When discussing CE certification materials and validity periods, materials must form a closed-loop evidence chain of "regulatory alignment + digital traceability," while validity periods represent a triple overlap of "certificate duration + transition policies + dynamic maintenance." EUDAMED information synchronization, Building Product Digital Product Passport (DPP) updates, and phased carbon footprint declarations—any deviation from official standards in any link will result in certification invalidation.
Combining the EU Medical Device Extension Regulation (EU) 2023/607, New Construction Products Regulation (EU) 2024/3110, New Battery Regulation (EU) 2023/1542, and RED Directive Cybersecurity Supplementary Regulation (EU) 2022/30, this article breaks down "compliance materials (basic + new regulations + transition) + validity period (certificate + policy + maintenance) + pitfall avoidance guidelines." All information corresponds to official legislative texts, ensuring every detail withstands verification.
1.The essence of materials: A "digitally traceable evidence chain aligned with regulations" — In 2026, materials must not only be complete but also correspond to specific regulatory provisions. For example, cybersecurity materials must comply with the RED Directive Supplementary Regulation (EU) 2022/30, and Building Product DPP must align with the New CPR Regulation (EU) 2024/3110. Simply compiling documents without meeting regulatory details will still result in rejection.
2.Validity period: An overlap of "certificate labeling + transition policies + dynamic compliance" — The "5-year" mark on Notified Body (NB)-issued certificates is not the sole basis. Medical device certificates under old directives can be extended via Regulation (EU) 2023/607, but enterprises must also fulfill obligations such as platform information updates and new regulation adaptation—both are indispensable.
3.Materials must cover three scenarios: Basic + New Regulations + Transition — High-risk products require not only current new regulation materials but also retention of old directive compliance credentials (e.g., MDD certificates and extension proofs). Dual-market products need supplementary materials for CE-UKCA differential adaptation.
4.New regulation materials have clear "scope of application" — Cybersecurity assessments only apply to connected wireless products; carbon footprint declarations are phased mandatory by battery category; Building Product DPP is currently limited to the scope of the New CPR. Blind preparation will unnecessarily increase compliance costs.
II. Mandatory 2026 CE Certification Materials
Material preparation focuses on "precise regulatory alignment + digital archiving + traceability." In 2026, it is crucial to supplement transition policy documents and new regulation detail materials, broken down by product category as follows:
(I) General Basic Materials for All Products (Corresponding to the EU General Compliance Framework—Indispensable)
1. Enterprise and Qualification Documents
·Business license/registration certificate (must be fully consistent with registration information on platforms such as EUDAMED and CPIS, with no discrepancies in company name or address).
·EU Authorized Representative (EC REP) qualification documents: Including the EC REP’s SRN code (mandatory for medical devices and building products) and service agreement, clearly defining the EC REP’s information update obligations (in line with MDR Art. 11).
·Quality Management System (QMS) certificate: Mandatory for high-risk products (e.g., ISO 13485 for medical devices, ISO 9001 for machinery products). The certificate must be valid and cover the corresponding product category.
2. Product Technical Documents (Digitally Archived, Supporting PDF/A-3 Format + Electronic Signature)
·Core technical data: Product drawings, PCB layouts, BOM lists (marking compliance numbers of core components, such as chip CE certification numbers and battery cell carbon footprint qualifications).
·Test reports: Issued by ILAC-accredited laboratories or NBs, covering all test items of the corresponding directives (e.g., EMC + LVD for electrical/electronic products, full EN 71 series for toys). Report numbers must be verifiable on the issuing institution’s official website.
·Declaration of Conformity (DoC): Attached with a QR code linking to test reports, NB information, and new regulation specific documents (SRN code, DPP number). Starting in 2026, it must be synchronously uploaded to the corresponding regulatory platform. The signatory must be the enterprise legal person or authorized compliance officer.
3. Sample-Related Materials
·3-5 mass-produced prototypes (consistent with technical document descriptions; no differences in core components from test samples).
·Prototype labels: Marked with the CE mark, product model, and EC REP contact information. High-risk products require additional exclusive identifiers (medical device UDI code, Building Product DPP QR code, battery carbon footprint grade indication).
