Drugdu.com expert's response:

CE certification is a mandatory safety certification for products entering the EU market. Its process aims to ensure that products comply with the basic requirements of the EU's New Approach to Technical Harmonization and Standardization directives, covering aspects such as safety, health, environmental protection, and consumer protection. Below is a detailed overview of the CE certification process and key points:

I. Core Process Steps

Determine Applicable Directives and Standards

Directive Identification: Based on the product type (e.g., electrical equipment, machinery, medical devices), identify the applicable EU directives, such as:

Low Voltage Directive (LVD): Applies to electrical equipment with rated voltages between 50V and 1000V.

Electromagnetic Compatibility Directive (EMC): Ensures devices do not interfere with other equipment and are immune to interference.

Machinery Directive (MD): Covers all machinery products, including safety components.

Standard References: Many directives have corresponding European harmonized standards (EN standards), such as EN 60335 (safety of household appliances) and EN 55032 (EMC for multimedia equipment). Compliance with these standards simplifies the certification process.

Product Risk Assessment

Hazard Identification: Analyze potential risks during product design, manufacturing, and use (e.g., electrical fires, mechanical injuries, chemical exposure).

Mitigation Measures: Develop risk reduction strategies, such as adding protective devices, optimizing material selection, or providing warning labels.

Select Compliance Assessment Path

Self-Declaration: Suitable for low-risk products (e.g., ordinary electronic devices, toys). Manufacturers can conduct their own testing and sign a Declaration of Conformity (DoC).

Third-Party Certification: High-risk products (e.g., medical devices, pressure equipment, elevators) require testing or auditing by an EU Notified Body, which issues a CE certificate.

Product Testing and Documentation Preparation

Testing Content:

Safety Testing: Insulation resistance, voltage withstand testing, fire resistance.

EMC Testing: Radiated emissions, immunity to interference.

Chemical Testing: RoHS 2.0 (restriction of hazardous substances), REACH (chemical registration).

Specialized Testing: Biocompatibility testing for medical devices, small-part testing for toys.

Technical Documentation:

Design Files: Drawings, circuit diagrams, material lists.

Test Reports: Compliance test results issued by laboratories.

Risk Analysis: Potential risks and mitigation measures.

User Manuals: Instructions for use, safety warnings, maintenance guidelines.

Declaration of Conformity (DoC): A statement declaring compliance with all applicable directives, including manufacturer information, product model, signing date, and responsible person's signature.

Affix the CE Mark

Mark Requirements: The CE mark must be at least 5mm in height, with a fixed proportion, and clearly and permanently affixed to the product, packaging, or user manual.

Notified Body Number: If third-party certification is used, the CE mark must include the Notified Body's identification number (e.g., "CE 0123").

Market Surveillance and Compliance Maintenance

Document Retention: Technical files must be retained for at least 10 years for inspection by market surveillance authorities.

Design Change Management: If significant changes occur in product materials, structure, or functionality, compliance must be re-evaluated.

Market Inspections: EU member states may conduct random inspections of CE-marked products. Non-compliant products may face fines, recalls, or market bans.

II. Process Differences and Key Considerations

Directive and Standard Variations: Different product types must comply with distinct directives and standards. For example, medical devices must adhere to the MDR regulation, while ordinary electronic devices only require LVD and EMC compliance.

Certification Path Selection: Low-risk products can undergo self-testing, while high-risk products must be certified by a Notified Body. Companies should select the appropriate path based on product risk levels.

Document Language Requirements: Technical files must be prepared in an official EU language (e.g., English, French, German) to ensure review by regulatory authorities.

Mark Usage Guidelines: The CE mark must not be confused with other certification marks and must comply with size and placement requirements.

III. Certification Timeline and Costs

Timeline: Low-risk products take approximately 1–2 weeks (self-declaration), while high-risk products require 2–6 months (involving a Notified Body).

Costs: Depend on product type, testing complexity, and whether a Notified Body is involved. For example, medical device certification costs may exceed those for ordinary electronic devices.

IV. Corporate Responsibilities and Compliance Commitments

Legal Liability: Manufacturers are fully responsible for product compliance. The signed Declaration of Conformity holds legal weight.

Ongoing Compliance: Products must remain compliant throughout their lifecycle, including re-evaluation after design changes.

Market Access: The CE mark is a "passport" for products entering the European Economic Area. Products without the mark may be detained or destroyed.