CE Marking Responsibilities for Importers: A Complete Guide

Planning to import electronics, toys, protective equipment, or medical devices to the European Union? If yes, then you need to ensure that your imported products are correctly CE marked. However, CE marking is far more complex than simply affixing the compliance mark itself.

In this guide, I explain the CE marking process, including risks and common misconceptions, when importing products to the European Union.

CE Marking Basics

CE marking is mandatory when placing certain products on the market in the EU. As such, CE marking is applicable both to products imported from outside the EU, for example, China, or manufactured within the EU.

In short, CE marking signals whether a product is compliant with one or more directives or regulations. Here are some examples:

• Toy Safety Directive
• RoHS Directive
• Low Voltage Directive
• EMC Directive
• Personal Protective Equipment Directive

CE marked products must also be supported by documentation, including some sort of lab test report or assessment. As such, printing a CE mark and calling it a day is not sufficient.

In order for a product to be compliant, the following must be completed:

• Product lab testing
• Product and packaging labeling
• Declaration of Conformity (DoC)
• Technical file
• User instructions

Importer Responsibilities

First, we need to look at the definition of an importer. Here’s the definition from the Toy Safety Directive:

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‘Importer’ means any natural or legal person established within the Community who places a toy from a third country on the Community market;

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Responsibilities

The directive also lists the various responsibilities of importers:

a. Importers must check the Declaration of Conformity (DoC)

b. Importers must check if the product is correctly CE marked

c. Importers must ensure that the manufacturer has the mandatory technical documentation

d. Importers must ensure that a conformity assessment procedure has taken place (e.g. lab testing)

e. Importers must ensure that the product has user instruction, in the national language of the EU member state in which the product will be sold

f. Importers must indicate their company name on the product (if possible), packing and user instructions

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The emphasis is for importers to verify if the manufacturer has ensured that the product is compliant. In practice, this involves the following steps:

• Verifying lab test reports
• Reviewing DoC and technical file
• Reviewing user instructions
• Reviewing product and packaging labels

Manufacturer Responsibilities

Many importers in the EU are in fact classified as manufacturers without knowing it. Here’s the definition of a manufacturer in the Toy Safety Directive:

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‘Manufacturer’ means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under his name or trademark;

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As such, any importer that contracts the manufacturing of a custom-designed or private label product to a manufacturer outside the EU is therefore considered a manufacturer – not an importer. Many small businesses buying products with their logo from suppliers on Alibaba.com are seen as manufacturers.

Responsibilities

The responsibilities of a manufacturer go beyond those of an importer:

1: Manufacturers must create a DoC and affix the CE mark to the products

2: Manufacturers must arrange lab testing to verify that the product is compliant

3: Manufacturers must create technical documentation

4: Products and packaging must be labeled with the product name, model, SKU, batch ID serial number of other information necessary for identification.

5: Product packaging must include the manufacturers’ name, address, and contact details.

6: Manufacturers must create user instructions, in the language of the EU member state in which the product will be sold

7: Manufacturers must ensure that the test reports, documents, and labels are kept up to date in case product changes are made. This includes making changes to functionality, design, or materials.

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Rather than verifying and reviewing existing documents and files – manufacturers must manage the compliance process hands-on:

• Book lab testing
• Create DoC
• Write technical file
• Write user instructions
• Create product and packaging label files

Importing custom designed products

Companies importing products manufactured based on their design are considered manufacturers – even if they themselves don’t operate any production facility. As such, you assume the responsibilities of a manufacturer when importing custom-designed products.

Further, it’s necessary to assess applicable harmonized standards before you submit a product specification to the overseas factory. Otherwise, you run the risk of mass-producing a product that is inherently non-compliant.

You should not expect any assistance from your overseas manufacturer when it comes to the CE marking process. It’s entirely up to you to create label files, DoC, technical documentation, and user instructions.

Custom Designed & Private Label Products

Likewise, importers that purchase products with their logo, brand, or trademark also take on the responsibilities of a manufacturer. This is the case even if the product is fully designed by the original manufacturer, rather than the importer.

Even in this case, you should not expect any compliance support from the actual manufacturer. You will need to create label files (including the CE mark), arrange third-party lab testing, and draft the documentation – even if you import private label products.

Lab testing

Importers are responsible for assessing if a product is compliant, which can involve the verification of existing lab test reports. In practice, however, it’s extremely rare that non-EU suppliers can provide valid and verifiable lab test reports for their products. This is the case even for factory-designed products.

As such, EU importers must usually arrange third-party lab testing in order to verify if the product is in fact compliance.

Custom Designed & Private Label Products

Companies importing custom-designed or private label products cannot use pre-existing lab test reports for products that are yet to be manufactured.

CE Mark & Labeling

Importers are required to ensure that the product “bears the required conformity marking” – in other words, the CE mark. Further, labeling requirements also cover product and importer information.

In practice, however, EU importers must often create their own CE mark label files and submit these to their suppliers.

Custom Designed & Private Label Products

Importers buying custom-designed or private label products must also create a complete CE label file. Further, keep in mind that you must also include product and importer information on the product and the packaging.

Declaration of Conformity (DoC)

EU importers are required to check the suppliers’ Declaration of Conformity. Again, it’s highly unlikely that your supplier in China or Vietnam even knows what a DoC is, and even less so being able to provide one. This is the case even for factory-designed products.

