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.

While importers are not responsible for the actual CE marking of products, they are responsible for verifying that the manufacturer has fulfilled their CE marking requirements.

In practice, this means that importers must obtain documentation, test reports, label files, and validate these before importing CE-marked products to the EU.

Key points

• Importers are companies based in the EU introducing products from non-EU suppliers
• Importers can also be defined as manufacturers
• Importers must obtain and verify documents, test reports, and labels
• Importing incorrectly CE-marked products can result in recalls

Are you defined as an importer?

Importers are generally defined as the first EU entity which introduces products from outside the EU. However, not all companies importing products are defined as only importers and therefore subject to importer obligations.

It is therefore critical that you first work out whether you truly are defined as an importer within the context of CE marking, or you might actually be defined as a manufacturer.

To understand what an importer is, we need to look at the definition. The following can be found under the PPE Regulation:

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‘importer’ means any natural or legal person established within the Union who places PPE from a third country on the Union market;

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Identical definitions can be found in most other EU regulations and directives which mandate CE marking.

That said, a company can technically import products and also be defined as a manufacturer.

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‘manufacturer’ means any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark;

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As such, companies that are importing products based on their own design and branding are generally deemed to be manufacturers rather than “merely” importers. This is the case even if you have no production capacity at all and only utilise contract manufacturers in, for example, China.

Summary

✅ Importers include entities established in the EU

✅ Importers introduce products on the EU market from outside the EU (i.e., UK or China)

❌ Importers generally do not sell products with their brand

❌ Importers generally do not sell products based on their design

Case Study – Who is the importer?

Who designed the product?	Brand owner	Roles
Non-EU factory	Non-EU factory	Manufacturer: Factory Importer: EU importer
Non-EU factory	EU importer	Manufacturer: EU importer Importer: EU importer
EU importer	EU importer	Manufacturer: EU importer Importer: EU importer

In this guide, I focus on companies that are defined only as importers. CE marking requirements for manufacturers can be found in this guide.

What are the CE marking responsibilities for importers?

Whereas the manufacturer is responsible for “making” a product compliant with CE marking requirements, the importer is responsible for checking that the manufacturer has done their part.

In practice, this means that importers must:

✅ Understand which CE marking regulations and directives apply

✅ Obtain and review documentation, label files, and test reports

Below, I explain what a CE marking review process can look like from the importer’s perspective.

CE marking checklist for importers

Step 1: Research EU regulations and directives

The first step is to determine which EU regulations and directives apply to the product. Without this information, you cannot know what to ask for or if what you receive is correct.

For example, the DoC and test report must cover all applicable CE marking regulations and directives. Likewise, labelling requirements also depend on which specific regulations and directives apply.

Note that more than one CE marking regulation or directive can apply to the same product.

Example	Legislation	Required files (examples)
Sunglasses	PPE Regulation	1. PPE DoC 2. PPE label files 3. PPE instructions 4. PPE test report
Toy	Toy Safety Directive / Toy Safety Regulation	1. TSD/TSR DoC 2. TSD/TSR label files 3. TSD/TSR instructions 4. EN 71 test report 5. Digital Product Passport* *Future requirement
Power bank	EMC Directive RoHS Directive Battery Regulation	1. DoC: EMCD / RoHS / BR 2. Label files: EMCD / RoHS / BR 3. Instructions: EMCD / RoHS / BR 4. Battery QR code label 5. Battery safety test report 6. EMC and RoHS test reports

As you can see in the table above, the specific regulations and directives that apply to your product determine the information you need to obtain from the manufacturer.

Step 2: Request information

As you can see in the table above, the specific regulations and directives that apply to your product determine the information you need to obtain from the manufacturer.

If, for example, I were to verify the CE marking status of a plastic toy, I would need to request the following:

✅ Toy Safety Directive – Declaration of Conformity

✅ Toy Safety Directive – Technical Documentation

✅ EN 71-1, 2 and 3 test reports

✅ Toy instructions and warnings

✅ Toy label files – CE marking, manufacturer information, and Annex V symbols

As you can see, the information request must be highly specific.

Step 3: Check labels and documentation

Once you have received the files, you need to carry out a gap analysis and review if these are correct.

