CE RED Directive Certification Steps & Timeline

2026-01-13

Most online articles still frame CE RED certification as a simplistic "test-and-certify" process. In reality, since the mandatory enforcement of cybersecurity regulations in August 2025, the entire compliance workflow has evolved into a systematic project centered on "technical documentation" as core evidence, spanning the entire product lifecycle.

This article breaks down the core steps and the logic behind dynamic timelines, aligned with the latest regulatory requirements.

The Three-Stage Framework for CE RED Directive Certification

Traditional "sample testing" is just one piece of the puzzle. Full RED compliance follows a three-stage framework, whose core output is a complete set of technical documentation—not just a certificate.

1.Compliance Strategy Planning & Technical Documentation Development (Timeline: 2–4 weeks, most variable)This is the most critical phase, determining the direction and efficiency of all subsequent work. Key focus areas include:

·Product Classification & Standard Mapping: Precisely classify the product under the RED device categories and identify all applicable Harmonized Standards. For example, a smart speaker supporting Wi-Fi 6 and Bluetooth must comply with RF, EMC, and safety standards, as well as the mandatory EN 18031 series of cybersecurity standards.

·Gap Analysis & Risk Assessment: Conduct pre-assessments against applicable standards, with a specific focus on identifying design flaws related to cybersecurity and personal data protection. This step can greatly reduce the risk of subsequent testing failures.

·Initiate Technical Construction File (TCF) Compilation: The TCF is the legal and technical cornerstone of certification. It must include product descriptions, design drawings, a list of applicable standards, risk assessment reports, test reports, and a Declaration of Conformity. Since 2025, technical documentation must also contain detailed evidence of cybersecurity assessments.

2.Testing, Evaluation & Declaration of Conformity (Timeline: 4–8 weeks, depends on product and certification pathway)This phase involves verifying product compliance through execution:

·Test Execution: Conduct testing at a qualified laboratory. In addition to conventional RF, EMC, and safety tests, cybersecurity assessments are now a key focus. For complex or high-risk products (e.g., medical devices), review and oversight by an EU Notified Body are mandatory.

·Finalize Technical Documentation & Declaration of Conformity: Integrate all test reports and evidence to form the final TCF. The manufacturer or their authorized EU Representative signs the EU Declaration of Conformity, which serves as the product’s legal "identity document" for the EU market.

3.CE Marking & Post-Certification Maintenance (Ongoing)

·Apply CE Marking: Affix the CE mark to the product in accordance with regulatory requirements.

·Post-Market Surveillance & Document Updates: Manufacturers must monitor products on the market and report any accidents or serious risks. If product designs change, standards are updated (e.g., revised harmonized standards), or new regulatory requirements take effect, manufacturers must re-evaluate and update the technical documentation accordingly. For example, updates to the EN 18031 cybersecurity standards may trigger re-evaluation of already certified products.

  There Is No "Standard Timeline" for CE RED Certification

Total certification time ranges from 6 weeks to over 20 weeks, primarily influenced by five variables:

1.Product Complexity & Risk Level: The testing scope and depth for a Bluetooth headset are vastly different from those for a smartwatch with 5G and payment functions.

2.Depth of Cybersecurity Compliance: This is the biggest new variable post-2025. A product’s connectivity capabilities and data processing methods determine the complexity of the cybersecurity assessment, potentially adding several weeks to the timeline.

3.Completeness of Technical Documentation (the most core variable): If a company provides clear, comprehensive technical data in the first phase, it will significantly reduce the time required for testing and certification body review. Conversely, disorganized documentation leads to repeated communication and delays.

4.Choice of Certification Pathway: Whether mandatory Notified Body involvement is required. Projects involving NBs will have longer timelines due to queueing for reviews and certificate issuance.

5.Number of Testing & Rectification Cycles: A higher first-time pass rate in testing shortens the timeline. Each design modification and retest cycle can add an additional 2–4 weeks.


Current CE RED certification steps are a process of building a "traceable compliance evidence system". The certification timeline is essentially a measure of a company’s efficiency in "technical compliance management". We hope this analysis, based on the latest practices and future trends, provides you with solid, differentiated content for your writing. For professional certification consulting services, contact BLUEASIA at +86 13534225140.