The "standard items" and "product scope" of EU CE certification—standards serve as risk-scenario-tailored technical baselines, while product scope defines compliance boundaries dynamically adjusted with new regulations. In 2026, the EU’s dual transformation focus on "digitalization" and "sustainability" has integrated new regulations such as cybersecurity, carbon footprint, and Digital Product Passports (DPP) into the certification system. Mismatched standards or overlooked policy adjustments will result in either test failure or cargo detention.
As a creator tracking cross-border compliance for 6 years, I combine the latest EN standard list effective January 2026, revised New Battery Regulation (EU 2023/1542), New Construction Products Regulation (EU 2024/3110), and frontline test cases to break down "three-dimensional classification of standard items (basic + new regulations + scenarios) + product risk grading (low/medium-high/special) + pitfall avoidance guidelines." All information corresponds to the EU Official Journal or practical cases, helping you accurately determine "which standards apply to which products" and avoid 90% of compliance pitfalls.
1.Standards are not "one-size-fits-all lists" but "technical correspondences to risk scenarios"
Not all electronic products only require EMC + LVD testing. For example, smart home appliances with Wi-Fi have been mandatory to add RED Directive radio frequency standards (EN 300 328) and cybersecurity standards (EN 18031 series) since August 1, 2025—missing any item will be rejected by NBs. A smart home manufacturer in early 2026 failed to test the anti-fraud requirements of EN 18031-3, resulting in a 2-week delay and lost orders due to re-testing.
2.Product scope is not a "fixed category" but a "dynamic boundary covered by new regulations"
In 2026, building products added the "Digital Product Passport (DPP)" standard. Small decoration accessories (e.g., special adhesives) that previously did not require CE certification now need to comply with the CPR Regulation’s EN 13813 bond strength standard if used in public buildings. Some low-risk medical devices covered by old directives can continue using old standards until 2028 under the transition Regulation (EU 2023/607) but require advance application for a certificate.
3."Multi-directive coverage" is not "simple superposition" but "standard priority adaptation"
For example, automotive USB-C chargers must comply with LVD (EN 61558), EMC (EN 55032), and the New Battery Regulation’s charging safety standard (EN 62133-2). In terms of priority, they must first meet the EMC anti-interference requirements for automotive scenarios (30% stricter than ordinary home appliances) before testing other items—incorrect order will lead to repeated rectifications.
II. 2026 CE Certification Standard Items
The core of CE standard items is "first meet general basics, then adapt to new regulations and scenarios." In 2026, the key additions focus on "cybersecurity, carbon footprint, and digital compliance." Standards across different dimensions have clear regulatory support and cannot be confused:
(I) General Basic Standards: "Baseline Requirements" for All Products (Corresponding to EU General Directives)
These form the foundation of compliance with no major changes in 2026, but test precision requirements have increased, mainly covering three core standard categories:
1. Electrical Safety (LVD Directive 2014/35/EU)
-Application scenario: All electrical products with rated voltages of 50V-1000V AC / 75V-1500V DC (home appliances, adapters, power tools).
-Core standards:
·Home appliances: EN 60335-1 (2025 revised version, adding standby power consumption ≤0.3W requirement).
·Audio-visual equipment: EN 62368-1 (replacing old EN 60950, emphasizing overheating protection for battery charging).
-2026 detail: Testing must simulate "extreme voltage fluctuations" (±10% rated voltage). An adapter manufacturer was deemed non-compliant during EU customs inspection for failing this test.
2. Electromagnetic Compatibility (EMC Directive 2014/30/EU)
-Application scenario: All electronic and electrical products (from mobile phone chargers to industrial machine tools).
-Core standards:
·Consumer products: EN 55032 (radiation limit ≤40dBμV/m), EN 55035 (anti-interference ≥20dBμV).
·Industrial equipment: EN 61000-6-2 (anti-interference requirements 10dBμV higher than consumer products).
-Pitfall avoidance: Wireless products require additional testing for "coexistence of radio frequency and EMC." For example, Bluetooth-enabled table lamps must ensure Bluetooth operation does not interfere with light control signals.
3. Restriction of Hazardous Substances (RoHS Directive 2011/65/EU)
·Application scenario: Electronic and electrical products (complete machines and components).
·Core standard: IEC 62321-10 (2025 revised version, adding TBBPA testing with a limit of ≤0.1%).
·2026 addition: Adjustments to the exemption list—lead solder joints previously exempted can be used in medical devices until 2027, while ordinary home appliances must complete replacements by the end of 2026.
(II) 2026 New Regulation Specific Standards: Mandatory "Compliance Additions" (Corresponding to the Latest Regulations)
These are the "key increments" of 2026 certification—non-compliance means failure to meet requirements, mainly focusing on three areas:
1. Cybersecurity Standards (RED Directive Supplementary Regulation EU 2022/30)
-Application scenario: Wireless products with network connectivity (Wi-Fi, Bluetooth, 5G devices such as smartwatches and routers).
