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    EN 18031 harmonized stadards

    New Harmonised Standards Under the Radio Equipment Directive

    February 3, 2025
    RED – Radio Equipment Directive

    The European Commission has published references to the EN 18031 series in the Official Journal of the European Union, marking a significant step in regulatory compliance for manufacturers of radio equipment. These newly recognized harmonized standards help manufacturers demonstrate compliance with essential requirements 3(3)(d), 3(3)(e), and 3(3)(f) under the Radio Equipment Directive (RED) 2014/53/EU.

    Why New Harmonized Standards Matter

    The EN 18031 standards now serve as a reference for compliance with essential requirements 3(3)(d), 3(3)(e), and 3(3)(f) under RED. Before their publication, manufacturers had to rely on alternative routes, which often required direct involvement from a Notified Body. Now, these harmonised standards offer a streamlined path to compliance—but with some restrictions.

    Conformity Assessment Procedures and Their Impact

    Under Article 17 of the Radio Equipment Directive, manufacturers can choose between three Conformity Assessment Procedures:

    1. Internal Production Control – The most straightforward route, allowing manufacturers to assess and document compliance independently.
    2. EU-Type Examination Certification – Requires submission of compliance documentation to a Notified Body for review and approval.
    3. Full Quality Assurance – A rarely used, highly complex route that involves continuous monitoring.

    Manufacturers can only use Internal Production Control if they apply harmonised standards in full. If they do not fully apply the standards (even if no applicable harmonised standard exists), they must involve a Notified Body before placing their products on the market.

    Restrictions on the New Harmonized Standards

    While the EN 18031 standards have been harmonised, they come with certain restrictions. If a manufacturer’s product does not comply with these restrictions, the standard is not considered harmonised for their device—meaning they must go through a Notified Body.

    The restrictions are as follows:

    • EN 18031-1: Not harmonised if the product does not require a password for access (clauses 6.2.5.1 and 6.2.5.2).
    • EN 18031-2: Requires parental/guardian access controls (clauses 6.1.3–6.1.6).
    • EN 18031-3: Requires secure update mechanisms beyond those outlined in clause 6.3.2.4.

    Manufacturers must review these restrictions carefully to determine whether they can apply the harmonised standards or if they need Notified Body involvement.

    What Steps Should Manufacturers Take Now?

    • Review Your Risk Assessment – Identify any cybersecurity risks associated with your product and determine if the harmonised standards fully address them.
    • Apply Harmonised Standards If Possible – If your product meets all requirements, applying these standards can simplify the compliance process.
    • Engage a Notified Body If Needed – If any restriction applies to your device, be prepared to undergo EU-Type Examination Certification.
    • Monitor Future Updates – The European Commission and Notified Bodies may issue further clarifications or amendments.

    Final Thoughts

    With the August 1, 2025, compliance deadline approaching, manufacturers should act now to align their products with the EN 18031 series. While these harmonised standards provide a clear compliance route, their restrictions mean that many manufacturers will still need Notified Body involvement. Need help ensuring compliance with these new regulations? Contact us today for expert guidance and testing solutions.

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