Guide to CE Marking Responsibilities for Manufacturers

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

Who is defined as a manufacturer?

The first step of the process is to determine if you are defined as a manufacturer or not. This definition can be found in the EMC Directive:

‘manufacturer’ means any natural or legal person who manufactures apparatus or has apparatus designed or manufactured, and markets that apparatus under his name or trade mark;

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

In any case, the definition makes it clear that:

a. Companies that manufacture products can be defined as manufacturers

b. Companies who design and/or brand products made by external companies can also be considered as manufacturers

Example A: Factory

A factory in Poland designs and manufactures PPE that they sell to various distributors in the EU. The Polish company is the manufacturer both in practical terms and as defined under most CE marking regulations and directives.

Example B: Brand owner

A Spanish company designs toys that they then order from a factory in China. The Spanish company is defined as the manufacturer as it is their design and brand.

IF they had imported, for example, Mattel toys for resale, then they would have been an importer rather than a manufacturer.

What are the CE marking responsibilities for manufacturers?

The manufacturer is essentially responsible for ensuring that the product meets the requirements set by all applicable CE marking regulations and directives. This can involve the following:

1. Identify applicable regulations/directives

2. Identify applicable harmonised standards

3. Ensure that the product is designed to meet the relevant standards and other requirements

4. Create documentation

5. Affix labels

6. Arrange testing

7. Obtain certification from a notified body (if applicable)

In short, the manufacturer must manage the entire compliance process from start to finish.

CE marking process for manufacturers

The process breaks down many of the key steps a manufacturer must complete to CE mark a product.

Step 1: Identify regulations/directives

CE marking on a product indicates that the product is compliant with all applicable CE marking regulations and directives. Note that many products are subject to more than one.

Overview

• Toy Safety Directive
• Toy Safety Regulation
• RoHS Directive
• EMC Directive
• Low Voltage Directive
• Ecodesign Directive
• Radio Equipment Directive (RED)
• Battery Regulation
• EU Cybersecurity Act
• Machinery Regulation
• PPE Regulation
• Medical Devices Regulation

Which specific regulations and directives a product is subject to depends on the scope and whether your product fits the description.

Example: Bluetooth speaker

The following may apply to a Bluetooth speaker:

Regulation/Directive	Area
RoHS Directive	Heavy metals
EMC Directive	EMC requirements
Low Voltage Directive	Electrical safety
Radio Equipment Directive (RED)	Radio equipment requirements
Battery Regulation	Battery safety and performance
EU Cybersecurity Act	Cybersecurity

Note that each regulation and directive covers a specific area.

Assessment

Once identified, we often follow this checklist to map out the requirements:

✅ Identify and read the article titled “Obligations of manufacturers”

✅ Determine which conformity assessment procedure applies to your product

✅ Determine if that conformity assessment procedure requires a notified body

Step 2: Identify harmonised standards

CE marking regulations and directives tend to set general requirements. That said, technical requirements for specific product types can often only be found in harmonised standards.

Your job as a manufacturer is to:

✅ Identify applicable harmonised standards

✅ Implement the requirements into your product

Example: EN 71-1

EN 71-1 sets mechanical requirements for toys, and is harmonised under the Toy Safety Directive. As such, compliance with the Toy Safety Directive can only be achieved if a toy is compliant with EN 71-1 and other applicable harmonised standards.

This, in turn, requires that a toy meets the specific technical requirements set by EN 71-1. Here are some areas covered:

• Small parts
• Sharp points
• Battery compartments

As such, a manufacturer must understand the technical requirements and make adjustments to their design files and ensure that prototypes are made that are inherently compliant by design.

Step 3: Testing and certification

Now that you have a “designed for compliance” prototype, you can proceed to testing. Many CE marking regulations and directives do not explicitly state that the manufacturer must arrange third-party testing.

In practice, however, this is necessary as long as the manufacturer does not have in-house expertise and equipment to carry out testing according to applicable harmonised standards. Unless you are Apple or Mattel, you probably don’t have the capability.