(II) 2026 New Regulation Specific Materials (By Category + Regulatory Basis + Detail Requirements)
1. Medical Devices (MDR/IVDR + Transition Regulation (EU) 2023/607)
·EUDAMED-specific materials: Enterprise and EC REP’s Single Registration Number (SRN), UDI code and EUDAMED filing screenshot, certificate upload receipt (mandatory registration starting January 2026, full module launch on May 28).
·Clinical and safety materials: Class III devices require 5-year clinical follow-up data and computer simulation test reports (aligned with the MDR revision proposal direction). Connected devices need supplementary cybersecurity risk assessment reports (referencing EN 303 645 standard).
·Transition policy documents: Products certified under the old MDD/AIMDD directives require an extension certificate issued by the NB (high-risk medical devices extended to the end of 2027, medium-low risk to the end of 2028, in line with Regulation (EU) 2023/607).
2. Battery Products (New Battery Regulation (EU) 2023/1542)
·Carbon footprint-specific materials: Supply chain data ledger (full cycle from raw material extraction to transportation). Electric vehicle batteries must prepare mandatory carbon footprint declarations starting February 2025; industrial batteries need to complete basic data for phased implementation in 2027—both require verification by EU-recognized institutions.
·Safety and traceability materials: EN 62133-2 thermal abuse and overcharge protection test reports. Batteries with a capacity exceeding 2 kWh must establish a basic Battery Passport data framework (mandatory starting May 2026). The QR code design must link recycling information and carbon footprint data.
·China-EU linkage materials: Synchronously prepare domestic automotive power battery carbon footprint declaration materials (launched by the Ministry of Industry and Information Technology at the end of 2025, management system established by the end of 2026) to achieve multi-scenario reuse of data.
3. Building Products (New CPR Regulation (EU) 2024/3110)
·Building Product Digital Product Passport (DPP): Including full-life-cycle product data (design, production, installation, recycling), EPD (Environmental Product Declaration) report, and CPIS platform upload receipt. The format must comply with ISO 3166-2 standards to support cross-platform mutual recognition.
·Structural and compliance materials: Load-bearing building materials require structural performance test reports issued by NBs, raw material environmental compliance certificates, and production process quality control records. Data must be synchronized with DPP in real time.
4. Electrical/Electronic/Wireless Products (RED Directive + Cybersecurity Regulation (EU) 2022/30)
·Cybersecurity materials: Wireless products with network connectivity (Wi-Fi, Bluetooth, 5G, etc.) require risk assessment reports complying with the EN 18031 series (EN 18031-1 for cybersecurity mechanisms, EN 18031-2 for data privacy). These verify core requirements such as mandatory default password changes and security update mechanisms, with EN 303 645 as the basic adaptation basis.
·Specific test materials: 5G devices need supplementary DFS (Dynamic Frequency Selection) test reports; RoHS 3.0 compliance materials must include TBBPA (tetrabromobisphenol A) test certificates with a limit of ≤0.1%.
(III) Mandatory Digital Requirements for Materials (Corresponding to EU Multi-Category Regulatory Guidelines)
·Format and storage: All materials must be in PDF/A-3 format with electronic signatures by the enterprise legal person. Retain for 10 years for ordinary products and 15 years for medical devices. Building products must be synchronously stored on the CPIS platform to ensure EU regulatory authorities can access them online within 48 hours.
·Linkage and verification: The DoC QR code must enable "one-click access to all core materials." Information inconsistencies will be deemed "false declarations" under the EU Market Surveillance Regulation, with fines up to 4% of annual sales.
·Update obligations: Changes to material content (e.g., supplier replacement, technical parameter adjustments) must be updated in digital archives within 24 hours and synchronized to the corresponding regulatory platform (EUDAMED/CPIS).
III. In-Depth Interpretation of 2026 CE Certification Validity Period
The core of validity period is "sustained maintenance of compliance status," not a fixed expiration date. Combined with the latest regulations, the triple logic is broken down as follows:
(I) Triple Core Logic of Validity Period
1.Formal logic: Certificate-labeled duration — NB-issued certificates are usually labeled with 5 years (e.g., medical devices, hazardous machinery, building products). Low-risk self-declaration products have no explicit labeling but serve as "initial compliance documents."
2.Policy logic: Transition regulation extension — Under Regulation (EU) 2023/607, old MDD/AIMDD directive certificates can be extended: high-risk medical devices to the end of 2027, medium-low risk to the end of 2028. However, they must meet prerequisites such as "no major changes" and "continuous compliance with old directive requirements," and an extension certificate must be applied for from the NB in advance.
