Effective August 1, 2025, any wireless connected device sold in the EU that processes personal data as part of its core functionality must comply with the EN 18031-2 standard—failure to do so will result in market access denial. This article provides an in-depth analysis of the standard’s authoritative positioning, precise scope of application, 7 mandatory technical compliance requirements, and the distinction between "Self-Declaration" and "Mandatory Certification" pathways. Equipped          with 2025’s latest case studies, it serves as an indispensable manual for export enterprises to mitigate risks and ensure market entry.

Beyond Cybersecurity: Privacy Compliance Becomes an EU "Hard Ticket" to Market

With the full enforcement of Regulation (EU) 2022/30, the EU has established a three-tier product compliance framework under the Radio Equipment Directive (RED), centered on the EN 18031 series standards: cybersecurity (EN 18031-1), personal data and privacy protection (EN 18031-2), and anti-financial fraud (EN 18031-3). Among these, EN 18031-2:2023+A1:2024, as the official harmonized standard for privacy protection under RED, holds critical importance—compliance with this standard creates a legal presumption of meeting the mandatory privacy requirements outlined in Article 2(i) of RED Annex VI, offering enterprises the most direct and authoritative path to demonstrate compliance and gain market access.

I. Is Your Product Subject to EN 18031-2 Jurisdiction?

Not all connected devices fall under EN 18031-2. Its scope follows a precise "three-element" test, centered on data processing:

·Utilizes wireless communication: Such as Wi-Fi, Bluetooth, cellular networks (4G/5G), LoRa, etc.

·Processes personal data: "Personal data" is defined consistently with GDPR—any information that directly or indirectly identifies a natural person (e.g., device ID, location, heart rate, voice commands, usage habits).

·Data processing is a core function: Privacy protection is a primary design consideration, not an add-on feature.

Typical Applicable Products:

·Consumer electronics: Smart wearables (watches/bands), smart home cameras/speakers, child monitoring devices, connected toys, smart TVs.

·Connected car: Telematics terminals with remote data processing or driving behavior analysis.

·Health: Connected health monitoring devices (non-medical grade).

Explicitly Excluded Scenarios:

·Devices processing only anonymized data (cannot be linked to specific individuals).

·Pure Industrial Internet of Things (IIoT) sensors (e.g., collecting factory ambient temperature/humidity or machine vibration data unlinked to employee identities).

·Devices that are connected but whose core functionality does not involve processing user personal data.

  II. From GDPR Principles to Product-Level "Technical Hard Metrics"

EN 18031-2 translates GDPR’s legal principles into 7 specific technical requirements that must be embedded in product design:

1.Privacy by Design & by Default: Privacy protection must be an inherent part of the product architecture. For example, all non-core data collection functions (e.g., location tracking, voice recording, behavior analysis) must be disabled by default during new device initialization and require active user activation.

2.Data Minimization: The personal data collected, stored, and transmitted by the device must be limited in type, quantity, and retention period to what is strictly necessary for its stated specific functions. "Over-collection" is prohibited.

3.Explicit and Valid User Consent: Any data processing beyond what is required for core functions (e.g., for marketing analytics) must obtain the user’s free, specific, informed, and unambiguous consent. Consent mechanisms must be clearly presented in the device interface, offering equal "Yes/No" options without using dark patterns to induce consent.

4.Prevention of Unauthorized Access: Technical and organizational measures must be implemented to protect personal data—this is not a slogan but an explicit technical requirement:

·Static data encryption: Personal data stored locally on the device (e.g., user profiles, history) must use AES-256 or equivalently strong encryption algorithms.

·Transmission encryption: All personal data in transit must use TLS 1.2 or higher security protocols.

·Secure storage: Sensitive information such as encryption keys and certificates must not be hardcoded in firmware, but stored in protected hardware areas like Secure Elements (SE) or Trusted Execution Environments (TEE).

5.Data Erasure and Portability: When users exercise their "right to be forgotten" or reset the device to factory settings, secure and irreversible physical erasure must be implemented (not just logical deletion). All relevant data in caches and backup partitions must be 同步 cleared, and users must receive clear confirmation of successful erasure.

6.Special Protection for Children: If the device is likely to be used by children (typically under 12 years old in the EU), stricter requirements apply:

·All non-essential data upload and social functions must be disabled by default.

·Parental control functions must be "hardware/firmware-level" restrictions, uncircumventable through unauthorized means (e.g., rooting, cracking).

·Collecting biometric data (e.g., facial recognition, fingerprints) of children is generally prohibited unless the function is indispensable to the device’s core operation and explicit guardian authorization is obtained.

7.Documentation of Privacy Design Processes: Enterprises must create and maintain a complete set of privacy design documents as evidence for the Declaration of Conformity—this is the core of notified body audits.

  III. 2025 Compliance Implementation Roadmap

1.End-to-End Data Flow Mapping & Privacy Impact Assessment (PIA)Map the full product lifecycle data flow, precisely documenting data fields collected, storage locations, encryption status, transmission protocols, retention periods, and legal basis at each stage. Based on this, complete a PIA report to identify high-risk processing activities.

2.Privacy-by-Design Gap AnalysisCompare existing product design, software architecture, and configurations against the 7 core requirements outlined above. Focus on critical questions: Are default settings the most privacy-preserving? Is the consent prompt compliant? Does encryption meet standards? Is the erasure mechanism thorough?

3.Technical Implementation & Default Setting Restructuring

·Modify firmware to disable data collection functions by default.

·Integrate hardware security chips (if applicable) or enhance software encryption modules.

·Restructure the factory reset process to ensure physical-level data erasure.

4.Documentation System Construction (Core for Notified Body Audits)Prepare the following mandatory documents to form a complete evidence chain:

·Privacy Impact Assessment (PIA) Report

·Data Flow and Lifecycle Management Specification

·Privacy Design and Technical Implementation Specification (detailing how the 7 requirements are met)

·User Privacy Control Operation Guide

·Test Reports (including security testing and privacy function validation testing)

EN 18031-2 compliance is no longer optional but a mandatory technical regulation for EU market entry from 2025 onward. It requires enterprises to transform privacy protection from paper policies into inherent design philosophy and technical backbone. Early planning, precise alignment, and systematic implementation not only mitigate market access risks and legal liabilities but also earn the growing privacy trust of European consumers, translating into sustainable competitive advantages. For professional certification consulting, contact BLUEASIA at +86 13534225140.