This guide is based on 2025 December EU latest regulatory practices (core basis: Delegated Regulation (EU) 2022/30 and Amendment (EU) 2023/2444/EU, standard version EN 18031-1:2023+A1:2024). Certification processes and timelines vary by product complexity and lab capacity—verify the latest regulations/standards via the Official Journal of the EU (OJEU) and ETSI website, or consult notified bodies for precise assessments before initiation.
Wireless device exporters to the EU care most about EN 18031-1 steps and timelines. Since 2025 mandatory enforcement, many enterprises faced delays: no pre-testing leading to 1-month rework; incomplete documents causing 3-week audit holds; underestimated factory audit time missing launch windows.
Critical premise: The 12-20 week process detailed here applies to products requiring notified body (NB) conformity assessment (e.g., complex industrial equipment, financial terminals, sensitive-function smart devices). Low-risk simple devices (e.g., basic Bluetooth speakers, standard wireless mice) qualify for the self-declaration (DoC) pathway (10-14 weeks, focusing on self-testing and document filing, no NB involvement). This guide focuses on the NB pathway, breaking down steps, timelines, and pitfalls.
EN 18031-1 General Cybersecurity Certification Process (12-20 Weeks)
1. Preliminary Assessment Phase (1-2 Weeks)
Easily overlooked but critical for efficiency—clarify product compliance requirements to avoid blind testing:
·Product compliance mapping: Confirm EN 18031-1 applicability (all wireless internet-connected devices: Wi-Fi, Bluetooth, cellular, etc.) and additional sub-standards (e.g., EN 18031-3 for payment devices, EN 18031-2 for children’s products). Reference EU Radio Equipment Committee (RRC) Product Classification Guidelines or request free NB pre-assessments for clear compliance boundaries.
·Standard gap analysis: For products with old EN 303645 certification, compare new EN 18031-1:2023+A1:2024 requirements (e.g., network resilience, update signatures) and list rectifications. A 2025 smart router manufacturer failed testing due to missing offline data encryption (no gap analysis), taking 3 weeks to rectify.
·Partner selection: Prioritize NBs/labs with cybersecurity expertise and sufficient capacity—they master 2025 latest processes and anticipate issues. Avoid small labs to prevent delays and low certificate recognition (risking customs holds later).
2. Design Rectification Phase (2-4 Weeks)
Skipping this phase leads to longer timelines—EN 18031-1 requires security-by-design, focusing on 3 core rectifications:
·Access control fixes: Remove all hardcoded defaults; enforce strong first-use passwords (≥8 chars, mixed case/numbers/symbols); tier permissions (admin/operator/guest) with firmware hard limits (e.g., operators cannot modify DNS). A smart camera manufacturer only hid permissions in interfaces (no firmware limits), causing 1-week rework.
·Secure update mechanism setup: Integrate firmware signature verification (RSA-2048/ECC-256); design A/B partitions/backup images to prevent bricking during updates. NBs strictly audited this in 2025—a smart bulb manufacturer lacked anti-rollback, taking 2 weeks to retest post-rectification.
·Network resilience optimization: Add DDoS protection to detect abnormal traffic; encrypt cached data with AES-256 to prevent offline leaks; auto-recover to retain critical data after crashes. Industrial devices need extra voltage fluctuation adaptability for unstable EU grids.
3. Pre-Testing Phase (2-3 Weeks)
Optional but adopted by most 2025 successful applicants—it pre-empts issues and avoids 80% re-test fees:
·Testing focus: Qualified third-party labs test 3 core modules (access control, secure updates, resilience) with detailed failure reports and rectification advice.
·Case example: An industrial sensor manufacturer found unencrypted offline cached data during pre-testing; lab-recommended secure chip storage enabled one-time formal testing pass, saving 3 weeks.
·Timeline note: 2-3 weeks standard; 1-week extension possible during peak seasons (Mar-May, Sep-Nov)—book 2 weeks in advance.
4. Formal Testing Phase (3-6 Weeks)
Initiate NB formal testing post-pre-test rectification—most timeline variation stems from 3 factors:
·Product complexity: Simple devices (basic Bluetooth speakers): 3-4 weeks; complex devices (multi-protocol industrial gateways, 5G terminals): 5-6 weeks (extra protocol compatibility and high-load security testing).
