We have consolidated core information regarding the documents required for EU CE-RED certification and its validity period as of October 2025, specifically including the mandatory cybersecurity new regulations effective from August 2025. The table below summarizes the core documents needed.
Document Category Core Content & Explanation Special Reminders
Product Technical Documentation User Manual (English/Relevant Languages): Must include CE mark, declaration of conformity, safety warnings, wireless operation instructions.
Circuit Diagrams & Block Diagrams: e.g., PCB layout, Bill of Materials (BOM).
Wireless Technical Specification File: Detailed description of operating frequencies, transmit power, modulation methods, etc. Technical documentation is a key focus of review; ensure accuracy.
Testing-related Samples & Documents Test Samples:Typically need 1 regular sample + 1 RF fixed-frequency sample (capable of continuous transmission/reception).
Complete Test Reports: Covering RF, EMC, Electrical Safety (LVD), etc. Fixed-frequency samples require corresponding software
Compliance & Administrative Documents Declaration of Conformity (DoC): Signed by the manufacturer declaring product compliance with RED directive.
Certification Application Form: Accurately filled with product and manufacturer info.
Product Label & Label Design Drawing: Must reserve space for CE mark; information must be clear and permanent.
Non-EU manufacturers must provide EU Authorized Representative (EAR) info.
Key Reminders on 2025 Cybersecurity New Regulations:
Starting August 1, 2025, all devices with wireless functions must meet new cybersecurity requirements, otherwise they cannot enter the EU market. This new regulation is based on the EN 18031 series standards. Pay special attention to:
1.Core Requirements: The new regulations primarily include three core requirements: equipment must **not harm networks or their resources, must protect user personal data and privacy, and possess fraud prevention capabilities.
2.New Test Items: Certification testing now includes added items like Penetration Testing (simulating hacker attacks) and Firmware Security Audits (vulnerability code scanning).
3.Specifics for Different Products:
·General Devices (e.g., routers): Need to disable default passwords, have secure update mechanisms.
·Children's or Wearable Devices: May require mandatory AES-256 encryption and location data protection.
·Payment Terminals: Require transaction data verification and physical tamper-resistant design.
CE-RED Certification Process and Certificate Validity Period:
Understanding the complete process helps plan time and resources:
1.Preparation: Identify standards applicable to the product and prepare technical files accordingly.
2.Laboratory Testing: Send samples to a lab for testing. Standard items include EMC, RF performance, LVD, and the newly added cybersecurity tests. Failed tests requiring rectification can prolong the cycle.
3.Certification Review & Issuance: After passing tests, the lab or Notified Body reviews and issues the certificate upon approval.
Certification Cycle and Validity Period:
·Certification Cycle: Under normal circumstances, the entire process takes 4-8 weeks. With expedited service, it can be shortened to 2-3 weeks, but costs increase by 30%-50%.
·Certificate Validity Period: This is a crucial point. The CE-RED certificate itself has no fixed validity period. However, its validity is conditional. The certificate may become invalid, requiring re-assessment or a new application, under the following circumstances:
·When EU standards are updated (approximately every 5 years).
·After the product undergoes design changes or hardware modifications.
·Failure to adapt to mandatory regulatory upgrades**, e.g., if the product only complies with old standards but not the mandatory cybersecurity new rules effective August 2025.
·Technical File Retention Period: Manufacturers must retain complete technical documentation and the DoC for at least 10 years, for potential inspection by EU market surveillance authorities.
Practical Advice and Risk Mitigation:
·Optimization Strategy: During the product design phase, prioritize using wireless modules already certified for CE-RED. This can significantly simplify the final product certification process and complexity.
·Avoid Risks: Ensure the product nameplate permanently bears the CE mark with a height not less than 5 mm. Non-certified or non-compliant products face risks of sales bans, customs detention/destruction, and high fines (up to 4% of annual global turnover).
We hope this detailed document list and process explanation helps you efficiently complete CE-RED certification. If you can specify your type of wireless product (e.g., Bluetooth speaker, smartwatch, industrial router), BLUEASIA Tech: 13632500972 will provide professional certification consulting services!
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