Example	Item	Received	Checklist
	DoC	Yes / No	1. Is the product name or model correct? 2. Is there a product image present? 3. Does the image show the correct product? 4. Is the manufacturer name matching? 5. Are all applicable EU regulations and directives listed? 6. Are all applicable standards listed? 7. Are the standards up to date?
	Technical Documentation	Yes / No	Compare the items to what is required in the Annex/es
	Labels	Yes / No	1. Is the product name or model correct? 2. Is a serial or batch number present? 3. Is the manufacturer name matching? 4. Is the manufacturer’s address and contact point present? 5. Is the CE mark present? 6. Is the CE mark of the correct proportions and size? 7. Are the required warnings, instructions, and safety information present? (if required) 8. Is the notified body number specified? (if required)
	Test report	Yes / No	1. Is the test report issued in the last year or two? 2. Has the manufacturer made changes since the last test? 3. Is the product name or model correct? 4. Is there a product image present? 5. Does the image show the correct product? 6. Is the manufacturer name matching? 7. Are all applicable standards included? 8. Are the standards up to date? 9. Are these the same standards as in the DoC? 10. Is the test report issued by a known testing company?
	Instructions	Yes / No	Compare the information to the relevant articles in applicable CE marking regulations and directives

You can find an in-depth guide explaining how to check CE marking files in this guide.

Step 4: Affix importer information

Most CE marking regulations and directives require that the following information is present:

• Importer name, registered trade name or registered trade mark
• Importer postal address at which they can be contacted

This information can be placed on the product, packaging, or accompanying documentation.

Note that the importer information must be provided in addition to the manufacturer information.

Step 5: Translations

CE marking regulations and directives also require that certain information is translated into the official or “commonly understood” languages of the EU member states where the product is sold.

This generally includes the following:

• Instructions
• Warnings
• Safety information

If you, for example, import products from a manufacturer in China, then the EU importer will almost certainly need to assist with translations. This is usually also the case when importing products from manufacturers in the United States and the United Kingdom.

FAQ

Are importers responsible for CE marking?

Yes, importers are responsible for CE marking in the sense that they must validate that the manufacturer has fulfilled their CE marking obligations. This is often done by requesting and validating documentation, label files, and test reports.

However, the manufacturer is ultimately responsible for “making” the product CE marking compliant, and affix the actual CE mark.

The role of the importer is best understood as an external auditor.

What kind of documents do I need from the manufacturer?

The specific documentation that must be requested from the manufacturer depends on the applicable regulations and directives. That said, the following is often required.

• Declaration of Conformity
• Technical documentation
• Label files
• Instructions
• Test reports
• EC-type examination certificate (in some cases)

Do importers need to obtain a Declaration of Conformity?

Yes, the importer is responsible for obtaining the Declaration of Conformity and validating that it contains the correct information.

It should also be supported by verifiable test reports.

Do importers need to obtain technical documentation?

Yes, the importer must request and obtain technical documentation. This is often easier said than done, as many companies consider this to be their intellectual property and may therefore refuse to share it.

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

If the supplier cannot provide the required documentation to demonstrate full compliance with CE marking regulations and directives, then you simply cannot fulfill your importer obligations.

This means that you would introduce products that are not compliant and therefore illegal to sell.

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

No, a CE mark alone does not make a product safe and compliant. CE marking must always be supported by documentation and labelling, and it’s your job as an importer to check this.

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 CE mark if similar products are already sold in the EU?

For many years I have been asked this question:

“Do we need to CE mark a product that is already sold in the EU?”

Oftentimes, it turns out that they are referring to products that “look” similar to what they intend to import. To be clear, CE marking is product- and manufacturer-specific. CE marking simply does not carry over from one product to a group of unrelated products.

Now, what if the product is in fact the exact same (design, components, materials, and functionality) and from the exact same manufacturer?

Can you still rely on the assumption that:

a. It is already sold in the EU

b. Therefore, it is likely CE marked

The answer is no; you cannot make this assumption, and it is not the way CE marking works.

For starters, it is difficult or even impossible to determine that you are buying “the same” product, even if it’s the same factory. Second, you do not know if the CE mark was correctly affixed. Plenty of EU importers don’t comply with their importer obligations.

Third, regulations and directives provide clear importer obligations which mandate that all importers must verify the CE marking status of products they introduce in the EU. There is no way around this or an exemption.

If you want to rely on existing CE marking validation, then you need to buy the product from a company established in the EU.

Why can’t I rely on my supplier to guarantee that the product is CE marked?

Various CE marking directives often state that the importer should ensure that the manufacturer’s 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, 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.

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 labelled.

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.

Key Points

• Manufacturers are responsible for CE marking
• They are also responsible for testing, labelling, and documentation
• Manufacturers can be located in the EU and outside
• Manufacturers must share information with importers

Continue reading Guide to CE Marking Responsibilities for Manufacturers