Artifact GuideEU

EU RED Compliance evidence

A RED compliance file should prove that the exact radio equipment type meets the applicable Article 3 requirements, has followed the right conformity assessment route, and is supported by technical documentation, an EU declaration of conformity, labels, instructions, and CE marking records.

This guide helps structure the evidence package before placing connected devices, wireless products, receivers, transmitters, radio modules, or common-charger covered products on the EU market.

Author
Sorena AI
Published
May 9, 2026
Updated
Jul 25, 2026
Sections
5

Structured answer sets in this page tree.

Primary sources
11

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 25, 2026
Overview

A Radio Equipment Directive compliance record ties each released product configuration to RED scope, operator role, Article 3 requirements, harmonised-standard coverage, , technical documentation, EU declaration, CE marking, market information, retention, corrective action, and reassessment triggers. The manufacturer owns the demonstration even when it uses module reports, suppliers, test laboratories, or a notified body.

Section 1

Start with product scope and operator role

Define the radio equipment type, intended use, every operating configuration, software and accessories needed for operation, EU market, and economic-operator role. Check the Article 1 and Annex I exclusions before mapping obligations. The RED applies to commercial supply whether paid or free, and its roles distinguish the manufacturer, authorised representative, importer, and distributor.

The scope note should explain whether the finished product intentionally transmits, receives, or both; whether it is a module, kit, finished product, receiver, transmitter, or connected product; and whether common-charger or Article 10(10) restriction information is relevant. Keep this scope note with the technical documentation. A compliant radio module does not remove the host manufacturer's responsibility for the whole released equipment.

An importer or distributor that markets equipment under its own name or trade mark, or modifies equipment in a way that may affect conformity, becomes the manufacturer for RED purposes. Record that role change before assigning documentation, declaration, labelling, and corrective-action duties.

  • Record manufacturer, importer, distributor, or authorised representative responsibilities before approving labels, instructions, declarations, and market-release steps.
  • Tie each SKU, hardware revision, firmware version, radio module, antenna configuration, and supplied accessory to the same RED scope decision.
  • Flag country or spectrum-use restrictions early because Article 10(10) information may have to appear on packaging and in instructions.
Section 2

Map the Article 3 requirements before choosing tests

The compliance matrix should start with Article 3. At minimum, assess health and safety, electromagnetic compatibility, and efficient use of radio spectrum. Then decide whether a specific Article 3(3) requirement has been activated for the product category, including emergency access, privacy, fraud protection, network protection, accessibility, or software-combination obligations where relevant. Treat Article 3(4), Article 3a, and Annex Ia common-charger duties as a separate branch.

For internet-connected radio equipment and other categories covered by Delegated Regulation (EU) 2022/30, treat cybersecurity as a RED Article 3(3) evidence stream. The requirements apply to covered equipment placed on the market from 1 August 2025 through 10 December 2027. Delegated Regulation (EU) 2026/339 repeals the category act from 11 December 2027 but preserves RED surveillance for equipment placed on the market during that interval. Commission Implementing Decision (EU) 2025/138 cites EN 18031-1:2024, EN 18031-2:2024, and EN 18031-3:2024 with restrictions, so release decisions should identify the applicable part, the relevant Article 3(3) point, every limiting notice, and any remaining technical or conformity-assessment work.

  • Use an Article 3 matrix with columns for requirement, applicability rationale, harmonised standards or other specifications, test evidence, residual gaps, and owner.
  • Separate Article 3(1)(a) safety, Article 3(1)(b) EMC, Article 3(2) spectrum, and each applicable Article 3(3) duty so evidence does not blur across requirements.
  • For common-charger covered categories, include USB Type-C, charging communication, unbundling, pictogram, label, instructions, and distance-selling display evidence.
Section 3

Select the conformity assessment route

Choose the Article 17 route requirement by requirement. Article 3(1) and Article 3(4) may use internal production control, EU-type examination plus conformity to type, or full quality assurance. For Article 3(2) and Article 3(3), internal production control remains available only where the relevant OJEU-cited harmonised standards are applied for the covered requirements. If those standards are missing, not cited, not applied, only partly applied, or restricted so that a triggered requirement remains uncovered, use Annex III EU-type examination plus conformity to type or Annex IV full quality assurance for the affected requirement.

