EU RED Cybersecurity Requirements Soon to Become Mandatory




The European Commission has adopted a delegated act under the Radio Equipment Directive (RED – 2014/53/EU), Delegated Regulation (EU) 2022/30, to strengthen the cybersecurity of internet-connected radio products in the European Union (EU). It applies from 1 August 2025.
EU RED Cybersecurity Requirements Soon to Become Mandatory – Figure 1
 1.

Implementing three essential requirements of the RED

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The delegated act activates three essential requirements in Article 3 of the Radio Equipment Directive, as follows:

  • 3(3)(d) Network protection: radio equipment must not harm the network or its functioning nor misuse network resources.

  • 3(3)(e) Protection of personal data and privacy: equipment must incorporate safeguards to protect the personal data and privacy of users and subscribers.

  • 3(3)(f) Protection from fraud: equipment must support features that ensure protection against fraud.

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2

The EN 18031 series of harmonised standards

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To meet these requirements, the European Commission has adopted the EN 18031 series as harmonised standards, each corresponding to one of the three RED requirements:

  • EN 18031-1: corresponds to 3(3)(d), focusing on network security requirements.

  • EN 18031-2: corresponds to 3(3)(e), covering personal privacy protection.

  • EN 18031-3: corresponds to 3(3)(f), focusing on protection against fraud.

3

Scope and assessment mechanism, in one chart:

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The EN 18031 series maps the assessment items to different security mechanism requirements (14 main items in total)

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4

Recommendations for companies

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With just over a month left before the act applies, time is short. To avoid products being barred from the EU market after 1 August 2025 for not complying with the EN 18031 series, companies need to prepare the following test materials in advance:

  • Product samples and related software and apps;

  • Product instructions and user manuals;

  • Test application form;

  • Technical documentation (including the software bill of materials (SBOM), security design documents, etc.);

  • Questionnaire answers (as the basis for the decision trees);

  • Existing cybersecurity test reports (e.g. reports against ETSI EN 303 645 or IEC 62443-4-2).

EU RED Cybersecurity Requirements Soon to Become Mandatory – Figure 9

END

Our services

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Everbiz has extensive hands-on experience in quality systems and product registration and can provide industry clients with professional consulting such as interpretation of the act and test guidance, helping companies meet regulatory challenges smoothly. If you have any questions, please contact us at any time.
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EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
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EU RED Cybersecurity Requirements Soon to Become Mandatory – Figure 15




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