Artifact TemplateEU

RED Conformity Assessment Template

This template helps document conformity assessment for radio equipment under Directive 2014/53/EU before EU market placement.

It covers product identity, Article 3 requirement mapping, Article 17 route selection, harmonised standards, notified-body records, Annex V technical documentation, EU declaration, CE marking, cybersecurity, common-charger fields, and change triggers.

Author
Sorena AI
Published
May 9, 2026
Updated
Jul 25, 2026
Sections
6

Structured answer sets in this page tree.

Primary sources
9

Cited legal and guidance references.

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

This RED template is for manufacturers documenting that radio equipment meets Directive 2014/53/EU before CE marking and EU market placement. The record should show the radio equipment type and configuration assessed, the applicable Article 3 requirements, the Article 17 conformity route, the standards or technical specifications used, the notified-body evidence where required, and the release evidence that supports the EU declaration of conformity.

Section 1

Product identity and RED scope fields

Start with product identity precise enough to match the label, packaging, instructions, EU declaration of conformity, test reports, technical documentation, production records, and any notified-body certificate. RED applies to equipment that intentionally emits or receives radio waves for radio communication or radiodetermination, subject to the Directive's exclusions.

The scope section should also record the intended operating conditions and every supported configuration, because Article 17 requires to consider all intended operating conditions and, where equipment can take different configurations, all possible configurations.

  • Product name, radio equipment type, model, type, batch or serial number, hardware revision, radio module, antenna configuration, accessories, and software or firmware versions affecting compliance.
  • Manufacturer name, registered trade name or trade mark, postal contact address, authorised representative if used, importer if known, and intended EU or EEA markets.
  • Radio functions, transmit and receive capability, frequency bands, maximum radio-frequency power, intended use, installation environment, user group, and foreseeable operating conditions.
  • Configuration boundaries: antennas, power supplies, accessories, software options, regional settings, installation modes, and any restrictions needed for compliant operation in at least one Member State.
  • Out-of-scope or parallel-law note: record any RED exclusion considered and any other Union CE-marking legislation included in the same release pack.
Section 2

Article 3 requirement and standards matrix

Use the main matrix to connect each applicable Article 3 requirement to the evidence that demonstrates conformity. Do not let a standards list stand in for the assessment: record whether the harmonised standard reference is published in the Official Journal, whether it was applied in full or in part, which clauses cover the requirement, and what evidence covers any gap.

The matrix should separate Article 3(1)(a) health and safety, Article 3(1)(b) electromagnetic compatibility, Article 3(2) efficient spectrum use, Article 3(3) additional requirements where activated, and Article 3(4) common-charger capability where applicable.

  • Requirement row: Article reference, requirement summary, applicable or not applicable decision, rationale, owner, and approval status.
  • Standards row: standard number, title, version, OJEU status, full or partial application, clauses applied, exclusions, and uncovered parameters.
  • Evidence row: test report, design calculation, risk assessment, cybersecurity analysis, radio spectrum assessment, EMC evidence, safety evidence, supplier record, or technical specification.
  • Route trigger row: whether Annex II remains available or whether Annex III or Annex IV is required for Article 3(2) or Article 3(3) because harmonised standards do not exist, were not applied, or were only partly applied.
  • Change-control row: owner and review date for standard revisions, delegated acts, firmware changes, antenna changes, radio-parameter changes, supplier changes, and intended-use changes.
Section 3

Article 17 route and notified-body evidence

The route section should state which procedure was used for each requirement group. Annex II is internal production control. Annex III is EU-type examination followed by conformity to type based on internal production control. Annex IV is conformity based on full quality assurance.

For Article 3(2) and Article 3(3), Annex II is available where the manufacturer has applied OJEU-published harmonised standards for the relevant requirements. If those standards do not exist, are not applied, or are applied only in part, record the Annex III or Annex IV notified-body route and keep the required evidence. Make this decision for each essential requirement because one cited standard may cover only part of the product's requirement matrix.

  • Route decision: Article 3 requirement group, standards basis, Annex II, Annex III, or Annex IV selection, decision owner, date, and release approval.
  • Annex III file: notified body name and number, written declaration that the same application was not lodged with another notified body, submitted technical documentation, supporting evidence, EU-type examination certificate, annexes, additions, and modification approvals.
  • Annex IV file: quality-system documentation, approved design and production controls, notified-body decision, surveillance audit reports, visit reports, test reports where performed, and approved changes.
  • CE-number check: include the notified body's identification number with the CE marking only where Annex IV is applied.
  • Retention check: keep the EU-type examination certificate, additions, technical documentation, EU declaration, and quality-system records required by the selected route for the RED retention period.
Recommended next step

Review your RED technical file before release

Use Sorena to check RED scope, Article 3 requirement mapping, Article 17 route selection, standards coverage, notified-body records, technical documentation, EU declaration, CE marking, cybersecurity, and common-charger release evidence.

Section 4

Annex V technical documentation and EU declaration fields

The technical documentation section should mirror Annex V so a reviewer can assess conformity without reconstructing the project history. Include the product description, photographs or illustrations, marking and internal layout, software or firmware versions affecting compliance, user information, installation instructions, drawings, explanations, standards mapping, alternative technical specifications, calculations, examinations, and test reports.