The standards record should distinguish between a standard that is useful engineering evidence and a harmonised standard whose reference has been published in the Official Journal for the exact RED requirement. That distinction matters because RED presumption of conformity only follows the cited harmonised standard coverage.

  • Keep the OJEU-cited harmonised-standard list with version, issue date, requirement coverage, applied clauses, exclusions, and withdrawal or transition notes.
  • Document why internal production control, EU-type examination plus conformity to type, or full quality assurance was selected.
  • If a notified body is used, retain the application, technical documentation package, EU-type examination certificate or quality-system records, and any certificate additions or restrictions.
Section 4

Build the technical file and declaration evidence

The technical documentation should be prepared before the radio equipment is placed on the market and should contain the data needed to assess conformity with Article 3. In practice, the RED file should connect design descriptions, manufacturing controls, risk analysis, standards rationale, test reports, software and accessory information, radio parameters, labels, instructions, and supplier inputs to the Article 3 matrix.

The EU declaration of conformity should identify the radio equipment type, list the relevant harmonised standards or other technical specifications, name any notified-body intervention where applicable, and be kept with the technical documentation. If the simplified EU declaration is supplied with the product, the exact internet address for the full declaration needs to be stable and product-specific.

  • Retain the technical documentation and EU declaration of conformity for 10 years after the radio equipment has been placed on the market; importers must keep a declaration copy available for the same period.
  • Check that CE marking is affixed only after the has been completed and the declaration has been drawn up.
  • Keep copies of labels, instructions, safety information, packaging artwork, Article 10(10) restriction statements, and common-charger pictograms as released artefacts.
  • Keep supplier and customer traceability information available for 10 years after the equipment was supplied to or by the economic operator.
Recommended next step

Turn RED evidence into a release checklist

This RED evidence structure helps review scope, Article 3 requirements, harmonised-standard coverage, notified-body needs, technical documentation, labels, declarations, and release blockers before EU market placement.

Section 5

Avoid weak RED compliance evidence

The most common evidence failure is a file that says a product is CE marked or RED compliant without showing how the exact Article 3 duties were met. A supplier declaration, lab report, voluntary certificate, or old test report is weak if it does not match the released radio configuration, firmware, antenna, charger option, label, market, or harmonised-standard status.

Reopen the evidence package when a radio module, antenna, enclosure, power supply, firmware, security posture, data flow, payment feature, accessory, charger bundle, intended use, market, standard, delegated act, or restriction changes; when a notified-body certificate may need an addition; or when complaints, incidents, or authority feedback question conformity.

  • Do not treat a non-notified voluntary certificate as a substitute for RED or market-surveillance evidence.
  • Do not cite a harmonised standard for presumption of conformity unless its reference and coverage match the RED requirement being claimed.
  • Do not release packaging, online listings, or instructions before checking Article 10(10), common-charger pictogram and label duties, CE marking, and declaration access.
Primary sources

References and citations

eur-lex.europa.eu
Referenced sections
  • General EU product-law guidance used for manufacturer responsibility, CE marking, declaration, and market-surveillance concepts alongside RED-specific rules.
"responsible for the conformity assessment"
eur-lex.europa.eu
Referenced sections
  • Binding source for formal non-compliance examples, including missing declaration, incomplete documentation, incorrect labels, and Article 10 information failures.
"technical documentation is either not available"
single-market-economy.ec.europa.eu
Referenced sections
  • Commission resource explaining notified bodies and conformity assessment bodies used when RED requires a third-party assessment route.
"designated Notified Bodies per directive"
single-market-economy.ec.europa.eu
Referenced sections
  • Commission warning on voluntary certificates and reminder that CE marking follows testing and the applicable conformity assessment procedure.
"CE marking can only be affixed after testing"
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