For manufacturers of smart watches, wireless cameras, and even connected toys, August 1, 2025, marks an unignorable watershed. On this date, the EU’s new privacy and security barrier for wireless devices—the EN 18031-2 standard—moves from paper to mandatory enforcement. This means non-compliant products will be legally barred from the EU market. However, many enterprises face a critical misconception: assuming that passing standard testing equates to obtaining a "CE" pass. The reality is far more complex—a provision known as "Limitation of Presumption of Conformity" could render all efforts futile, forcing enterprises to take the more costly and time-consuming notified body certification pathway.

I. Core of the New Mandatory EU EN 18031-2 Wireless Device Certification

EN 18031-2 is not an independent, optional voluntary standard. It is the specification and harmonized standard for core cybersecurity requirements under the EU Radio Equipment Directive (RED 2014/53/EU). Its legal basis stems from the Supplementary Delegated Regulation (EU) 2022/30 issued by the European Commission in 2022, which explicitly establishes cybersecurity, privacy protection, and anti-financial fraud as the three fundamental requirements of the RED Directive. The EN 18031 series standards serve as the "technical answer key" to these three requirements:

·EN 18031-1: Corresponding to "Ensuring Networks and Services" (Article 3.3(d)), focusing on general cybersecurity.

·EN 18031-2: Corresponding to "Protecting Personal Data and Privacy" (Article 3.3(e)), the focus of this article.

·EN 18031-3: Corresponding to "Preventing Fraud" (Article 3.3(f)), targeting financial payment devices.

Since late January 2025, the series has been officially recognized as harmonized standards by the EU. Thus, compliance with EN 18031-2 creates a legal "presumption" of meeting RED’s privacy protection requirements—this is a prerequisite for legally affxing the CE mark and selling in the European Economic Area (EEA, including the 27 EU member states plus Iceland, Norway, and Liechtenstein).

  II. Products Subject to Mandatory EU EN 18031-2 Wireless Device Certification

EN 18031-2’s jurisdiction is clear and targeted, covering two main categories of devices:

1.Internet-connected radio equipment that processes personal privacy data: This is the primary category, encompassing most consumer IoT products such as smart home devices, wearable health monitors, smart door locks, and security cameras.

2.Three specific types of radio equipment without internet connectivity but involving sensitive privacy: A key feature of the standard—even non-connected devices fall under EN 18031-2 if they belong to the following categories:

·Radio equipment for toys

·Radio equipment for child care

·Wearable radio equipment

Important Exemptions:

Notably, certain industries are governed by higher-level specialized regulations and are thus exempt from this RED requirement. These primarily include medical devices under the EU Medical Device Regulation (MDR) and some aerospace and automotive electronics.

  III. Critical Pitfalls of EU EN 18031-2 Wireless Device Mandatory Certification

This is the most common and impactful area for enterprises to stumble. According to official documents and authoritative notified body interpretations, the EN 18031 standard is "not considered fully harmonized" under specific circumstances—meaning its "presumption of conformity" is lost. In such cases, manufacturers cannot claim compliance through self-declaration (DoC) alone but must engage an EU-designated notified body for independent EU Type Examination Certification, a more rigorous process.

Key Triggering Conditions:

·The device allows users to operate without setting or using a password: If the product is designed to permit password skipping or password-free use, the entire presumption of conformity under EN 18031-1/-2/-3 is lost.

·Child-specific devices fail to ensure access control is exclusively implemented by parents/guardians: For children’s toys or care equipment, if access control mechanisms can be circumvented by children or are not exclusively managed by parents, the presumption of conformity under EN 18031-2 is lost.

·Inadequate security update mechanisms: For devices involving financial transactions (subject to EN 18031-3), relying solely on a single method (e.g., only digital signatures) for security updates is insufficient and will also invalidate the presumption of conformity.

Enterprises must first conduct internal self-audits. If the product involves any of the above scenarios, immediate planning for the notified body certification pathway is required—rather than simple self-declaration.

  IV. Analysis of Core EN 18031-2 Certification Requirements

The standard builds an assessment system around "asset" protection, focusing on "security assets" and "privacy assets." Its requirements can be summarized into the following technical and management key points:

1.Access Control Mechanisms: Ensure only authorized users can access the device and data. For child-specific devices, uncircumventable parental controls must be implemented.

2.Secure Storage and Communication: Sensitive data stored locally must be protected through encryption; external communications (e.g., data uploads) must use secure protocols such as TLS 1.2 or higher to ensure confidentiality.

3.Data Lifecycle Management:

·Erasure Mechanism: The device must provide effective functionality to allow users to permanently delete their personal data.

·Logging: Record critical security and privacy events (e.g., data access, permission changes) for auditing purposes.

4.User Awareness and Control: When privacy protection methods change, the device must notify users through effective mechanisms and explain the impact.

5.Security Update Mechanism: The device must have the capability to receive secure and reliable software/firmware updates to fix vulnerabilities.

  V. Practical Enterprise Compliance for EU EN 18031-2 Wireless Device Mandatory Certification

Facing this mandatory hurdle, enterprises need a systematic compliance roadmap. The entire process typically takes 4 to 8 months, and longer for complex or high-risk products.

Phase 1: Gap Analysis and Preparations (Approx. 1-2 Months)

·Standard Interpretation and Product Classification: Clarify which parts of EN 18031-1, -2, -3 apply to the product. Focus on self-auditing against the "Limitation of Presumption of Conformity" clauses.

·Technical Documentation Preparation: Begin compiling technical files, risk assessment reports, data flow diagrams, encryption algorithm descriptions, etc.—the core of notified body audits.

·Pre-testing and Rectification: Conduct internal or third-party pre-testing before official submission, addressing common issues such as default passwords, weak encryption, and inadequate parental controls.

Phase 2: Formal Certification Process (Approx. 3-6 Months)

1.Select Conformity Assessment Pathway:

·Self-Declaration (Internal Production Control, Module A): Only applicable for low-risk devices that fully meet the standard and do not trigger "Limitation of Presumption of Conformity" clauses.

·Notified Body Certification (EU Type Examination, Module B): Required for all high-risk devices and those triggering limitation clauses. Must be conducted through a notified body authorized by the EU NANDO database.

2.Laboratory Testing: Submit prototypes to qualified laboratories for comprehensive testing against the standard. Testing typically takes 4-12 weeks, and longer for financial devices.

3.Body Audit and Certification Issuance: The notified body reviews test reports and all technical documentation, issuing a certificate upon approval. This process takes 1-8 weeks.

Phase 3: Post-Certification Maintenance

Certification is not a one-time effort. Enterprises must establish a vulnerability management mechanism to ensure timely security updates throughout the product lifecycle. For enterprises holding notified body certificates, annual surveillance audits are usually required.

The battle for EN 18031-2 compliance is ostensibly a contest of technical standards, but in essence, a test of product privacy design philosophy and legal risk management capabilities. For enterprises aspiring to the EU market, overcoming this barrier not only grants a market entry pass but also lays a solid foundation for building consumer trust and enhancing brand reputation. For professional certification consulting, contact BLUEASIA at +86 13534225140.