying custom-designed and private label products manufactured by other companies.
Other Directives
Similar definitions can be found in the other directives, such as the following:
- Toy Safety Directive
- RoHS Directive
- EMC Directive
- Radio Equipment Directive
- Personal Protective Equipment Directive
What are the CE marking responsibilities of a manufacturer?
You can find manufacturer obligations in Article 6 of the Low Voltage Directive. Here are some of the most important points:
1. Manufacturers are responsible for ensuring that the product is designed according to applicable safety standards and requirements
2. Manufacturers must create a Declaration of Conformity
3. Manufacturers must create a technical file
4. Manufacturers must be able to provide a test report (to demonstrate that a conformity assessment process has been followed)
5. Manufacturers must ensure that the product and packaging is correctly labeled (e.g. CE mark, SKU, manufacturer identity, contact details, batch/serial number)
6. Manufacturers must create a user manual/instruction (in the relevant national languages)
In short, manufacturers are obliged to manage the conformity procedure. This often includes the following steps:
Process
1. Confirm applicable EN standards
2. Ensure that the design of the product is compliant with applicable standards
3. Create a technical file
4. Create a Declaration of Conformity
5. Arrange third-party lab testing
6. Create label files and ensure that these are applied correctly to the product and the packaging
7. Write and print user instructions
Some products, such as PPE and medical devices, also require the involvement of a notified body.
Can importers be classified as manufacturers?
Yes, the manufacturer definition is not limited to companies that operate their own production facilities. The Low Voltage Directive, explicitly mentions any natural or legal person that “has electrical equipment designed or manufactured, and markets that equipment under his name or trademark”.
This means that companies outsourcing their own product designs to contract manufacturers are also considered being manufacturers. This is the case even if you buy products designed by the factory – but apply your own brand name.
As such, EU companies importing custom-designed and private label products on Alibaba.com are therefore manufacturers – and are therefore fully responsible.
What kind of documents do manufacturers need to provide to EU importers?
Importers are responsible for verifying that products are compliant, correctly labeled, and documented. Here are some of the documents you should share with an EU customer asking for compliance documentation:
1. Declaration of Conformity (DoC)
2. User instructions
3. Technical file
4. Lab test reports
5. Label photocopies
Do non-EU manufacturers need to comply with CE marking requirements?
In practice, it’s up to the importer in the European Union to check that the product is compliant, correctly labeled, and documented. That being said, there are two scenarios in which non-EU manufacturers can benefit from ensuring compliance with all CE marking requirements.
B2B Export Sales
EU importers can only purchase your products if they are compliant with all applicable directives and regulations. Hence, ensuring compliance with all CE marking requirements gives you an edge over your competitors.
The alternative is that your prospective buyers must create label files, and documents and pay for lab testing. This can be done but can be costly if each buyer must repeat the same process for the same product.
B2C Cross-Border Sales
Products covered by one or more “CE marking directives” shipped directly to consumers in the EU must be labeled with the details of an Authorized Representative. There are many companies in the EU acting as Authorized Representatives for an annual fee.
These companies in turn also have certain obligations, including checking that your products are compliant. Again, this means that you’ll need to provide test reports, DoC, and other documents supporting that your products are compliant.
What can happen if a manufacturer exports non-CE-marked products to the EU?
Exporting non-compliant products to the EU can have severe consequences for both manufacturers and their EU-based buyers. Here are some scenarios to take into consideration:
Customs issues
National customs authorities routinely check if products in inbound shipments are compliant – especially for more ‘high risk’ products such as electronics, toys, and medical devices. Failing to provide mandatory documentation – often a lab test report and Declaration of Conformity – can result in the shipment being rejected and sent for destruction.
Product recall
National market surveillance authorities can make product compliance inquiries weeks or months after a certain product has been imported and placed on the EU market. They tend to request lab test reports and a DoC to demonstrate compliance. Failing to provide these documents can result in a product recall or sales ban.
Market surveillance authorities also act in case the product is reported by consumers. Further, there are also instances in which the authorities secretly buy products from online stores – only to have them sent to their own safety testing labs.
In short, ensuring CE marking compliance goes beyond “getting through the customs check”.
Authorized representative
The customs have the right to remove parcels shipped directly to consumers in the EU, in case the packaging lacks Authorized Representative information.
