Combining the latest 2026 policies (e.g., mandatory EUDAMED implementation, new battery regulation details, MDR/IVDR revision proposal), as well as 2026 pricing systems from authoritative institutions and real payment cases from cross-border enterprises, this article breaks down "cost structure logic + product-specific latest quotes + new regulatory surcharges + money-saving tips" — helping you calculate both "explicit and implicit costs" to achieve compliance on a budget.

I. Three Core Insights on 2026 CE Certification Costs

1."Price is not fixed — it’s a dynamic cost package" — CE certification cost = basic testing fee + new regulatory surcharge + institution service fee + implicit costs. 2026 adds EUDAMED registration fees (for medical devices) and carbon footprint verification fees (for battery products). The same product that cost 5,000 yuan in 2025 may cost 8,000 yuan in 2026.

2."What’s the difference in institution quotes? Not service — but qualifications and new regulatory adaptation capabilities" — Institutions offering EUDAMED registration guidance and carbon footprint verification charge 10%-20% higher prices than ordinary institutions, but avoid subsequent supplementary testing, ultimately saving money.

3."Implicit costs are the biggest expense" — Rectification fees for test failures (50%-80% of basic testing fees), market launch delays due to EUDAMED registration hold-ups, and fines for fake certificates are often 10 times higher than certification fees. A medical enterprise lost 2 million yuan due to invalid certificates from a low-cost institution.

II. 2026 CE Certification Cost Structure

CE certification costs extend beyond the "institution quote sheet" — include all related expenses. The 2026 core changes lie in "new regulatory surcharges" and "digital service fees":

(I) Explicit Costs: Four Mandatory Expense Categories (2026 Latest Standards)

1. Basic Testing Fees (Core Expense)

Calculated based on product directives and test items — the main component of quotes. 2026 test items have increased due to new regulations:

·Electrical/Electronic Products: EMC + LVD basic testing fees: 1,800-4,000 yuan (approximately $258-$570); wireless products add RED Directive testing (5G devices require additional DFS dynamic frequency selection): 2,000-5,000 yuan (approximately $285-$715) extra.

·Battery Products: Under new battery regulation requirements, thermal abuse testing and carbon footprint verification are prioritized — basic testing fees are 30% higher than 2025. Portable batteries: 3,000-6,000 yuan (approximately $430-$860); energy storage batteries: 15,000-30,000 yuan (approximately $2,145-$4,290).

·Medical Devices: Class I self-declaration products: 3,000-8,000 yuan (approximately $430-$1,150); Class IIa devices require NB review: 20,000-80,000 yuan (approximately $2,875-$11,500); Class III devices require clinical data: 100,000-500,000 yuan (approximately $14,375-$71,875).

2. New Regulatory Surcharges (2026 Additions/Increases)

·EUDAMED Registration Service Fees: Exclusive to medical devices, including SRN application, UDI filing, and certificate upload guidance. NBs charge 5,000-15,000 yuan (approximately $715-$2,145); third-party consulting institutions: 3,000-8,000 yuan (approximately $430-$1,150) (NBs are recommended to avoid information inconsistencies).

·Carbon Footprint Verification Fees: Required for batteries, home appliances, and building materials. Portable batteries: 2,000-5,000 yuan (approximately $285-$715); energy storage batteries and home appliances: 10,000-30,000 yuan (approximately $1,430-$4,290).

·UKCA Transition Adaptation Fees: For products covering both EU and UK markets, differential testing for dual certification costs 60%-80% of CE certification fees. During the grace period, this can be reduced to 40%-50% through "shared test data".

3. Institution Service Fees (Charged by NBs/Laboratories)

·Non-NB Institutions: Only provide test reports — service fees account for 20%-30% of basic testing fees, suitable for low-risk self-declaration products.

·Notified Bodies (NBs): Mandatory for high-risk products. Service fees include review and on-site audits (e.g., hazardous machinery, Class III medical devices), accounting for 30%-60% of total costs. NB service fees for Class IIa medical devices: 10,000-50,000 yuan (approximately $1,430-$7,185); for Class III: 100,000-300,000 yuan (approximately $14,375-$43,125).

4. Auxiliary Fees

·EU Authorized Representative (EC REP) Annual Fee: Increased to 2,000-10,000 yuan/year (approximately $285-$1,430/year) (by product category) in 2026 due to EUDAMED information synchronization requirements. Select an EC REP capable of updating EUDAMED information.

·Technical Document Preparation Fees: Outsourcing required if no in-house expertise. Ordinary products: 500-2,000 yuan (approximately $71-$285); medical devices (complex documents including clinical data and risk assessments): 3,000-15,000 yuan (approximately $430-$2,145).

(II) Implicit Costs: Three Easily Overlooked Expense Categories

1.Rectification and Re-Testing Fees: Costs for adjustments after test failures. 2026 sees a 20% increase in rectification rates due to additional test items. Electrical/electronic products: 1,000-3,000 yuan (approximately $145-$430); medical devices: 50,000-200,000 yuan (approximately $7,185-$28,750) (e.g., supplementary clinical data).

