RED technical file and Declaration of Conformity

Author Hugues Orgitello Last updated 25 May 2026

RED · Pillar

The RED technical file follows the generic structure of any CE file but adds several specific contents required by Annex V, extended risk analysis, description of radio configurations, SDR documentation, cybersecurity evidence since 2025. This page details the requirements specific to RED in complement to the CE technical file.

RED-specific content (Annex V)

In addition to elements common to all CE directives (description, drawings, standards, tests, DoC), RED Annex V adds:

A description of accessories and components, including software, that enable the radio equipment to operate in conformity with essential requirements.
A complete description of authorised hardware-software combinations for SDR equipment.
The risk analysis specific to article 3.1(a) safety and article 3.3 cybersecurity when activated.
The description of tested and authorised radio configurations (powers, modulations, antennas, bands).
Test reports per applied harmonised standard.
Justifications when a standard is not fully applied.

Typical RED file structure

/RED-technical-file
  /00-doc                       (signed DoC)
  /01-identification             (description, brand, type, photos, models)
  /02-architecture
    /functional-block-diagram
    /radio-description           (bands, modulations, protocols)
    /cybersecurity-architecture  (since 2025, if 3.3 applicable)
  /03-design
    /electrical-schematics
    /mechanical-drawings
    /pcb-gerbers
    /bom
  /04-radio-modules
    /module-datasheets           (Wi-Fi, BLE, cellular, etc.)
    /module-CE-certificates
    /integration-guides          (from module manufacturer)
  /05-antennas
    /antenna-datasheets
    /radiation-patterns
    /impedance-tests
  /06-risk-analyses
    /3-1a-safety                 (SAR or exposure calculation)
    /3-1b-emc                    (compatibility)
    /3-3-cybersecurity           (since 2025)
  /07-standards-applied           (exact list with ETSI versions)
  /08-tests
    /internal-pre-tests
    /external-lab-reports
      /article-3-1a-sar
      /article-3-1b-emc
      /article-3-2-spectrum
      /article-3-3-cybersecurity
  /09-radio-configurations        (power/modulation/band/antenna table)
  /10-sdr-software-defined        (if applicable)
    /hardware-firmware-matrix
    /configuration-protections
    /update-procedure
  /11-critical-components
  /12-rohs-reach
  /13-user-documentation          (translated manual, simplified DoC)
  /14-modifications               (history, impacts)

Radio configurations description (Annex V)

Annex V requires a precise description of authorised radio configurations. For a multi-band / multi-modulation product, the file must present a table such as:

Band	Modulation	Max power	Antenna used	Applied standard
2.4 GHz Wi-Fi	OFDM 802.11n	18 dBm conducted, 20 dBm EIRP	Integrated PCB ant., 2 dBi gain	EN 300 328 V2.2.2
2.4 GHz BLE	GFSK	8 dBm conducted, 10 dBm EIRP	Integrated PCB ant.	EN 300 328 V2.2.2
868 MHz LoRa	LoRa SF7-SF12	14 dBm conducted, 14 dBm EIRP	External SMA ant., 0 dBi gain	EN 300 220 V3.2.1
GPS L1	Receive only	n/a	Passive patch antenna	EN 303 413 V1.2.1

This table is the most consulted element in audit, it summarises radio compliance at a glance.

SDR documentation

For software-defined equipment, the file must contain:

Hardware-firmware matrix

Exhaustive list of authorised hardware and firmware version combinations:

HW reference	FW min version	FW max version	Activated bands	Status
SP-CT-100-A	1.0.0	1.4.x	EU868 G3 + Wi-Fi 2.4	Production
SP-CT-100-A	2.0.0	2.x.x	EU868 G3 + Wi-Fi 2.4 + BLE	Production
SP-CT-100-B	2.0.0	2.x.x	EU868 G1-G4 + Wi-Fi 2.4 + BLE	Production
SP-CT-100-A	0.x.x	,	All	Pre-production (not marketed)

