CE certification processes are no longer "step-by-step" but "module-specific deadline tracking + product-specific adaptation + domestic-international policy alignment". A single misstep in timing can prevent product launches or miss peak seasons.

Combining the January 2026 mandatory EUDAMED registration update, phased carbon footprint requirements under the new battery regulation, the launch timeline for Building Product Digital Product Passports (DPP), and the latest practical processes from authoritative institutions and real cross-border enterprise cases, this article corrects previous timeline inaccuracies, adds guidance for new categories like building products, and breaks down "phase-specific precise steps + product-specific timelines + new regulatory alignment tips + pitfall avoidance guidance". All information is based on official announcements and on-the-ground practice to help you accurately manage every critical time window.

I. Four Core Insights on 2026 CE Certification Timelines

1.EUDAMED is Not "Launching in May" — Mandatory Registration Began in January — Starting January 2026, EUDAMED’s registration function is officially mandatory. All economic operators of medical devices (manufacturers, authorized representatives, etc.) must initiate Single Registration Number (SRN) applications. Other modules like UDI device registration are being implemented in phases. Enterprises failing to register in a timely manner will be unable to proceed with subsequent certification processes. A Jiangsu medical enterprise delayed registration until mid-January, resulting in a 3-week hold-up due to approval queues.

2.Carbon Footprint Verification is Not "Mandatory in 2026" — But "Data Preparation is Essential" — Mandatory carbon footprint requirements under the EU new battery regulation are being implemented in phases by product category. 2026 focuses on data collection for energy storage and industrial batteries. China also launched automotive power battery carbon footprint declaration at the end of 2025 — building carbon data management capabilities is a dual requirement of both domestic and international policies. An energy storage enterprise missed the domestic declaration window due to delayed data organization, impacting EU compliance progress.

3.Timelines Depend Heavily on "Product Complexity + Document Preparation + Institution Scheduling" — While basic timelines for low-risk products are short, incomplete documentation can double the time required. For high-risk products, the core delay is not testing but technical interactions with NBs and clinical evaluations. For Class III medical devices, clinical data review accounts for over 60% of the 12-18 month timeline.

4.Digital and Green Requirements are Cross-Category — EUDAMED is not exclusive to medical devices. Starting January 8, 2026, building products must synchronously upload Digital Product Passports (DPP). Digital document archiving has become mandatory for electrical/electronic and battery products — single-category compliance logic is no longer applicable.

II. 2026 CE Certification Full Steps + Timeline Breakdown

The core logic is "priority for pre-requisites + parallel steps + product-specific adaptation". Each phase adjusts operational priorities based on the latest new regulations to ensure accurate timeline planning:

(I) New Regulatory Preparatory Phase (0-8 Weeks — Core: "Meeting Deadlines + Data Preparation")

This is a critical prerequisite for 2026 certification. Enterprises must align with both EU new regulations and domestic policies, with targeted breakthroughs for different categories:

1. Product Positioning and Compliance List Compilation (1-2 Weeks)

·Operation: Clarify product category (including new building products), risk level, and target market. Match corresponding directives (e.g., EMC+LVD for electrical/electronic products, MDR for medical devices, new battery regulation for batteries, new CPR for building products). Mark "new regulatory exclusive requirements" (e.g., medical device SRN registration, building product DPP, battery carbon footprint data).

·Pitfalls: Building products must distinguish "whether covered by the new CPR". A building materials enterprise faced a 2-week delay due to ambiguous positioning and missing DPP preparation.

2. Documentation and Specialized Data Preparation (2-6 Weeks — Category-Specific Breakthroughs)

-Basic Documentation: Product drawings, BOM lists, mass-produced prototypes (3-5 units, avoiding engineering samples), manual drafts, and advance completion of internal pre-test reports (reducing subsequent rectification).

-New Regulatory Specializations (Core Time-Consuming Items):

·Medical Devices: Prepare enterprise qualifications, regulatory responsible person information, and EC REP SRN code. Immediately initiate EUDAMED SRN registration (4-8 weeks alone, can be done in parallel) — registration materials must be reviewed by the EC REP before submission to the competent authority.

·Battery Products: Organize full-chain data from "raw material extraction to production and transportation", obtain carbon footprint vouchers from suppliers, and synchronously complete basic materials for domestic power battery carbon footprint declaration (if applicable). Reserve 4-6 weeks for energy storage battery data collection.

·Building Products: Integrate technical documentation, EPD (Environmental Product Declaration) data, and supply chain information. Build a basic DPP data framework to adapt to upload requirements of the EU Construction Products Information System (CPIS).

·Dual-Market Products: Compile CE-UKCA differences and prepare test data sharing plans — the grace period allows reducing duplicate testing time.

3. Partner Selection (1-2 Weeks)

·Operation: Select an EC REP capable of synchronizing EUDAMED information (mandatory for medical devices). For institution selection, match new regulatory capabilities to categories — choose NBs providing SRN registration guidance for medical devices, institutions with carbon footprint verification qualifications for batteries, and laboratories familiar with DPP upload for building products.

·Timeline Reminder: 2026 NB scheduling is tight, especially for MDR reviews and building product DPP services — book 2-3 weeks in advance.

(II) Core Execution Phase (4-18 Months — Category-Specific Precise Timelines)

Due to phased mandatory new regulations, timelines vary significantly by category. The core is "aligning with module rhythms + controlling rectification time":

1. Test Application and Plan Confirmation (1-2 Weeks)

·Operation: Submit application materials, prototypes, and pre-test reports. Confirm test items (including new regulatory additions such as 5G device DFS testing, battery thermal abuse testing, and building product EPD verification). Specify "new regulatory service scope" in the service contract (e.g., SRN registration guidance, DPP upload assistance).