The EU declaration section should mirror Annex VI and identify the radio equipment type, manufacturer, object of the declaration, relevant Union harmonisation legislation, standards or technical specifications, notified-body intervention where applicable, accessories, components, software, signing details, and the place and date of issue. Add a control for keeping the declaration continuously updated and for supplying the required Member State language versions.

  • Technical file index: product description, external photos, marking artwork, internal layout, block diagram, schematics, PCB or wiring drawings, mechanical drawings, bill of materials, and operating description.
  • Compliance evidence: Article 3 matrix, risk analysis, standards matrix, test plan, test reports, design calculations, cybersecurity evidence, common-charger evidence where applicable, and nonconformity closure records.
  • Article 10 documentation: instructions, safety information, frequency bands, maximum transmitted power, language coverage, restrictions on putting into service or authorisation requirements, packaging information, and user-facing DoC or simplified DoC information.
  • EU declaration fields: declaration number if used, radio equipment type, manufacturer address, sole responsibility statement, Directive 2014/53/EU and other applicable Union acts, standards or specifications, notified-body intervention, accessories and software, signer, function, place, date, and signature.
  • Authority-readiness fields: file owner, storage location, version history, release approval, and process for making the EU declaration or technical documentation available to market surveillance authorities.
Section 5

Cybersecurity and common-charger template fields

Add a dedicated section for Article 3(3)(d), (e), and (f) cybersecurity only when the delegated requirements apply to the radio equipment category or class. The template should record whether the equipment is internet-connected, whether it processes personal data, traffic data, or location data, whether it is a toy, childcare, or wearable radio product, and whether it enables transfer of money, monetary value, or virtual currency.

Add a common-charger section where the radio equipment is in a covered Annex Ia category and can be recharged by wired charging. The record should capture USB-C charging-port evidence, charger-unbundling presentation, consumer information, label artwork, and pictogram artwork. Where charging exceeds 5 V, 3 A, or 15 W, also capture USB Power Delivery evidence and show that any additional charging protocol preserves its full functionality.

  • Cybersecurity applicability: internet-connected status, data categories processed, toy, childcare, wearable, payment or virtual-currency functionality, exclusions considered, Article 3(3)(d), (e), and (f) decision, evidence owner, and application-date note.
  • Cybersecurity evidence: threat model, network-protection controls, personal-data and privacy controls, fraud-protection controls, authentication, update handling, secure configuration, test evidence, and residual-risk approval.
  • Common-charger applicability: Annex Ia device category, applicable date, wired charging capability, USB-C port and cable evidence, charging voltage, current and power, USB Power Delivery evidence where the trigger is exceeded, charger-included or charger-not-included decision, and online or distance-selling display checks.
  • Common-charger consumer information: charging-capability specifications, compatible charging devices, minimum and maximum power values for the label, USB Power Delivery indication where supported, instructions, packaging, and pictogram or label artwork.
  • Release blocker: do not close the template while an applicable delegated cybersecurity requirement, common-charger information field, DoC field, CE marking issue, or notified-body route decision remains unresolved.
Section 6

CE marking, release approval, and change triggers

The release section should confirm that conformity has been demonstrated, the technical documentation is complete, the EU declaration has been drawn up, and the CE marking is applied correctly before market placement. The record should also show that instructions, safety information, labels, restrictions, packaging information, and user-facing DoC information are aligned with the assessed radio equipment type.

Reopen the template whenever a change could affect the Article 3 matrix, the Article 17 route, the standards basis, the technical documentation, or the release evidence. RED-sensitive changes include antenna changes, radio parameter changes, firmware changes, cybersecurity feature changes, charging changes, accessory changes, supplier changes, production changes, standard updates, and authority feedback.

  • CE marking record: artwork, location on equipment or data plate, packaging visibility, legibility, indelibility, application before market placement, and Annex IV notified-body number where relevant.
  • Accompanying information record: instructions and safety information, frequency bands, maximum transmitted power, Article 10(10) restrictions, label or pictogram where required, and simplified DoC internet address where used.
  • Production-control record: manufacturing process controls, configuration lock, incoming inspection for radio-critical components, final test checks, sample testing where risk warrants it, complaint register, nonconforming equipment register, recall records, and distributor communication.
  • Formal non-compliance screen: missing or wrongly affixed CE marking, missing or incorrect EU declaration, incomplete technical documentation, incorrect notified-body identification number, missing Article 10 information, or incorrect common-charger pictogram or label.
  • Change trigger log: design, antenna, radio module, firmware, software, cybersecurity, charger, accessory, supplier, production, intended use, market, standard, delegated act, incident, complaint, nonconformity, recall, or authority request.
Primary sources

References and citations

eur-lex.europa.eu
Referenced sections
  • Supports manufacturer obligations, CE marking, instructions, traceability, production conformity, formal non-compliance examples, and market-surveillance evidence expectations.
"technical documentation is either not available or not complete"
single-market-economy.ec.europa.eu
Referenced sections
  • Supports the role of notified bodies and manufacturer choice of legally designated bodies for conformity-assessment tasks.
"Manufacturers are free to choose"
single-market-economy.ec.europa.eu
Referenced sections
  • Commission source for RED implementation context and guidance links.
"Radio Equipment Directive"
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