Drugdu.com expert's response:

The EU CE certification is primarily classified into three types based on certification modes (COC, AOC, DOC) and multiple types based on product directives, while the certification path also involves different module combinations. Here is a detailed classification and explanation:

I. Three Types Based on Certification Modes

COC (Certificate of Compliance)

Issuing Authority: Third-party organizations (e.g., intermediaries or testing and certification bodies).

Content: Typically accompanied by technical documentation (TCF) such as test reports, and enterprises are also required to sign a Declaration of Conformity.

Applicable Scenarios: Applicable to a variety of situations, whether for AOC or other products requiring certification under specific modes (e.g., B+D, B+E, H, etc.), a COC certificate may ultimately be obtained.

AOC (EC Attestation of Conformity)

Issuing Authority: EU Notified Bodies (NB).

Content: According to EU regulations, only NB organizations are qualified to issue such certificates.

Applicable Scenarios: Typically arises when product certification does not mandate NB involvement, but the applicant voluntarily requests NB participation to assist in reviewing technical documentation. Some organizations may issue an AOC certificate in such cases, while others may issue a COC certificate.

DOC (Declaration of Conformity)

Nature: A self-issued declaration of conformity by enterprises, without the need for third-party involvement.

Content: The DOC is a necessary document in CE certification, typically used for customs clearance and to demonstrate compliance with EU regulations.

Applicable Scenarios: Applicable to all products requiring CE certification, regardless of whether NB involvement is mandatory or not.

II. Multiple Types Based on Product Directives

Based on product characteristics and EU directive requirements, CE certification can also be classified into the following main types:

LVD (Low Voltage Directive) CE Certificate

Applicable Products: Electrical products with voltages between 50 and 1000 volts, such as household appliances and power tools.

Purpose: To ensure electrical safety of products and prevent hazards such as electric shock and fire.

EMC (Electromagnetic Compatibility) Directive CE Certificate

Applicable Products: Electronic devices, communication equipment, and information technology equipment, etc.

Purpose: To ensure that products meet requirements regarding electromagnetic radiation and interference resistance, protecting the environment and human health.

MD (Machinery Directive) CE Certificate

Applicable Products: Mechanical equipment, components, and safety protection devices, such as machine tools, elevators, and cranes.

Purpose: To ensure that products comply with safety standards during design, manufacturing, and use, reducing the risk of mechanical injuries.

Toy Directive CE Certificate

Applicable Products: Toy products sold on the market.

Purpose: To ensure that toys meet safety, hygiene, and environmental requirements, preventing injuries to children during use, such as suffocation or cuts.

PED (Pressure Equipment Directive) CE Certificate

Applicable Products: Equipment such as boilers, pressure vessels, and pressure pipelines.

Purpose: To ensure that products adhere to stringent safety standards during design and manufacturing, preventing hazards such as explosions or leaks.

PPE (Personal Protective Equipment Directive) CE Certificate

Applicable Products: Personal protective equipment such as safety helmets, protective goggles, and gloves.

Purpose: To ensure that equipment can effectively protect users from injuries.

R&TTE (Radio and Telecommunications Terminal Equipment Directive) CE Certificate

Applicable Products: Devices such as mobile phones and radio transmitters.

Purpose: To ensure that equipment meets electromagnetic compatibility requirements, ensuring smooth radio communications.

III. Module Combinations Based on Certification Paths

EU CE certification also involves different certification modules (Module), which define who is responsible for testing and the depth and scope of testing. Common module combinations include:

B+C Module: First, an NB organization tests a sample (B), and then the enterprise ensures that subsequent mass-produced goods are identical to the sample (C). This combination is common for products such as toys and medical devices.

B+F Module: After the NB evaluates a sample (B), it randomly inspects a portion of the finished products (F). This combination is used for some medium- to high-risk products.

D or E Module: If an enterprise has a robust production system (e.g., ISO 9001 certification), the NB may only review the enterprise's system (D or E).