2. Test Execution and Rectification (3-12 Months — Category-Specific Details)

-Low-Risk Products (Ordinary Toys, Non-Connected Small Appliances): Basic testing takes 3-5 days, no new regulatory additions, low rectification rate (3-7 days total). Overall timeline: 7-14 days.

-Medium-Risk Products (Wireless Earbuds, Ordinary Machinery, Portable Batteries, Building Products):

·Wireless/Machinery Products: Wireless product testing (10-15 days, including RED+DFS); machinery product testing (7-10 days); rectification (1-2 weeks). Total timeline: 4-8 weeks.

·Portable Batteries: Testing (10-14 days, including thermal abuse); carbon footprint data verification (1-2 weeks); rectification (1 week). Total timeline: 4-7 weeks (no mandatory verification report submission in 2026 — focus on data validation).

·Building Products: Basic testing (7-10 days); DPP data integration and format adaptation (2-3 weeks); rectification (1-2 weeks). Total timeline: 6-12 weeks (synchronous CPIS platform upload required starting January 8, 2026).

·High-Risk Products (Medical Devices, Energy Storage Systems, Hazardous Machinery):

`Class IIa Medical Devices: Basic testing (4-8 weeks); EUDAMED SRN registration (4-8 weeks, parallel); rectification (2-4 weeks). Total timeline: 3-6 months (SRN approval varies by member state — reserve buffer time).

`Class III Medical Devices: Clinical data review (12-24 weeks); testing (8-12 weeks); EUDAMED full-module integration (6-8 weeks); rectification (4-8 weeks). Total timeline: 12-18 months.

`Energy Storage Systems: Testing (8-12 weeks); carbon footprint data verification (3-6 weeks, preparing for mandatory declaration in February 2026); NB review (2-4 weeks). Total timeline: 8-16 weeks.

`Hazardous Machinery: Testing (6-10 weeks); NB on-site audit (2-3 weeks, parallel to testing); rectification (2 weeks). Total timeline: 6-12 weeks.

3. Review and Certificate Issuance (1-4 Weeks)

·Low-Risk Products (Self-Declaration): After receiving the test report from the institution, sign the DoC within 1-2 days to complete compliance.

·Medium-High Risk Products: NBs review test reports and new regulatory specialized materials (SRN registration certificates, DPP data, carbon footprint materials). Medical devices require synchronous certificate upload to EUDAMED (7 working days); building products require CPIS platform data submission. Certificates are issued within 1-2 weeks of approval.

4. UKCA Transition Adaptation (Optional, 2-4 Weeks)

·Operation: Conduct differential testing using CE test data, sign the UKCA DoC. Starting 2026, ensure the mark is directly printed on product bodies (except for special cases). This can be done in parallel with CE review to save time.

(III) Compliance Maintenance Phase (Post-Certification to Product Discontinuation — Dynamic Tracking)

2026 compliance has no "endpoint" — continuous alignment with new regulatory updates and data maintenance is required:

1. Digital Archiving and Information Updates (1-2 Weeks + Ongoing)

·Operation: Digitally archive test reports, DoC statements, EUDAMED/SRN certificates, carbon footprint data, and DPP documents. Retain for 10 years for ordinary products, 15 years for medical devices. Update EUDAMED/CPIS platform information within 24 hours of changes; supplement DPP data throughout the product lifecycle.

2. New Regulatory Adaptation and Timeline Reservation (Timely Response)

·Medical Devices: Await mandatory notification for EUDAMED UDI device registration module — reserve 3-4 weeks for adaptation.

·Battery Products: Submit industrial battery carbon footprint declarations per new battery regulation requirements starting February 2026 — reserve 2 weeks for application.

·Building Products: Update DPP data to the CPIS platform quarterly and cooperate with regulatory inspections.

3. Long-Term Maintenance (Ongoing)

·Operation: Track MDR/CPR regulatory updates and conduct at least one self-audit of technical documentation alignment with new regulations annually. Medical device enterprises must cooperate with NBs for EUDAMED information review every 2 years to avoid certificate invalidation.

III. 2026 CE Certification Timeline Summary by Category

Combining the latest new regulations and practical cases, below are average timelines (including rectification, approval, and parallel operation optimizations) for direct product planning reference:

1.Low-Risk Products (Ordinary Toys, Non-Connected Small Appliances, Stationery): Total timeline 7-14 days — core time spent on testing and document archiving.

2.Medium-Risk Products:

·Wireless Earbuds/Ordinary Machinery: 4-8 weeks.

·Portable Batteries: 4-7 weeks (including carbon footprint data verification).

·Building Products: 6-12 weeks (including DPP data integration and CPIS upload).

3.High-Risk Products:

·Class IIa Medical Devices: 3-6 months (including 4-8 weeks for EUDAMED SRN registration).

·Class III Medical Devices: 12-18 months (including clinical review and full-module integration).

·Energy Storage Systems: 8-16 weeks (including carbon footprint verification preparation).

·Hazardous Machinery: 6-12 weeks (including NB on-site audit).

2026 CE certification timeline planning is no longer a "simple countdown" but requires aligning with phased mandatory EUDAMED rhythms, gradual carbon footprint milestones under the new battery regulation, and DPP launch requirements for building products — while linking domestic policies to achieve "dual EU-domestic compliance". Time is compliance dividend — 2026 EU new regulations are being rolled out intensively. Early completion of milestone alignment will seize market opportunities.

BLUEASIA Technology: +86 13534225140 provides professional certification consulting services.