-Core standards: The EU Official Journal listed the EN 18031 series as harmonized standards in January 2025, with mandatory implementation starting August 1, 2025, including three parts:
·EN 18031-1:2024 (corresponding to RED Article 3(3)(d), preventing network damage and service degradation, requiring mandatory default password changes).
·EN 18031-2:2024 (corresponding to RED Article 3(3)(e), protecting personal data and user privacy, requiring AES-256 encryption support).
·EN 18031-3:2024 (corresponding to RED Article 3(3)(f), preventing fraud risks, requiring identity authentication mechanisms).
2. Carbon Footprint and Due Diligence Standards (Revised New Battery Regulation EU 2023/1542)
-Application scenario: All battery products (portable batteries, energy storage batteries, electric vehicle batteries).
-Core standards and timelines:
·Carbon footprint declaration: Electric vehicle batteries must be completed by February 18, 2025; industrial batteries by February 18, 2026, calculated in accordance with ISO 14067.
·Carbon emission requirements: Energy storage batteries must ≤100kg CO₂eq/kWh (EN 16258 standard).
·Due diligence obligations: Originally scheduled to take effect on August 18, 2025, revised by the European Commission in July 2025 to August 18, 2027. However, enterprises must establish supply chain traceability systems in advance.
-Key reminder: The extension does not mean reduced standards—core requirements such as carbon footprint calculation and Battery Passports still proceed as planned.
3. Digital Product Passport (DPP) Standards (New CPR Regulation EU 2024/3110)
·Application scenario: Building products (doors/windows, fireproof materials, load-bearing components).
·Core standards: EN 17457 (DPP data format, including production batch, environmental indicators, and installation/maintenance cycles), EN 13501-1 (fire rating—public building materials require Class A2).
·Key requirement: DPP data must be synchronously uploaded to the EU CPIS platform; otherwise, the CE certificate is invalid.
(III) Scenario-Specific Standards: "Tailored Requirements" for High-Risk/Special Products
These standards correspond to specific risk scenarios. In 2026, the focus is on "medical, explosion-proof, and automotive" scenarios, with standards far exceeding general requirements:
1. Medical Device-Specific Standards (MDR 2017/745)
-Application scenario: From Class I surgical instruments to Class III implantable devices.
-Core standards:
·Biocompatibility: EN ISO 10993-1 (cytotoxicity testing; implantable devices require additional sensitization testing).
·Clinical data: EN ISO 14155 (clinical research norms; Class III devices require 5-year follow-up data).
-Transition policy: Class II devices certified under the old MDD directive can continue using it until 2028 under (EU 2023/607) but require annual compliance declarations every 2 years.
2. Explosion-Proof Scenario Standards (ATEX Directive 2014/34/EU)
·Application scenario: Equipment for explosive environments (e.g., chemical plant sensors, mining machinery).
·Core standards: EN 60079-0 (general explosion-proof requirements), EN 60079-1 (flameproof enclosures, shell pressure resistance ≥1.5MPa).
·Test detail: Must simulate "dust + gas mixed explosion environments." A sensor manufacturer failed to test the dust scenario, resulting in a 3-week delay for re-testing.
3. Automotive Scenario Supplementary Standards (RED Directive Automotive Appendix)
·Application scenario: In-vehicle wireless devices (e.g., car infotainment systems, Bluetooth microphones).
·Core standards: EN 301 489-19 (in-vehicle radio frequency anti-interference, resisting engine electromagnetic radiation), EN 62368-3 (in-vehicle electrical safety, temperature range -40℃~85℃).
·Difference from ordinary products: Anti-interference requirements are 20% higher than household devices. A car infotainment manufacturer repeatedly failed tests using household Wi-Fi modules and only passed after switching to automotive-specific modules.
III. 2026 CE Certification Product Scope
The core of product scope is "first determine risk level, then match directives and standards." In 2026, new product compliance boundaries mainly cover "digital building products, high-risk batteries, and connected medical devices." Low-risk products also require attention to detail adjustments:
(I) Low-Risk Products: Self-Declaration Allowed, 2026 Focus on "Detail Compliance"
These products do not require NB involvement but must meet standard details, mainly including three categories:
1. Ordinary Electronic/Electrical Products (Home Appliances, Lamps, Non-Connected Adapters)
·Applicable directives: LVD + EMC + RoHS.
·2026 detail: Lamps require additional "photobiological safety" testing (EN 62471, blue light hazard Class ≤ RG0). A table lamp manufacturer had its goods recalled in Germany due to excessive blue light.
·Pitfall avoidance: Do not use "engineering prototypes" for testing—submit mass-produced versions. An adapter manufacturer passed testing with engineering samples but was deemed non-compliant during mass production due to component quality reductions.
2. Children’s Toys (For ages under 14, e.g., building blocks, plush toys)
·Applicable directive: Toy Safety Directive (2009/48/EC).
·Core standards: EN 71-1 (physical safety, small part pull force ≥90N), EN 71-3 (chemical substances, phthalates ≤0.1%).