·Pass rate: One-time pass is fastest; each failed rectification adds 1-2 weeks. A 2025 smart lock manufacturer used TLS 1.1 (outdated), failing twice and delaying 3 weeks.
·Lab capacity: Peak seasons (Q2, Q4) have backlogs, extending timelines by 20-30%—avoid peaks or book 2-3 months early.
·Core tests: Penetration testing, firmware security audit, encryption validation, network resilience simulation—all must pass for audit eligibility.
5. Document Audit Phase (2-3 Weeks)
NBs conduct rigorous audits (no formalities in 2025) verifying document-product consistency—prepare complete documents upfront:
·Mandatory documents: Technical files (schematics with secure chips, BOM with certified critical components, firmware specs, security design); test documents (pre-test/final reports, rectification records); DoC draft (cite EN 18031-1:2023+A1:2024 & (EU) 2022/30, mark NB code).
·Common issue: Inconsistencies cause rejections (e.g., RSA-2048 in design docs vs. RSA-1024 in test reports delayed one manufacturer 1 week). Cross-check with tech and legal teams for accuracy.
·Timeline: 2 weeks for compliant docs; 1-week supplement required for gaps (delays otherwise).
6. Factory Audit Phase (1-2 Weeks)
Mandatory only for high-risk products (industrial control, financial terminals, medical wireless devices)—1-2 days on-site audit + 1-2 weeks report finalization:
·Audit focus: Production consistency (sustained alignment with test samples). Auditors check critical process controls (e.g., firmware encryption during programming), calibrated testing equipment, supplier certification records, and non-conformity handling.
·Warning case: A 2025 industrial gateway manufacturer failed due to expired equipment calibration, taking 2 weeks to re-audit post-rectification.
·Tip: Self-audit 1 month in advance to align processes with documents.
7. Conformity Assessment & Declaration Phase (1-2 Weeks)
Post all report approvals, NBs issue Conformity Assessment Reports—enterprises issue their own Declaration of Conformity (DoC), the core RED compliance document (mandatory details: product model, standards, NB code, date; no omissions allowed).
·Notes: DoC holders can be enterprises or EU authorized reps—ensure accuracy (e.g., matching product models) to avoid invalidation and customs issues.
·Next steps: Mark CE logo, NB code, and model on product nameplates/packaging per 2025 EU Marking Guidelines to prevent customs seizure.
EN 18031-1 Ongoing Maintenance Phase
DoCs have no fixed validity, but NBs conduct annual surveillance audits (easily overlooked), focusing on 2 key areas:
·Ongoing security updates: Shipments need ≥3 years of vulnerability patches.
·Vulnerability response: Dedicated teams monitor CVE databases and push fixes within 1 month of discovery.
·Warning case: A 2025 smartwatch manufacturer stopped updates 6 months post-launch, facing rectification orders and potential Conformity Assessment Report revocation (sales suspension risk).
·Tip: Establish a dedicated compliance team or outsource annual maintenance for sustained compliance.
2025 EN 18031-1 Timeline Overview & Action Tips
1. Timeline Summary
·NB pathway (12-20 weeks, ~3-5 months): Fastest 12-14 weeks (simple, pre-test pass, no factory audit); standard 15-17 weeks (medium, 1 minor rectification, no audit); slowest 18-20 weeks (complex, multiple rectifications, audit required).
·Self-declaration pathway (low-risk, 10-14 weeks): Core steps—preliminary assessment → design rectification → self/third-party testing → document filing → DoC issuance (no NB involvement, faster, lower cost).
2. Action Tips
-Advance planning: Integrate timelines into launch plans—reserve 4 months for NB pathway, 3 months for self-declaration; avoid peak seasons (Mar-May, Sep-Nov).
-Prioritize pre-testing: Don’t cut pre-test costs—one-time passes reduce rework; mandatory for complex devices.
-Early document preparation: Compile technical docs during design to avoid rushed, error-prone drafting later.
-Choose qualified partners: Prioritize cybersecurity-experienced NBs/labs for efficient communication and minimal delays.
EN 18031-1 timeline success hinges on thorough upfront preparation and pitfall avoidance. Solid design rectification, pre-testing, and documentation ensure on-time compliance. For pathway/timeline clarity based on your product model/functions, request precise NB assessments. For professional consulting, contact BLUEASIA at +86 13534225140.
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