Protection mechanisms

Description of mechanisms that prevent the end user from installing an unauthorised configuration:

Firmware signature by the manufacturer (ECDSA, RSA keys, or equivalent)
Boot-time verification of the signature
Lock-down of bands not authorised in the region of use
Anti-rollback mechanisms to vulnerable versions

Update procedure

Distribution channel (OTA or USB, signed)
Integrity verification before flash
Automatic rollback on failure
Update logs

RED critical components

For RED, critical components to document include:

Component	Expected documentation
Radio module	Datasheet, CE certificate, integration guide, RoHS declaration
Antenna	Datasheet (gain, impedance, patterns), if not supplied with module
Crystal/oscillator	Datasheet, tolerance, thermal stability
RF filter	Datasheet, out-of-band attenuation
RF amplifier	Datasheet, compression point, linearity
RF connectors	Datasheet, impedance, VSWR

For a commercial radio module, the manufacturer's integration guide is a central document, it indicates the conditions to respect so that the module CE marking remains valid once integrated. If these conditions are not reproduced in the final product, the module's marking no longer covers the product (see Common pitfalls).

The RED Declaration of Conformity

The RED DoC follows the general structure of article 18 + Annex VI, with some specificities:

Explicit reference to directive 2014/53/EU (not the old 1999/5/EC).
Citation of all harmonised standards applied (safety, EMC, spectrum, cybersecurity).
Mention of frequencies and powers for multi-band products.

Annotated example

              EU DECLARATION OF CONFORMITY (RED)
                     No DoC-RED-2026-001

We, [COMPANY NAME], located at [ADDRESS], declare under our sole
responsibility that the product:

    Designation:  Connected temperature sensor
    Model:        SP-CT-100
    Type / ref:   SP-CT-100-WB

is in conformity with directive 2014/53/EU.

Operated frequency bands and maximum power (EIRP):

    Wi-Fi 2.4 GHz (2400-2483.5 MHz): 20 dBm
    BLE 2.4 GHz (2400-2483.5 MHz): 10 dBm
    LoRa 868 MHz (868-868.6 MHz): 14 dBm

The following harmonised standards have been applied:

    EN 62311:2020                   (article 3.1(a))
    EN 301 489-1 V2.2.3 (2019-11)   (article 3.1(b))
    EN 301 489-17 V3.2.4 (2020-09)  (article 3.1(b))
    EN 300 328 V2.2.2 (2019-07)     (article 3.2 — Wi-Fi/BLE)
    EN 300 220 V3.2.1 (2018-06)     (article 3.2 — LoRa)
    EN 18031-1:2024                 (article 3.3(d))
    EN 18031-2:2024                 (article 3.3(e))
    EN 62368-1:2020/A11:2020        (LVD via 3.1(a))

Signed for and on behalf of:  [COMPANY NAME]
                              [CITY], [DATE]

[NAME]
[POSITION]
[Signature]

Simplified DoC per Article 10(9)

RED Article 10(9) allows including a simplified DoC in the user manual. Typical format:

The undersigned, [COMPANY NAME], declares that the radio equipment
type SP-CT-100 is in conformity with directive 2014/53/EU.

The full text of the EU declaration of conformity is available
at the following internet address:
https://www.example.com/doc/SP-CT-100

This simplified DoC must point to a stable, publicly accessible URL where the full DoC is downloadable without registration. Recommended practice:

Permanent URL (no temporary parameters)
PDF/A format
Accessible without cookies or login
Included in printed manual AND digital manual
Maintenance for 10 years after last unit

Retention and archival

As for all CE directives, retention is 10 years after placing on the market of the last unit. For RED, specific points:

Firmware archive in all distributed versions (not just the latest)
Update logs for SDRs (if applicable)
Cybersecurity documentation: risk analyses, evaluation reports, vulnerability management plans
Radio configurations history per product version

Sources & references

Annex V of Directive 2014/53/EU , EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
Article 10 of RED, simplified DoC , EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj