Responsibilities of Importers and Manufacturers for Products Requiring CE Certification

Responsibilities of Importers and Manufacturers for Products Requiring CE Certification (2025 Guide)

For many products sold in the European Economic Area (EEA), the CE certificate and CE marking are mandatory. This obligation applies not only to manufacturers but also to importers and distributors. So, what responsibilities do manufacturers, importers, and distributors have for products requiring CE marking? Who is held responsible when an error occurs? Let’s clearly explain the roles of all parties according to the updated 2025 regulations.

⭐ Why Are Manufacturers and Importers Responsible?

The CE mark is a legal safety declaration demonstrating that a product:

Complies with EU directives
Has passed the required tests
Has a complete technical file
Is safely placed on the market

Therefore, in the CE process, who manufactures the product and who imports it is legally very important.

🟦 1. Manufacturer Responsibilities Under CE Certification

Before a product is placed on the EU market, the manufacturer must fulfill the following responsibilities:

1.1 Determining which EU legislation applies

The manufacturer must correctly determine whether the product falls under:

LVD
EMC
Machinery Directive
Toy Directive
MDR
RoHS / RED
or any other relevant EU regulation.

1.2 Performing required tests and preparing the technical documentation

The manufacturer is obligated to:

Conduct necessary testing at an accredited laboratory
Prepare a risk analysis
Prepare the technical documentation
Create a compliant user manual

This technical file must be kept for 10 years after the product is placed on the market.

1.3 Preparing the Declaration of Conformity (DoC)

The manufacturer must issue an EU Declaration of Conformity, formally declaring that the product complies with the applicable directives. Without a DoC, the CE mark cannot be used.

1.4 Affixing the CE mark correctly

The manufacturer must ensure that the CE mark is:

Properly sized
Clearly visible
Indelible

and placed on the product in accordance with regulation.

1.5 Ensuring continuous conformity in serial production

CE marking is valid once obtained, but if:

The product design changes
A component is replaced
Software is updated

then CE conformity must be re-evaluated.

🟧 2. Importer Responsibilities Under CE Certification

Anyone bringing a product into the EU/EEA from outside the EU is considered an importer. Therefore, importer responsibilities are just as serious as those of manufacturers.

2.1 Ensuring CE documentation is real and valid

The importer must verify that the product:

Bears the CE mark
Has a valid Declaration of Conformity
Has an existing technical file

Stating “the manufacturer said it’s CE compliant” is not sufficient.

2.2 Being responsible for product labeling information

The importer must place the following information on the product:

Company name
Contact details
Postal address

If this is missing, the product is considered non-compliant.

2.3 Conducting safety checks before placing the product on the market

The importer must ensure that:

Labeling is correct
The user manual is available in EU languages
The CE mark is properly affixed
The product is safe to use

If these checks are not performed, full responsibility falls on the importer.

2.4 Taking an active role in product recalls

If the product is found non-compliant, the importer must:

Initiate recall procedures
Inform consumers
Report to authorities

Importers are legally responsible for corrective actions.

🟥 3. Distributor Responsibilities

A distributor is not a manufacturer or importer. However, they are still responsible for ensuring the product they sell is safe. A distributor must:

Check the CE mark
Check labels and user manuals
Withdraw the product from the market if it is unsafe

⚠️ What Happens If These Responsibilities Are Not Fulfilled?

The following penalties may apply to both manufacturers and importers:

Market withdrawal
Product recall
Customs detention
Administrative fines
Destruction of products

Even the smallest error in the CE process can result in serious consequences.

🔵 How Sertifike Supports You

At SERTİFİKE, we assist manufacturers and importers by:

Clarifying their CE responsibilities
Planning required laboratory tests
Ensuring the CE mark is used legally and correctly

This ensures that all CE obligations are fulfilled accurately and completely.

CE Compliance Is a Shared Responsibility, and Mistakes Are Costly

Behind every CE-marked product stand:

The manufacturer
The importer
The distributor

Each carries a legal responsibility. Failure to fulfill these duties leads to serious legal and commercial consequences. A properly managed CE certification process is critical not only for product safety but also for brand reputation.

Sertifike