CE Compliance Consulting | CE Certification Consultants

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Update time : 2026-01-14

In the European market, CE certification is undoubtedly the most crucial requirement among all market access standards. Without CE certification, products in numerous categories cannot enter the sales channels of the European Union (EU) and the European Economic Area (EEA).

The core of CE certification lies in ensuring safety: it focuses on whether a product poses a threat to humans, animals, and goods, rather than regULating the general quality of the product. Relevant directives mainly set basic safety standards, and specific technical details are usually supplemented by supporting standards.

CE Compliance Consulting | CE Certification Consultants(图1)

Therefore, it is important to clarify that: the ce marking is essentially a safety conformity mark, not a quality certification mark. As a mandatory pass for accessing the EU and EEA covering more than 30 countries, this marking indicates that the product has passed the inspection of the most basic safety requirements.

Key Notes on CE Certification

CE certification is essentially a set of directives, which includes more than 20 EU directives and regulations. For a specific product, all applicable directives must be complied with.

Directive/Regulation Code	English Full Name	Main Applicable Products
LVD	low voltage directive	Electrical equipment with AC voltage ranging from 50V to 1000V or DC voltage ranging from 75V to 1500V (e.g., small household appliances, power supplies, lighting fixtures, etc.)
EMC	Electromagnetic Compatibility Directive	All electronic and electrical products that may generate electromagnetic interference or be affected by it (including digital products and industrial equipment)
RoHS	Restriction of Hazardous Substances	All electronic and electrical equipment (restricting 10 types of substances such as lead, cadmium, mercury, etc.)
ErP/ECODesign	Energy-related Products Directive	Energy-related products (e.g., household appliances, lighting products, etc., requiring energy efficiency labels)
PED	Pressure Equipment Directive	High-pressure vessels, boilers, etc.
MDR/IVDR	Medical Devices Regulation	Medical devices (classified into Class Ⅰ, Ⅱa, Ⅱb, Ⅲ)
PPE	Personal Protective Equipment Regulation	Safety helmets, goggles, protective clothing, etc.

According to EU regulations, the legal entity responsible for the ce compliance of a product is the EU manufacturer or importer (a mandatory designation for non-EU enterprises), who assumes full responsibility for this compliance. Their core obligations include:

1. Conducting a complete conformity assessment procedure (usually including product testing and document review).

2. Drafting and formally signing the Declaration of Conformity (DoC).

3. Establishing and retaining technical documentation for at least 10 years from the date the product is placed on the market.

4. Ensuring that the product is correctly affixed with the CE marking.

Three Key Understandings of CE Certification

1. "Self-declaration" does not mean exemption from testing

For ordinary low-risk products (e.g., regular small household appliances), although manufacturers are allowed to confirm compliance with CE requirements through the "self-declaration" method, they must still conduct strict testing in accordance with EU harmonized standards and retain all test reports and technical evidence in full.

For high-risk products (e.g., medical devices, gas appliances, etc.), certification must be carried out by a Notified Body designated by the EU, and a conformity certificate issued by the body must be obtained (example of certificate number: NB 0123).

2. Technical documentation is the cornerstone of compliance

Technical documentation is the core proof of ce conformity. It should include complete materials such as product design drawings, Bill of Materials (BOM), risk assessment reports, test reports, and a copy of the Declaration of Conformity (DoC). This documentation must be retained for at least 10 years after the product is launched on the market and be ready for inspection by EU market surveillance authorities at any time.

3. The use of the CE marking must be standardized

①　The minimum height of the marking shall not be less than 5 millimeters, and it shall be clear, durable, and not easy to remove.

②　The marking must be affixed to the product itself, its packaging, or accompanying documents (e.g., instruction manuals).

③　Unauthorized use of the CE marking on uncertified products is strictly prohibited.

Required Documents for Applying for CE Certification

To ensure the smooth progress of the CE compliance process, you need to prepare the following documents in advance:

1. Product technical drawings / BOM.

2. Declaration of Conformity (DoC) template.

3. eu authorized representative agreement.

4. Complete test reports (issued by ISO 17025-accredited laboratories).

Amazon Special Compliance Requirements

1. Certification Differentiation: UL (for the U.S. market) and CE (for the European market) are two independent certifications and must be applied for separately.

2. Document Upload: Submit the DoC and test reports in the "Compliance" section of the seller central.

3. Label Update: Products sold on the UK site must be affixed with the ukca marking.

4. Risk Control: Even with CE certification, products must continuously meet general safety requirements such as the General Product Safety Directive (GPSD).