3.Substantive logic: Dynamic compliance obligations — Regardless of whether the certificate is expired or extended, three requirements must be met: ① Real-time platform information updates (complete EUDAMED/CPIS information changes within 24 hours); ② Timely adaptation to new regulations (e.g., phased battery carbon footprint declarations, cybersecurity standard upgrades); ③ Maintenance of product consistency (no major changes to core components or production processes; changes require advance notification and supplementary testing).
(II) Category-Specific Validity Period Maintenance Focus
1. Low-Risk Products (Ordinary Toys, Non-Connected Small Appliances)
·Maintenance focus: Complete retention of digital archives, functional DoC QR code verification, and no major product changes.
·Validity period: No fixed duration. Compliance remains valid as long as the above requirements are continuously met. Certification becomes invalid immediately if materials are lost or product changes are not reported. No transition policies apply.
2. Medium-Risk Products (Wireless Earbuds, Ordinary Machinery, Portable Batteries)
·Maintenance focus: Wireless products must follow updates to the EN 18031 series; machinery products require safety performance self-inspections every 2 years; portable batteries need annual carbon footprint data improvement (preparing for mandatory declarations in 2027).
·Validity period: 5 years as labeled on the certificate. Apply for renewal 3 months before expiration, requiring supplementary updated test reports and new regulation adaptation materials (e.g., cybersecurity upgrade testing, carbon footprint data updates).
3. High-Risk Products (Medical Devices, Energy Storage Systems, Hazardous Machinery, Building Products)
·Medical devices: 5-year certificate validity. Old directive certificates can be extended under Regulation (EU) 2023/607. NBs conduct EUDAMED information reviews every 2 years. Class III devices require continuous clinical data updates. Extended products must complete MDR conversion by the end of 2027/2028.
·Building products: 5-year certificate validity. Under the New CPR Regulation, DPP data must be updated to the CPIS platform quarterly, and EPD reports re-audited every 3 years—otherwise, the certificate is suspended.
·Energy storage systems/hazardous machinery: 5-year certificate validity. Energy storage systems need phased supplementary carbon footprint declarations under the New Battery Regulation; hazardous machinery requires annual safety self-inspection reports, with random factory audits by NBs.
(III) Six Key Trigger Conditions for Certification Invalidation
1.Failure to fulfill transition policy requirements: MDD/AIMDD extended products fail to apply for extension certificates on time or violate the "no major changes" prerequisite.
2.Delayed platform information updates: Invalid EUDAMED SRN registration or failure to update DPP data on the CPIS platform quarterly.
3.Overdue new regulation adaptation: Batteries fail to submit phased carbon footprint declarations; connected products fail to upgrade to the EN 18031 standard.
4.Unreported major product changes: E.g., replacement of battery cell suppliers or medical device chip models without supplementary testing and material updates.
5.Expired qualification documents: Termination of EC REP services or expired QMS certificates without timely replacement or renewal.
6.Unqualified market inspections: E.g., excessive chemical substances, cybersecurity vulnerabilities, or DPP data fraud—subject to penalties under corresponding regulations.
(IV) Three Key Actions for 2026 Validity Period Maintenance
1.Establish a 3D ledger of "regulations - timeline - materials": Record certificate expiration dates, transition policy deadlines (e.g., MDD extension to the end of 2027/2028), and new regulation adaptation milestones (e.g., battery carbon footprint declarations, DPP updates). Initiate preparations 3 months in advance.
2.Conduct regular self-inspections: Low-risk products verify material completeness semi-annually; medium-high risk products undergo annual compliance assessments by institutions. Medical devices require additional EUDAMED review material synchronization every 2 years.
3.Special management of transition products: Enterprises holding MDD/AIMDD certificates must complete extension certificate applications by Q2 2026 and initiate MDR conversion preparations to avoid delays from peak audit periods before the extension deadline.
2026 EU CE compliance is not about "having a certificate" but about "whether compliance details can withstand regulatory verification." Materials are the foundation of compliance, and dynamic maintenance is the guarantee. Combining both and anchoring the latest regulations will make CE certification a true "hard currency" for products to access the European market.
BLUEASIA Technology: +86 13534225140 provides professional certification consulting services.
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