As such, contacting a lab to arrange testing is generally what you must do to verify compliance with applicable standards.

Examples

Here are some examples of companies that can help manufacturers with testing:

• QIMA
• Intertek
• SGS
• TUV Rheinland
• Bureau Veritas
• Eurofins
• STC Group

Test Report

Once completed, the manufacturer receives a test report, which will later be included in the technical documentation.

EC-type examination certificate

Some products can only be sold if first examined and sometimes tested by a notified body. This is generally determined by the applicable conformity assessment procedure.

Step 4: Affix labelling

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The CE mark must generally be affixed to the product, or the packaging or instructions when it’s not possible to affix it directly on the product. The following labelling requirements may also apply:

✅ Product type, batch or serial number or other element allowing its identification

✅ Manufacturer name, registered trade name or registered trade mark

✅ Manufacturer postal address and contact point

✅ Warnings, instructions, and pictograms

✅ Notified body number (if applicable)

Note that some harmonised standards also contain labelling requirements.

Step 5: Create documentation

Next, it’s time to prepare documentation. The table below lists key documents required for manufacturers when CE marking products.

Example	Title
	Declaration of Conformity The DoC generally contains the following information: Product model Image Manufacturer details List of harmonised standards List of EU regulations and directives Notified body details (if applicable) Name and signature
	Technical documentation The technical documentation generally contains the following: Product model Product description Manufacturer details Technical drawings Descriptions Label files Packaging files Applied harmonised standards Test reports

Instructions

Many CE marking regulations and directives also require that the manufacturer creates instructions that accompany the product. The information requirements also tend to be quite specific.

For example, the following must be included for electronic products covered by the EMC Directive:

• Assembly
• Installation
• Maintenance
• Usage
• Restriction of use (if any)

Now, bear in mind that instructions cannot be of such a nature that it goes against the principles set by the relevant CE marking regulations and directives.

You cannot, for example, provide instructions that state that sunglasses should not be worn outside or that toys should not be used by children. This also applies to warning labelling.

FAQ

Can manufacturers issue CE certificates?

No, manufacturers cannot issue a “CE certificate”. However, manufacturers must issue a Declaration of Conformity that is based on testing which verifies compliance with applicable harmonised standards.

Can importers be classified as manufacturers?

Yes, if an EU company imports products based on their design or brand, then they are likely defined as the manufacturer. This means that importers can assume the full set of obligations that apply to manufacturers for CE-marked products

Yes, even if it’s just one guy with a laptop.

Can non-EU manufacturers CE mark products?

Yes, non-EU companies can and often do CE mark products. There is no requirement that the manufacturer must be located inside the European Union.

That said, non-EU manufacturers are subject to the same obligations as those based in the EU.

Are non-EU manufacturers selling B2C responsible for CE marking?

Yes, non-EU manufacturers are responsible for ensuring compliance with CE marking regulations and directives when selling directly to consumers.

Note that non-EU manufacturers selling CE-marked products to consumers in the EU generally also need an EU authorised representative.

Are non-EU manufacturers selling B2B responsible for CE marking?

It depends. If you are a non-EU manufacturer selling your own products (your design and/or brand) to an importer in the EU, then you are still defined as the manufacturer and therefore responsible for making the product compliant.

But if you are, for example, a contract manufacturer in Shenzhen making products for other companies, then your customers are likely defined as manufacturers, as it’s their design and brand.

This is also why it’s so important to first determine which company is the manufacturer. This is not something that can be decided later in the process.

What kind of documents do manufacturers need to provide to EU importers?

Importers are responsible for verifying that products are CE marked, tested, correctly labelled, and documented. Here are some of the files you should share with an EU importer asking for compliance documentation:

1. Declaration of Conformity (DoC)

2. User instructions

3. Technical file

4. Lab test reports

5. Label photocopies

Who will check if the manufacturer has correctly CE-marked a product?

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”.

Authorised representative missing

The customs authorities have the right to remove parcels shipped directly to consumers in the EU, in case the packaging lacks EU authorised representative information.