3. Simple Building Materials (Household tiles, ordinary wallpaper)
·Applicable directive: CPR Regulation.
·Core standard: EN 14411 (tile slip resistance—≥ R10 for bathroom use).
·New regulation linkage: If used in public areas of apartment buildings, simplified DPP data (manufacturer, environmental indicators) must be provided starting in 2026.
(II) Medium-High Risk Products: NB Involvement Mandatory, 2026 Focus on "New Regulation Alignment"
These products require NB review. In 2026, the core focuses on "cybersecurity, carbon footprint, and clinical data," mainly including four categories:
1. Wireless/Connected Products (Routers, Smart Home Appliances, 5G Modules)
·Applicable directives: RED + LVD + EMC + Cybersecurity Supplementary Regulation.
·2026 key requirement: Submit a "security update plan" (required by EN 18031, at least one firmware update per year). A smart speaker manufacturer had its NB review rejected for failing to provide this plan.
·Standard priority: Test radio frequency (RED) first, then cybersecurity (full EN 18031 series), and finally EMC to avoid repeated rectifications.
2. Medical Devices (Class I and above, e.g., blood glucose meters, surgical scissors)
·Applicable directives: MDR/IVDR.
·2026 key requirement: Class III devices must upload clinical data to the EUDAMED database. A dialysis equipment manufacturer experienced a 2-month certificate delay due to incomplete data.
·Transition adaptation: Products with old MDD certificates must apply for extension certificates (EU 2023/607) by Q3 2026 to avoid order disruptions.
3. Battery Products (Energy Storage Batteries, Electric Vehicle Batteries)
·Applicable directives: New Battery Regulation (EU 2023/1542) + LVD + EMC.
·2026 key requirement: Energy storage batteries must complete carbon footprint declarations per requirements (EN 16258). A manufacturer’s declaration was rejected for using an old calculation standard that excluded raw material extraction data, requiring 3 weeks for re-calculation.
·Future preparation: Before the due diligence obligation takes effect on August 18, 2027, proactively obtain full-chain data from suppliers and establish a Battery Passport data framework.
4. Machinery Products (Industrial Machine Tools, Injection Molding Machines)
·Applicable directive: Machinery Directive (2006/42/EC).
·Core standards: EN ISO 12100 (risk assessment, emergency stop response ≤0.5 seconds), EN 60204-1 (electrical safety, grounding resistance ≤0.1Ω).
·2026 addition: Connected machinery requires additional cybersecurity testing (EN 18031 series). A machine tool manufacturer failed to comply, preventing integration into EU factory IoT platforms.
(III) Special Scenario Products: Additional Industry Standards Required, 2026 Focus on "Digital Compliance"
These products must meet both CE and industry-specific requirements. In 2026, the "Digital Product Passport" is newly added, mainly including two categories:
1. Building Products (For Public Buildings) (Fire Doors, Load-Bearing Steel Beams)
-Applicable directive: New CPR Regulation (EU 2024/3110).
-Core requirements:
·Safety standards: EN 13501-1 (fire doors require EI 60 class, fire resistance for 60 minutes).
·Digital standards: EN 17457 (DPP data must include "installation/maintenance cycles" and be synchronized to the CPIS platform).
-Case: A fire door manufacturer for office buildings had its project acceptance rejected for failing to upload DPP data.
2. Explosion-Proof Equipment (Chemical Sensors, Mining Motors)
·Applicable directive: ATEX Directive.
·Core standards: EN 60079-29-1 (gas environment testing), EN 60079-31 (dust environment testing).
·2026 detail: Product labels must indicate "explosion-proof class + applicable environment" (e.g., Ex d IIB T3 Ga). A manufacturer’s incorrect labeling resulted in cargo detention at Belgian customs.
IV. 2026-2028 Compliance Trend Outlook: Key Areas for Advance Layout
1.AI regulation implementation: The EU Artificial Intelligence Act took effect in August 2024. High-risk AI systems must complete compliance by August 2026, and General Purpose AI (GPAI) systems will be subject to basic rules starting August 2025. Although CE certification-specific standards are still under development, products with AI functions should establish risk management systems in advance.
2.Continuous tightening of battery regulations: After the due diligence obligation takes effect on August 18, 2027, battery enterprises must achieve full-chain traceability from raw material extraction to recycling. Starting in 2028, lead content limits (≤100ppm) will apply to portable zinc-air button batteries—advance planning for alternative materials is required.
3.Expansion of digital compliance scope: Beyond Building Product DPP, industrial equipment and medical devices may gradually be included in the Digital Product Passport system starting in 2027. Advance reservation of data storage and upload interfaces is necessary.
CE certification standards and products are no longer based on a simple "checklist" logic. The key in 2026 is to "first identify the product’s risk scenario, then match the corresponding basic standards + new regulation requirements." For example, while household power banks only require LVD + EMC testing, energy storage batteries need additional carbon footprint + explosion-proof testing.
BLUEASIA Technology: +86 13534225140 provides professional certification consulting services.
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