In practice, EU importers must either issue their own DoC or instruct the supplier on how to create one.

Custom Designed & Private Label Products

Likewise, companies importing custom-designed or private label products must also self-issue the DoC. This is also clear under the manufacturer’s obligations.

Technical file

The technical file generally consists of the design drawings, bill of materials, wiring diagrams, label files, packaging artworks, and a risk assessment. Importers “shall ensure that the manufacturer has drawn up the technical documentation”. In practice, doing so is extremely difficult for two reasons:

a. Most manufacturers outside the EU usually don’t have a technical file

b. Even if they did, they rarely share the technical file as it is their intellectual property

We have verified hundreds of manufacturers in Asia on behalf of EU importers over the years. Not once have we received a complete and correct technical file.

Instead, importers must often recreate their own technical file by ‘reverse-engineering the product. In short, create their own design drawings, bills of materials, and other documents.

Custom Designed & Private Label Products

Manufacturers, which includes importers of OEM and ODM products, must on the other hand create their own technical documentation from scratch.

User Manual

Importers must ensure that the product is “accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned”.

In short, you need a user manual in Polish if you sell in Poland, and one in Danish if you sell in Denmark.

The chance that your average Alibaba supplier can actually provide a user manual – in any language – is slim. When it comes to European languages other than English, it’s non-existent.

Again, in practice, it falls on the importer to create user instructions, in the necessary languages. The factory can print the user instruction and place them in the product packaging, but that’s about as far as they are involved in this matter.

Custom Designed & Private Label Products

Companies importing custom-designed or private label products are seen as manufacturers and must also create their own user instructions file.

FAQ

Are importers responsible for CE marking?

Yes, importers based in the EU are responsible when ordering products from suppliers outside the EU. This responsibility cannot be shifted to the overseas supplier.

The obligations primarily emphasize assessing if the existing product is compliant. Yet, the chance of finding a fully compliant product on Alibaba.com or other websites listing non-EU suppliers is slim.

It’s therefore common that importers must practically manage the compliance process on the suppliers’ behalf.

Keep in mind that the importer practically assumes all the risk if something goes wrong. It’s highly unlikely that you can successfully return non-compliant products to suppliers outside the EU, or receive any form of compensation for that matter

What kind of documents do I need from my supplier?

You should start by requesting the suppliers’ lab test report and Declaration of Conformity (DoC). Other than that you’ll also need to either review the following:

• Technical file
• User instructions
• Packaging artwork
• Product labels
• Product photocopies

As mentioned, chances are slim that your supplier can provide a complete set of lab test reports, DoC, and other files.

Keep in mind that this is only applicable if you purchase factory-designed products. The process is entirely different when custom-designed products are manufactured.

What can I do if my supplier doesn’t have the correct CE documents?

The first thing you need to consider is whether you need to arrange third-party lab testing. It’s pointless to spend time creating compliance documents and label files for a product that is technically non-compliant by design.

You can then proceed to create the remaining documents and label files, such as the DoC, and technical file.

Is it enough if my product is CE marked but not documented?

No, a CE mark by itself is worthless unless you can provide the necessary documentation, meaning DoC, test report, technical file, and user instructions. National market surveillance authorities in EU member states are also aware of the fact that many importers purchase goods that carry the CE mark – but are not technically compliant and documented.

The presence of the CE mark itself will not protect your business in case of a product recall, fines, or other action.

How do I prove that my imported product is correctly CE marked?

Retailers and national market surveillance authorities generally require that you can provide a Declaration of Conformity and supporting lab test reports. They may also request the following:

• Product label photos
• Packaging artwork files
• User instructions

However, it is relatively rare that they request technical files, as these tend to include sensitive product information. I can imagine that they would request the technical file in case of death or injury – which can require a more thorough investigation of the design and construction of the product.

What can happen if I import products that are not correctly CE marked?

Your business and products can be subject to a sales ban, fines, or recalls. It’s illegal to import and sell products that are not correctly CE marked and documented – assuming the CE mark is required for said product.

Don’t expect the overseas manufacturer to offer any compensation or other assistance in case your products are subject to the actions described above.

Do I need to ensure compliance if similar products are already sold in the EU?

The fact that other importers are buying similar or even the exact same products – from the very same overseas manufacturer – does not relieve you of the importer obligations.

Products that look similar or even exactly the same on the outside may still be designed using different components and materials. This is the case even if the products are made in the same factory.

There are no shortcuts when it comes to CE marking for importers. You simply have to ensure that the product is correctly documented and labeled.

Why can’t I rely on my supplier to provide the required documentation?

Various CE marking directives often state that the importer should ensure that the manufacturers’ product is correctly documented – this does not reflect reality. Manufacturers in Asia, and other regions, are not experts in EU compliance. It’s simply not their area of expertise.

It would also not be realistic to expect an OEM or ODM manufacturer to absorb all the costs involved with the CE marking process, only for them to sell the product at a factory price.

Manufacturers and brands that have reached that level of sophistication, such as Xiaomi from China, are certainly not selling their products at factory prices. Instead, they operate their own importing and distribution in the European Union.

It falls on you as an EU importer to understand the CE marking process and ensure that it’s correctly implemented.

This is the case regardless of whether you resell products from another brand, or have your own custom-made or private label product manufactured overseas.