In recent years, the EU's regulation of wireless devices has become increasingly stringent, with requirements for network security, privacy protection, and product fraud prevention constantly escalating. EN 18031 has become a crucial compliance threshold that exporting EU-bound enterprises cannot bypass.
For many manufacturers, facing new regulatory provisions often leaves them perplexed: What exactly do the standards entail? What are the hard constraints on product design, R&D processes, and testing and certification? And what are the actual risks of non-compliance, such as customs clearance obstacles, market entry bans, and brand damage?
In order to help enterprises no longer "cross the river by feeling the stones", CCL Shiding Testing has compiled this guide to interpreting EN 18031 regulations and designing enterprise compliance certification. We have broken down the core provisions into plain and easy-to-understand language, provided practical compliance design ideas based on the entire product lifecycle, and outlined the certification process, common pitfalls, and solutions. This guide aims to help R&D, quality, foreign trade, and compliance personnel quickly grasp the key points, avoid detours, reduce costs, and smoothly gain access to the EU market.
As of August 1, 2025, the cybersecurity requirements of the Radio Equipment Directive (RED) have been fully enforced. The EN 18031 series of standards, as harmonized standards officially announced by the European Commission, signifies that cybersecurity, alongside electrical safety and electromagnetic compatibility, has become a mandatory component of CE certification.
The legal basis for this standard stems from the Delegated Regulation (EU) 2022/30. Its core logic is to introduce a "risk-based security engineering" approach, mandating enterprises to perform systematic threat modeling from the very beginning of product design, rather than relying on traditional reactive testing. This means that cybersecurity is no longer an "additional option" for products, but rather a "basic configuration" that must be built-in.
EN 18031-1 (General Cybersecurity): Targeted at all devices capable of accessing public communication networks via wireless means (Wi-Fi, Bluetooth, cellular networks, etc.), such as routers, smart home appliances, industrial sensors, etc. The core requirements encompass 13 testing items, including software integrity verification, secure storage and communication, strong authentication, and secure software update mechanisms. EN 18031-2 (Data Privacy Protection): This standard applies to devices that handle personal data or are used for childcare, such as smartwatches, baby monitors, and smart speakers with cameras. The focus lies in privacy protection design, data deletion mechanisms, and the mandatory implementation of parental controls. EN 18031-3 (Financial Transaction Security): Targeted at devices handling virtual currencies or monetary value, such as POS machines, cryptocurrency wallets, vending machines, etc. It requires tamper-proof design, secure boot, log auditing, and the integrity and traceability of key transaction processes.
(1) Two major options for certification paths
Most products can adopt the Declaration of Conformity (DoC) route: after completing testing based on EN 18031, the manufacturer signs the Declaration of Conformity and affixes the CE marking before the product can be placed on the market.
However, the following three types of situations must undergo mandatory certification through a Notified Body in the EU to obtain an EU-Type Examination Certificate (EU-TEC):
1. The device does not support user authentication: such as allowing password-free use or being unable to enforce password settings
2. Involving children's use and lacking parental control: For example, children's smartwatches do not implement unbypassable parental control
3. Involving financial transaction functions: such as payment terminals, cryptocurrency wallets, etc
(II) Action Guide for Corporate Compliance Design
Phase 1: Gap analysis in the early stages of development
1. Evaluate the existing capabilities of the product item by item against the requirements of each part of EN 18031, with a focus on default password policies, data encryption strength (AES-256 or equivalent is recommended), signature verification of firmware update mechanisms, and anti-rollback design.
2. Complete the threat modeling document, including attack tree analysis and risk quantification matrix - this is the focus of the certification authority's review.
Phase 2: Incorporating Security Design
1. Adopt the "Security by Design" philosophy, considering security capabilities from the very beginning of chip selection.
2. Choosing certified wireless modules (Wi-Fi, Bluetooth) can effectively reduce testing costs and enhance compliance consistency.
3. Hardware level: Implement Secure Boot, establish hardware-level root trust, and automatically verify the bootloader and operating system signatures upon power-on to prevent malicious firmware implantation.
4. Communication layer: Mandatory use of TLS 1.2/1.3 and X.509 certificate authentication to ensure encrypted data transmission.
5. Access control: Eliminate generic or weak default passwords, and implement multi-factor authentication and the principle of least privilege.
Phase 3: Document preparation and testing
1. Fully prepare technical documents: architecture diagram, communication protocol description, encryption process, user authentication mechanism, key management scheme, and proof of true random number generation.
2. Submit samples that meet mass production standards and cooperate with the laboratory to conduct penetration testing (black box/white box), vulnerability scanning (covering OWASP IoT Top 10), and fuzz testing.
3. Special note: It is required to cover 100% remediation of CVE high-risk vulnerabilities.
Phase 4: Certification and Continuous Maintenance
After completing the test, submit it for review through a certification body to obtain a certificate.
2. Establish a vulnerability monitoring mechanism for the entire product lifecycle, and commit to providing security updates within a reasonable lifespan.
