For manufacturers of wearables, smart home devices, and other wireless products, August 2025 has arrived—making EU EN 18031-2 mandatory certification a "current survival necessity" rather than a "future topic." Unlike most online articles that simply list documentation checklists or misconstrue "validity period" as a fixed number of years, this article reveals a core truth: EN 18031-2 certification documentation is not a static set of files but a dynamic "technical construction file system"; its "validity period" is not a one-time achievement but a rigorous "continuous compliance" mechanism. Understanding and implementing these two points is key for enterprises to control risks and maintain market access in the post-certification era.

Mandatory EU EN 18031-2 Certification Documentation

Preparing certification documentation is far more than filling out forms—it is a systematic demonstration to the notified body that privacy protection was integrated into the product’s "DNA" from the initial design stage. The core of this documentation system is a detailed "technical construction file," which must form a complete, unassailable evidence chain.

Core Document 1: Privacy Impact Assessment (PIA) Report—Compliance "Strategic Map"

This is the top-level design of all documents, directly determining the direction and depth of subsequent work. A qualified PIA must address:

·Data Processing Profile: Precisely list every personal data field collected, stored, transmitted, or deleted by the device (e.g., device ID, location trajectory, heart rate, voice command fragments), and specify the legal basis (e.g., necessary for contract performance or explicit user consent).

·Risk Identification & Mitigation: Assess the risk level of each data processing link to user rights (e.g., confidentiality, anonymization), and detail how technical and organizational measures (e.g., encryption, access control) reduce risks to acceptable levels.

·2025 Focus: The report must include a dedicated assessment of core principles such as "privacy by default" and "special protection for children." For example, if the product may be used by children, a separate assessment of the appropriateness of data collection and the effectiveness of parental controls is required.

Core Document 2: Data Flow & Security Architecture Diagrams—Compliance "Technical Blueprint"

This is the technical specification translating PIA strategy into action, which notified body auditors will review meticulously.

1.End-to-End Lifecycle Data Flow Diagrams: Use standard diagramming tools to clearly illustrate the full path of personal data from generation, local processing, encrypted transmission, cloud storage to final deletion. Label data format, encryption status (e.g., AES-256), retention period, and accessing parties at each node.

2.Security Architecture Specification:

·Hardware Security: Specify whether security chips or Trusted Execution Environments (TEE) are used, including their specific models and security certifications.

·Software Security: Detail identity authentication mechanisms, permission isolation models, secure boot processes, and firmware signing/updating mechanisms.

·Encryption Implementation: Clearly define static data encryption algorithms, key management schemes, and transport layer encryption protocols (must be TLS 1.2 or higher).

Core Document 3: User-Verifiable Documentation—Compliance "User Interface"

These documents bridge communication between the product, users, and regulators—must align absolutely with technical implementation.

·User Privacy Guide: In plain language, clearly inform users via the device or app: which data is being collected, why, how long it will be stored, and how to exercise rights to access, correct, delete, and data portability.

·Public Privacy Policy: Content must be consistent with the User Privacy Guide and technical documentation descriptions. In 2025, cases have emerged where certifications were challenged because privacy policies claimed "no voice storage," but technical logs showed audio fragment caching.

Core Document 4: Testing & Validation Reports—Compliance "Experimental Evidence"

This is key to proving "what is claimed is what is done."

·Internal Testing Reports: Cover test cases and results for all privacy and security functions, such as "whether factory resets trigger physical erasure" and "whether unauthorized attempts to access personal data are effectively blocked."

·Third-Party Penetration Testing Reports (for medium-to-high-risk products): Issued by independent security teams to simulate attacks and verify the effectiveness of security measures—this report is critical for gaining notified body trust.

  EN 18031-2 Certification Validity Period & Continuous Compliance

This is the biggest misconception. EN 18031-2 itself does not specify a "fixed validity period" for certificates, but compliance status is dynamic and conditional.

1."Permanent Validity" & "Continuous Supervision" of Notified Body CertificatesUpon passing notified body certification, you will receive an EU Type Examination Certificate. This certificate has no fixed expiration date and is theoretically valid indefinitely. However, this validity is subject to strict conditions:

·Annual Surveillance Audits: Certificate holders must undergo at least annual surveillance audits by the notified body to confirm that products continue to be manufactured in accordance with the certified type and that the quality management system operates effectively.

·Change Management: Any "major changes" that may affect product privacy and security compliance must be notified to and approved by the notified body before implementation. Major changes include: replacement of core chips/sensors, major operating system upgrades, changes to encryption algorithms or key lengths, or modifications to data storage logic or geographic locations.

·Invalidity Conditions: Failure to pass surveillance audits or unapproved major changes will result in certificate suspension or revocation—immediately revoking market access eligibility.

2."Dynamic Updates" of Declarations of ConformityThe legal validity of the Declaration of Conformity signed by the manufacturer based on the certificate is tied to the following factors:

·Certificate Status: As noted above, a invalidated certificate automatically invalidates the declaration.

·Standard & Regulation Updates: If the EU officially revises the RED Directive or harmonized standard EN 18031-2, manufacturers are responsible for assessing new requirements, updating products and technical documentation within the specified transition period, and re-ensuring compliance.

·Product Iterations: Even for the same model, software version upgrades involving privacy and security functions require updated technical documentation and an assessment of whether recertification is needed.

In short, the "validity period" of EN 18031-2 is a "living contract" requiring lifelong maintenance—its core is the enterprise’s "commitment to continuous compliance."

To address EN 18031-2, enterprises must transition from a "document preparation for certification" mindset to a "evidence system construction for risk management" mindset. A high-quality, maintainable set of technical documentation is not only a key to EU market entry but also the foundation for enterprises to build core product privacy competitiveness and navigate future global regulations. For professional certification consulting, contact BLUEASIA at +86 13534225140.