August 2025 marks a non-negotiable strategic milestone for numerous smart hardware manufacturers. The EN 18031-2 standard under the EU Radio Equipment Directive officially enters mandatory enforcement—acting like a sophisticated security checkpoint at the entrance to the European market. However, common interpretations suffer from a fatal misconception: equating "wireless devices" with "products requiring certification." In reality, the trigger mechanism for this checkpoint is far more complex than the word "wireless." This article penetrates the surface to precisely define EN 18031-2’s true jurisdiction, revealing easily overlooked "mandatory items" and "exemptions."

Core Definition: Mandatory EN 18031-2 Wireless Device Certification

Whether your product requires EN 18031-2 certification does not depend on whether it is "smart" or "connected," but on whether its functional design meets two inseparable core conditions:

1.Equipped with wireless communication functionality: This is the physical foundation. The device must be capable of communication via radio frequency technology, including but not limited to:

·Short-range communication: Wi-Fi, Bluetooth, Zigbee, Thread, NFC.

·Cellular networks: 4G LTE, 5G NR.

·Other wireless technologies: LoRa, Sigfox, proprietary radio, etc.The key is that this functionality is an inherent part of the device’s design—not implemented via external adapters.

2.Its functionality "relies on" or "is used for" processing personal data/privacy information: This is the intersection of law and technology, and the difficulty of judgment. "Processing" includes any link in the collection, storage, transmission, access, or deletion of data. "Reliance" means that without this data processing capability, the device’s core or a major claimed function cannot be realized.

Simply put: An industrial sensor transmitting only anonymized device status (e.g., machine speed) via Bluetooth is not subject to jurisdiction; however, a smart door lock that only receives firmware updates via Wi-Fi but stores user identity information locally is subject to jurisdiction. Whether data can be linked to an identifiable natural person is the golden standard.

  Explicit Products & Programs for EN 18031-2 Wireless Device Certification

Based on the above logic, the following categories are clear targets for EN 18031-2 certification, with notified bodies accumulating extensive testing cases:

Category 1: Consumer Electronics & Smart Home (Core Risk Zones)

·Wearables: Smart watches, fitness bands (processing health data, location, identity).

·Home Monitoring & Security Devices: Smart cameras, video doorbells, baby monitors (processing images, audio, biometric data).

·Smart Home Appliances: Smart speakers/assistants (processing voice commands, voiceprints), smart TVs (processing viewing habits, account information).

·Connected Toys & Children’s Devices: Toys with voice interaction, cameras, or positioning functions (subject to stricter children’s data protection clauses).

Category 2: Specialized Scenarios & Emerging IoT Devices (Easily Underestimated)

·Connected Car Infotainment Systems: Processing driver preferences, contact lists, geographic locations, and even driving behavior data.

·Personal Health Devices: Non-medical continuous glucose monitors, connected blood pressure monitors, smart scales (processing sensitive health data).

·Smart Building Terminals: Smart access control, facial recognition attendance machines for employees or residents.

·Retail & Logistics Terminals: Smart POS machines with facial recognition, smart retail shelves collecting user behavior data.

  Key Clarifications: "Seemingly Required but Exempt" or "Seemingly Unrelated but High-Risk" Items

This is critical to avoiding misjudgments and saving compliance costs.

Common Exemptions or Cases Requiring Specific Analysis:

·Pure Industrial IoT Devices: Sensors in factories transmitting purely anonymized operational technology data (e.g., machine temperature, pressure, vibration) typically do not involve personal data.

·Devices Only Used to Establish Communication Links: Certain pure modems, routers, or gateways may not be directly applicable if they do not process the content of user data passing through them (e.g., no unpacking or analyzing data payloads). However, the end devices they connect to must comply.

·Devices Governed by Higher-Level Specialized Regulations: Active medical devices under the EU Medical Device Regulation (MDR) have higher-priority cybersecurity requirements but require assessment of overlaps with EN 18031-2.

Easily Overlooked "Gray Area" Products:

·"Functionally Degraded" Smart Devices: A smart light bulb whose app collects household electricity usage patterns and links them to user accounts for "energy-saving recommendations" triggers data processing.

·Personal Data in Enterprise-Grade Devices: A wireless conference system purchased by an enterprise that features voice transcription linked to speaker identities is processing personal data.

·Accessories & Components: A smart battery or motor with a built-in wireless module that processes data independently (e.g., charging cycles, performance data) linkable to end users may be considered an independent product requiring assessment.

EN 18031-2’s regulatory sword targets product innovation at the intersection of "wireless" and "privacy." In 2025, accurate self-definition of product "programs and products" scope is no longer an optional compliance exercise but a core reflection of an enterprise’s technical strategy and market risk management capabilities. For professional certification consulting, contact BLUEASIA at +86 13534225140.