Artifact GuideEU RED

RED software update impact for radio equipment

Software and firmware changes can affect RED conformity when they change radio behavior, intended use, cybersecurity functions, charging information, user-configurable features, or the assessed equipment/software combination.

Use this page to decide when an update needs a conformity review, technical-file update, declaration update, standards check, or notified-body follow-up before release.

Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Sections
4

Structured answer sets in this page tree.

Primary sources
7

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

Under the Radio Equipment Directive, software is part of the compliance record when it affects essential requirements or allows the radio equipment to operate as intended. RED Article 3(3)(i) also allows the Commission to require features ensuring that software can only be loaded where the compliance of the radio-equipment and software combination has been demonstrated. A practical update review therefore asks whether the release changes the product configuration that was assessed, documented, declared, or certified.

Section 1

When a software update can affect RED conformity

Treat each update as a product-change assessment, not as a routine engineering label. The first question is whether the change can alter an Article 3 requirement: health and safety, EMC, efficient spectrum use, an activated Article 3(3) requirement, or the common-charger information and charging-capability rules for covered equipment.

The RED technical documentation must identify software or firmware versions that affect compliance with essential requirements. The release-control record should also monitor hardware and software changes, standards, legal developments, and state of the art. That makes the record important even when the conclusion is that no retest or declaration change is needed.

  • Review updates that change transmitter power, frequency bands, modulation, duty cycle, antenna behavior, receiver parameters, geofencing, or region selection.
  • Review updates that change cybersecurity controls for internet-connected, data-processing, wearable, childcare, toy, or payment-capable radio equipment covered by Delegated Regulation (EU) 2022/30.
  • Review updates that add or remove user-installable software, companion-app control, accessories, components, charging behavior, restriction information, or operating modes described in the instructions or declaration.
  • Record a no-impact decision only when the assessed model, hardware variant, firmware or software version, intended use, standards coverage, and market information remain aligned.
Recommended next step

Review RED software-change evidence before release

Check whether a firmware, app, OTA, or configuration update changes the Article 3 matrix, standards evidence, technical file, declaration, notified-body record, or release approval for radio equipment.

Section 2

Update the technical file before release

The update record should let a reviewer connect the software release to the radio equipment type placed on the EU market. Keep the release identifier, affected models, affected hardware variants, changed radio or security functions, standards impact, test impact, DoC impact, notified-body impact, approval owner, and release decision.

Annex V is the anchor for the file: it calls for a general product description, conceptual design and manufacturing materials, software or firmware versions affecting compliance, user and installation information, harmonised standards or other technical specifications, EU declaration, EU-type examination material where applicable, calculations, examinations, and test reports. If the update affects any of those records, update the technical documentation instead of relying on release notes alone.

  • Link each software or firmware version that affects RED compliance to the exact model, type designation, hardware revision, region configuration, and release channel.
  • Add regression evidence for the Article 3 requirements touched by the change rather than retesting unrelated requirements by default.
  • Update instructions, safety information, restriction information, frequency-band and power information, and DoC software descriptions when the user-facing compliance description changes.
  • Keep the technical documentation and EU declaration available for 10 years after the radio equipment has been placed on the market.
Section 3

Check standards and notified-body consequences

A software update can reopen the conformity-assessment route if the change affects a requirement that was covered by a harmonised standard, a partly applied standard, a technical specification, an EU-type examination certificate, or a full-quality-assurance approval. RED gives presumption of conformity only for the essential requirements covered by OJEU-published harmonised standards or parts of standards.

For Article 3(2) and Article 3(3), the notified-body question is especially important. If relevant OJEU-cited harmonised standards are not applied, are applied only in part, or no such standards exist for the requirement being assessed, Article 17 points the manufacturer to Annex III or Annex IV rather than Annex II for those requirements. For Annex III, modifications to the approved type that may affect conformity or certificate validity require additional approval.

  • Compare the update against the exact standard versions, clauses, restrictions, and test configurations used for the current declaration.
  • If a standard has lost presumption of conformity for products not yet placed on the market, decide whether the updated product needs a new standard route or notified-body route.
  • For Annex III certificates, ask whether the update changes the approved type, certificate conditions, software version, radio configuration, or evidence reviewed by the notified body.
  • For Annex IV quality-system approvals, check whether the update changes a design, production, inspection, testing, or quality-system control covered by the approval.
Section 4

Common mistakes in RED software-change records

The main mistake is treating firmware as outside RED because no physical component changed. That is too narrow: software can affect radio parameters, EMC behavior, safety functions, cybersecurity controls, restrictions, charging behavior, instructions, and the evidence package used to place the equipment on the EU market.

The second mistake is treating every update as a brand-new conformity assessment. A documented impact decision can be proportionate, but it must explain why the existing Article 3 matrix, standards evidence, technical documentation, DoC, and notified-body records still cover the released configuration.

  • Do not ship an over-the-air update that changes radio or security behavior without checking the assessed equipment/software combination.
  • Do not leave the DoC, instructions, software identifiers, or technical file pointing to an older firmware version when the update affects compliance evidence.
  • Do not rely on a supplier or lab statement unless it identifies the affected model, software version, requirement, standard, and test or assessment basis.
  • Do not cite a harmonised standard for presumption of conformity unless the reference is published for RED in the Official Journal and covers the requirement and product configuration being claimed.
Primary sources

References and citations

eur-lex.europa.eu
Referenced sections
  • Supports horizontal EU product-law context for manufacturer responsibility, technical documentation, declarations of conformity, and CE-marked product controls.
"The manufacturer is responsible"
eur-lex.europa.eu
Referenced sections
  • Supports Article 4 software-combination information, Article 10 corrective action duties, and Annex V software or firmware documentation.
"continuously updated"
single-market-economy.ec.europa.eu
Referenced sections
  • Supports the role of notified bodies where third-party conformity assessment is required.
"assess the conformity"
single-market-economy.ec.europa.eu
Referenced sections
  • Supports RED implementation context, guidance links, harmonised-standard resources, and Commission warnings about conformity-assessment evidence.
"CE marking can only be affixed"
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