1. Overview of CE Certification

CE certification is a mandatory compliance mark established by the European Union (EU) for product safety, health, and environmental protection. It indicates that a product meets the essential requirements of relevant EU directives and harmonized standards. As a "passport" for accessing the European Economic Area (EEA) and EU markets, CE certification is not a single certification system but a collection of over 20 directives covering various product categories, applicable to machinery, electronics, medical devices, wireless equipment, and more.

In 2025, the EU further strengthened the technical adaptability and sustainability requirements of CE certification, focusing on updating directive provisions in fields such as machinery, medical care, and wireless equipment, emphasizing digital traceability, cybersecurity, and circular economy design concepts. It should be noted that CE certification is only mandatory for products within the scope of the directives; non-electrical daily necessities (such as furniture and clothing) do not require certification.

2. Introduction to CE Marking

The CE mark is a visual identifier that a product complies with EU compliance requirements. Its use must strictly follow the EU CE Marking Regulation (Regulation (EU) 2019/1020), with key specifications including:

Marking Location: Priority should be given to affixing it on a prominent position of the product itself. If limited by product size, it can be marked on the packaging or user manual to ensure clarity.
Size Requirements: The minimum height shall not be less than 5mm, and the proportion must be maintained; when enlarging or reducing, the original graphic proportion shall be preserved.
Additional Information: If the product requires intervention by a Notified Body for certification (such as high-risk medical devices), the body's identification number (formatted as "NB XXXX", where XXXX is a four-digit code) must be marked next to the CE mark.
Usage Specifications: Altering the mark style is prohibited, and similar marks that may mislead consumers shall not be used. Unauthorized affixing of the mark without compliance certification will face legal liability.

3. Significance of CE Certification for Enterprises

CE certification is not only a legal requirement for market access but also a strategic tool for enterprises to enhance competitiveness

Market Access Guarantee: Obtaining CE certification is a prerequisite for products to legally enter the EU and EEA markets, avoiding risks of sales bans, customs detention, or fines due to non-compliance.
Consumer Trust Building: The CE mark represents that the product has passed strict safety and quality assessments, helping to enhance European consumers' recognition and purchase intention of the brand.
Breaking International Trade Barriers: As a unified EU compliance standard, CE certification replaces the original separate national certifications, significantly reducing the repeated testing costs for enterprises to enter multiple European markets.
Driving Technological Upgrading: The 2025 new regulations require enterprises to integrate advanced technologies such as digital tracking and cybersecurity into product design, forcing enterprises to improve R&D capabilities and product competitiveness.

4. CE Certification Process (2025 New Version)

Identify Applicable Directives and Standards: Query the directives corresponding to the product through the EU "Nando Database" (e.g., LVD + EMC directives for electrical and electronic products, RED directive for wireless equipment), and confirm the latest harmonized standards (such as EN 60335-1:2024).
Risk Assessment and Compliance Path Selection: Identify potential risks of the product in design, production, and use (such as electric shock, mechanical injury). Low-risk products can adopt self-declaration (Module A), while high-risk products (such as pressure vessels, Class III medical devices) need to select the Notified Body intervention mode (Module B/C/D).
Technical Documentation Preparation: Compile technical files including product manuals (multilingual versions), design drawings, key component lists (CE-marked components must be selected), risk assessment reports, test reports, etc., ensuring the completeness and standardization of the documents.
Laboratory Testing and Certification Application: Entrust EU-accredited laboratories (such as TÜV, SGS) to conduct targeted tests (electrical safety, EMC, radio frequency performance, etc.). After passing the tests, submit the application and technical documents to the selected Notified Body.
Audit and Certificate Issuance: The Notified Body conducts document review and, if necessary, conducts on-site factory inspections. After passing the audit, the CE certificate is issued (usually valid for 5 years). For self-declaration products, a Declaration of Conformity (DoC) must be signed and archived.
Continuous Compliance and Market Supervision: Ensure the consistency between mass production and certified samples, retain test records for at least 10 years, pay attention to standard updates regularly (such as EN 62368-1 replacing the old audio-visual equipment standard), and respond to EU market spot checks.

5. Relevant Standards and Directives (2025 Key Updates)

Product Category	Applicable Directive	Key Harmonized Standards	2025 Update Highlights
Low-voltage Electrical Equipment	LVD Directive (2014/35/EU)	EN 60950-1, EN 60335-1	Strengthened energy efficiency labeling requirements, added standby power consumption limits
Electrical and Electronic Equipment	EMC Directive (2014/30/EU)	EN 61000-6-3, EN 61000-6-4	Expanded immunity test requirements for 5G equipment
Wireless Communication Equipment	RED Directive (2014/53/EU)	EN 300 328, EN 301 893	Added cybersecurity assessment (EN 303 645) and battery thermal runaway protection standards
Medical Devices	MDR Regulation (2017/745)	EN ISO 13485, EN 60601-1	Stricter clinical data requirements, AI medical software requires separate compliance assessment
Machinery	Machinery Directive (2006/42/EC)	EN ISO 12100, EN 60204-1	High-risk machinery must implement UDI digital tracking system

6. Notes

Risk of Directive Misjudgment: Avoid missing judgments for products covered by multiple directives (such as smart speakers needing to comply with LVD, EMC, and RED directives simultaneously). It is recommended to confirm the scope of application through the EU EUDAMED database or consulting professional institutions.
Supply Chain Compliance Management: Require key component suppliers to provide CE certificates and test reports to avoid整机 certification failure due to non-compliant components. It is recommended to include supplier compliance in contract terms.
Timeliness of Technical Documentation: Technical documents must be updated in a timely manner after design changes and compliance must be re-evaluated. Documents must be in EU official languages (English, German, etc.) to avoid translation errors.
Notified Body Selection: Priority should be given to Notified Bodies whose qualification scope covers the product category to avoid invalid certificates due to insufficient institutional authority. The institution's qualification can be verified through the Nando Database.
Response to Market Supervision: After receiving a non-compliance notice from EU regulatory authorities, rectification materials must be submitted within 15 working days, and product retesting must be conducted regularly (at least once a year) to ensure continuous compliance.

7. Common Resources and Tools

EU Nando Database: Query Notified Body qualifications (Official Link)
EUDAMED Database: Exclusive platform for medical device CE certification (Official Link)
Harmonized Standards List: EU official EN standard update catalog (Example Link)
Authoritative Certification Bodies: EU-accredited Notified Body networks such as TÜV Rheinland, SGS, Intertek, and UL