As Europe moves aggressively toward securing connected products, EN 18031-1 has quickly become one of the most important standards for manufacturers of IoT, industrial devices, and embedded systems. It sits at the heart of the EU RED Article 3.3 (d/e/f) cybersecurity requirements, forming the technical basis for demonstrating secure design, secure operation, and resilience against abuse or unintended misuse.

If you are a product manufacturer selling into the EU, EN 18031-1 is no longer optional. It has been mandatory since August 1st, 2025 and is the foundation of your cybersecurity conformity assessment and soon a prerequisite for CE Marking once the upcoming RED Delegated Act becomes fully enforced.

What is EN 18031-1?

EN 18031-1 is the core horizontal standard in the EN 18031 series. EN 18031 is a European standard that defines cybersecurity requirements for internet connected radio equipment. Part 1 addresses:

  • The baseline security requirements for all “radio-equipped products that process data.”
  • A harmonized methodology to demonstrate resilience against cybersecurity threats.
  • A common framework to validate a product’s robustness at the firmware, software, and configuration levels.
  • Data flows and communication protocols

Whereas RED Article 3.3d describes what must be achieved, EN 18031-1 describes how to prove it.

What Is the Purpose of EN 18031-1?

The standard exists to ensure that radio devices:

  1. Protect network integrity
    Prevent devices from degrading network performance (Article 3.3(d)).
  2. Protect personal data and privacy
    Assure proper authentication, access control, encryption, and data handling (Article 3.3(e)).
  3. Are protected from fraudulent or malicious use
    Hardened against tampering, exploitation, and unauthorized control (Article 3.3(f)).

In short, EN 18031-1 acts as the new “security baseline” for almost all connected products.

Scope: What Types of Devices Does EN 18031-1 Apply To?

The standard applies broadly to products that:

  • Use radio interfaces (Wi-Fi, BLE, cellular, LoRaWAN, UWB, proprietary RF, etc.).
  • Process or store any form of user or system data.
  • Communicate with cloud services or mobile apps.
  • Use embedded firmware capable of update, storing secrets, or performing networking tasks.

Examples include:

  • IoT appliances
  • Industrial sensors and controllers
  • Gateways and routers
  • Telemetry devices
  • Consumer wearables
  • Automotive accessories
  • Environmental monitoring devices
  • Robotics and drones
  • Medical IoT (supplementary to MDR requirements)

EN 18031-1 is one of the most widely applicable cybersecurity standards ever introduced for CE compliance.

Key Requirements of EN 18031-1

EN 18031-1 breaks down into several requirement families:

1. Secure Boot and Firmware Integrity

  • Mechanisms to ensure firmware has not been altered.
  • Protection of boot chain and system trust anchors.
  • Anti-rollback protections for updates.

2. Cryptographic Requirements

  • Use of well-established, modern cryptography.
  • Protection of keys (CCKs – confidential cryptographic parameters).
  • Secure key storage and lifecycle management.
  • No use of deprecated primitives.

3. Access Control & Authentication

  • Enforced credential creation on first use.
  • Password strength rules.
  • Protection of privileged interfaces (debug ports, maintenance channels, shell access).
  • Segregation of roles (user, admin, system).

4. Network Security

  • Protection against malformed frames, replay, spoofing.
  • DoS resilience testing.
  • Protocol-level validation for wireless interfaces.
  • Secure onboarding (BLE pairing, Wi-Fi provisioning, secure commissioning, etc.).

5. Update Mechanisms

  • Authenticated updates only.
  • Ability to revoke compromised keys.
  • Recovery process for failed updates.
  • Documentation proving update security.

6. Logging & Monitoring

  • Minimal audit trail on the device.
  • Secure delivery of logs.
  • Protection against log tampering.

7. Privacy & Data Protection

  • No default insecure data transmission.
  • Encryption in transit.
  • Hardening of local interfaces (serial, USB, maintenance ports).
  • Minimization of PII exposure.

8. Security Documentation Requirements

  • Structured ICS (Implementation Conformance Statement).
  • IXIT (Implementation eXtra Information for Testing).
  • Threat catalog and risk rationale.
  • Evidence of secure implementation choices.

Implementation Challenges Manufacturers Typically Face

Most organizations underestimate the effort required to meet EN 18031-1. Systemic issues include:

Legacy Systems

Many products environments contain legacy systems that were never designed with cybersecurity in mind. Organizations must balance security requirements with operational continuity and safety considerations.

Budget and Time Constraints

Budget and timeline are always the two most important factors in product development and implementing cybersecurity often requires significant investment in both time and resources

Skills Gap

Finding personnel with both development and cybersecurity expertise remains challenging. Organizations need comprehensive training programs to bridge this gap.

Organizational Communication

Without effective communication between engineering, security, QA and compliance teams successful implementation of EN 18031-1 will be difficult.

Common Compliance Issues that Arise From These Systemic Challenges Include:

1. Lack of Documentation

Many manufacturers have secure features — but no documentation, no diagrams, and no formal evidence for secure communication channels, best practice key generation and management, DoS resilience, password policies, etc.

2. Weak Cryptographic Key Handling

Hard-coded keys, derived secrets, or storing private keys in user-accessible partitions are among the top failure modes.

3. Unprotected Debug & Hardware Interfaces

JTAG, UART, reset pins, or shell interfaces left in “factory mode” are a primary source of exploitation.

4. Poor Password Policies

EN 18031-1 mandates forced credential setup and rejects common/weak passwords. Devices shipping with factory default credentials often fail.

5. Update Mechanisms Not Validated

Unsigned firmware update processes cause immediate non-conformity.

6. Overly Open Network Services

Standard failure examples include:

  • Unauthenticated web admin pages.
  • Unsafe PXE, TFTP, or provisioning endpoints.
  • Open debug daemons or test ports.

7. Misalignment Between Engineering and Compliance

Engineering teams often build features without documenting compliance intent, creating gaps in the SBOMs, IXIT and ICS.

Why EN 18031-1 Matters for Organizations

While compliance can require significant investment, the benefits are substantial:

  • Mandatory for CE Marking under RED 3.3(d/e/f) once the Delegated Act is enforced.
  • Reduces attack surface dramatically, improving overall system reliability.
  • Prevents product recalls and vulnerabilities and protects against costly cyber incidents.
  • Gives a competitive advantage by demonstrating secure-by-design architecture.
  • Strengthens customer trust by demonstrating commitment to security.
  • Prepares organizations for the upcoming Cyber Resilience Act (CRA), where similar requirements appear.
  • Potentially reduce cyber insurance premiums

Most importantly, EN 18031-1 forces manufacturers to mature their firmware, update infrastructure, and credential systems — areas historically neglected in IoT.

Conclusion

EN 18031-1 compliance is not just about checking boxes—it's about fundamentally improving the security posture of critical industrial systems. EN 18031-1 is going to transform how manufacturers build and maintain connected products. It demands not only secure implementation but evidence, traceability, and systemic security thinking.

Organizations that take a proactive approach to implementation will find themselves significantly ahead of both competitors and regulatory deadlines. They will better positioned to prevent cyber incidents and maintain operational continuity in an increasingly threat-filled environment.

At XtraByte Cybersecurity, we specialize in helping organizations navigate the complexities of EN 18031-1 compliance. We deliver full-service conformance packages tailored to your equipment, budget, and needs.