2.Time Costs: Market launch losses due to delayed testing cycles. Ordinary electronic products: 7–10 working days; wireless products: 15–25 working days; medical devices: up to 18 months. A home appliance enterprise lost 3 million yuan in orders due to missing the Christmas peak season.

3.Non-Compliance Costs: Fines for fake certificates or incomplete documents. EU fines reach up to 4% of annual sales. An energy storage enterprise was fined 150,000 euros for counterfeit carbon footprint reports.

III. 2026 Latest EU CE Conformity Certification Cost References

Costs vary significantly by product category, directive requirements, and new regulatory impacts. Below are industry practice averages (including explicit and estimated implicit costs) for direct reference:

1. Low-Risk Products (Ordinary Toys, Non-Connected Small Appliances, Stationery)

·Total Cost: 2,000-7,000 yuan (approximately $285-$1,015). Basic testing fees: 1,800-4,000 yuan (approximately $258-$570); technical document preparation fees: 500-1,500 yuan (approximately $71-$215); no new regulatory surcharges (toys require additional chemical testing: 500-1,000 yuan/$71-$145).

·Money-Saving Tips: Choose ILAC-accredited domestic laboratories; self-declaration avoids NB fees; conduct internal pre-testing to prevent rectification.

2. Medium-Risk Products (Wireless Earbuds, Ordinary Machinery, LED Lamps, Portable Batteries)

·Total Cost: 5,000-30,000 yuan (approximately $715-$4,300). Basic testing fees: 3,000-15,000 yuan (approximately $430-$2,145); new regulatory surcharges (battery carbon footprint): 2,000-5,000 yuan (approximately $285-$715); NB service fees (machinery products): 1,000-5,000 yuan (approximately $145-$715).

·Money-Saving Tips: "Batch certification" for wireless and machinery products (multiple models in a series) reduces testing fees by 20%-30%; battery enterprises organize supply chain data in advance to minimize carbon footprint verification iterations.

3. High-Risk Products (Medical Devices, Energy Storage Systems, Hazardous Machinery)

·Medical Devices (Class IIa): Total Cost: 30,000-120,000 yuan (approximately $4,300-$17,100). Basic testing fees: 20,000-80,000 yuan (approximately $2,875-$11,500); EUDAMED registration service fees: 5,000-15,000 yuan (approximately $715-$2,145); EC REP annual fee: 5,000-10,000 yuan (approximately $715-$1,430).

·Energy Storage Systems: Total Cost: 80,000-350,000 yuan (approximately $11,500-$50,300). Basic testing fees: 15,000-30,000 yuan (approximately $2,145-$4,290); carbon footprint verification fees: 10,000-30,000 yuan (approximately $1,430-$4,290); NB service fees: 30,000-100,000 yuan (approximately $4,300-$14,375); estimated rectification fees: 20,000-80,000 yuan (approximately $2,875-$11,500).

·Money-Saving Tips: For medical devices, leverage the MDR revision proposal’s "representative product sampling" to reduce series product testing fees by 35%; for energy storage systems, select institutions offering "one-stop services" (testing + carbon footprint + NB review) to avoid duplicate charges from multiple institutions.

IV. 2026 Money-Saving Tips: Four Practical Compliance Strategies (Based on New Regulations)

1.Leverage Regulatory Dividends to Reduce Test Items — After the MDR/IVDR revision proposal takes effect (expected 2026 or later), select one representative product for full testing among series Class IIa/IIb medical devices; other variants only require difference statements, reducing certification costs by 30%-40%. Battery products meet carbon footprint requirements in advance to avoid subsequent supplementary testing.

2.Prioritize Pre-Testing to Avoid Rectification Waste — Conduct pre-testing with laboratories before formal testing (costs 30%-50% of formal testing fees, e.g., 1,000-2,000 yuan/$145-$285 for electrical/electronic products). This identifies 80% of issues. A lamp enterprise passed formal testing on the first attempt after pre-testing rectification, saving 2,500 yuan in rectification fees.

3.Choose "One-Stop Service" Institutions to Avoid Duplicate Charges — For medical devices, select NBs offering integrated services (testing + EUDAMED registration + EC REP + EUDAMED upload) to reduce total costs by 10%-15%. For battery products, choose institutions providing simultaneous carbon footprint verification and CE testing to avoid data inconsistencies across multiple institutions.

4.Rationalize UKCA Transition and Share Test Data — For products covering both EU and UK markets, share CE test data during the grace period, only conducting UKCA differential testing — costs are 50% lower than separate certification. Reserve space for UKCA marking on product bodies before January 2026 to avoid secondary mold modification costs.

CE certification costs are not "the cheaper the better" but "every dollar spent on compliance". 2026 new regulatory surcharges (EUDAMED, carbon footprint) are mandatory, and implicit costs pose the greatest risk. Enterprises should:

1.Clarify product categories and target markets in advance, precisely matching directives to avoid unnecessary testing.

2.Select the right institution, prioritize pre-testing, and reduce costs by leveraging regulatory dividends.

3.Retain complete technical documentation, track regulatory updates in a timely manner, and avoid non-compliance fines.

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