RED technical file and EU declaration of conformity

Hugues Orgitello updated 7 Oct 2026 16 min read

Article 21 of Directive 2014/53/EU says the technical documentation must contain "all relevant data or details of the means used" to meet the essential requirements, and "at least" the nine elements of Annex V. Those nine elements are shorter and more precise than most templates suggest: no SDR matrix, no mandatory radio configuration table, no cybersecurity chapter by name. What makes a RED file heavier than a CE technical file under other directives comes from elsewhere in the text: the assessment "in all possible configurations" of Article 17(1), the DoC of Annex VI, and since 1 August 2025 the evidence for articles 3(3)(d), (e) and (f). This page reads each provision as published, with the Commission RED Guide where it interprets them, as of 7 October 2026.

TL;DR:

Annex V lists nine elements, (a) to (i). Element (i), the explanation of Article 10(2) and 10(10), is specific to RED and the one most often missing.
The file must exist before placing on the market and be "continuously updated" (Article 21(2)). The RED Guide reads this as the whole history: every DoC, test report and risk assessment, not only the latest.
Retention is 10 years after the equipment is placed on the market (Article 10(4)); the RED Guide counts from the last unit of the product model.
The full DoC follows the nine points of Annex VI; the simplified DoC uses the Annex VII wording and must give the exact internet address of the full text (Article 10(9)).
EN 301 489-1 is not a cited harmonised standard. For a Wi-Fi or BLE radio the DoC cites EN 301 489-17 V3.3.1 (Decision (EU) 2025/893), whose two notices the test report has to respect.
Article 3(3)(d), (e), (f) evidence is required for equipment placed on the market from 1 August 2025 to 10 December 2027. Delegated Regulation (EU) 2026/339 repeals Delegated Regulation 2022/30 from 11 December 2027, when the Cyber Resilience Act applies in full.

What Annex V requires, element by element

Annex V opens with "The technical documentation shall, wherever applicable, contain at least the following elements". The table gives each element, the RED Guide reading where there is one, and what usually fills it.

Annex V	Text of the directive	What the RED Guide adds	Typical content
(a)(i)	Photographs or illustrations showing external features, marking and internal layout		External and internal photos, label artwork with the CE marking
(a)(ii)	Versions of software or firmware affecting compliance with essential requirements	Only where the software has an influence on conformity, "such as a change of software that would allow operation in a different frequency range or at higher output power"	Firmware versions tested, and the versions released since with their impact assessment
(a)(iii)	User information and installation instructions	The information referred to in Article 10(8)	Manual with frequency bands and maximum power, accessories and software, restrictions of use
(b)	Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits		Schematics, PCB layout, mechanical drawings, bill of materials
(c)	Descriptions and explanations needed to understand those drawings and the operation		Block diagram, radio architecture, antenna description
(d)	List of harmonised standards applied in full or in part; where not applied, the solutions adopted and the other technical specifications; for partly applied standards, the parts applied	A standard not cited in the OJ must be justified; a test report to an older version needs a documented delta analysis, and a delta that is a deviation under article 3.2 or 3.3 requires a Notified Body	Standards table with versions, restrictions and the parts applied
(e)	Copy of the EU declaration of conformity		Every signed DoC issued for the type
(f)	Where Annex III has been applied, copy of the EU-type examination certificate and its annexes		Notified Body certificate and its additions
(g)	Results of design calculations, examinations carried out		RF exposure assessment, link budget, design reviews
(h)	Test reports		Laboratory reports per standard and per radio
(i)	Explanation of compliance with Article 10(2) and of the inclusion or not of information on the packaging under Article 10(10)	For example a statement listing the countries where the equipment may be operated and the national radio interfaces, and either "no restrictions of use" or a pointer to the packaging and manual	One-page statement per product

Three further obligations sit outside Annex V but end up in the same file:

Risk analysis. Annex III point 3(c) asks for "an adequate analysis and assessment of the risk(s)". The RED Guide states that the technical documentation must include it "independently of the CAP applied", so for module A too.
Configurations. Article 17(1): "Where the radio equipment is capable of taking different configurations, the conformity assessment shall confirm whether the radio equipment meets the essential requirements set out in Article 3 in all possible configurations." For multimode equipment, the RED Guide limits the assessment to the modes that may legally be operated in EU, EEA and EFTA countries.
Language. For an EU-type examination, Article 21(3) requires an official language of the Member State of the Notified Body or a language that body accepts. On a reasoned request, Article 10(12) requires documentation "in a language which can be easily understood by that authority".

If the file falls short, Article 21(4) lets the market surveillance authority ask the manufacturer or importer to have a test performed, at their expense, by a body acceptable to the authority.

Which conformity route the file supports (Article 17)

Essential requirement	Harmonised standards cited in the OJ, applied in full	Not applied, applied in part, or none exist
3(1)(a) health and safety, 3(1)(b) EMC	Annex II (module A), Annex III (modules B + C) or Annex IV (module H)	Same three choices (Article 17(2))
3(2) spectrum, 3(3) specific requirements	Annex II, III or IV (Article 17(3))	Annex III or IV only, with a Notified Body (Article 17(4))

Under Annex III, the EU-type examination is done "through examination of the technical documentation and supporting evidence (...) without examination of a specimen". The notified body works on the file. Detailed steps are in the RED procedure.

A working folder structure

The directive does not prescribe any structure. This layout simply maps one folder to each Annex V element and to the obligations listed above.

/RED-technical-file
  /00-doc                        Annex V(e): every signed DoC, current and previous
  /01-description                Annex V(a)(i): photos, label, marking
  /02-software                   Annex V(a)(ii): firmware versions affecting compliance
  /03-user-information           Annex V(a)(iii): manual, Article 10(8) and 10(10) content
  /04-design                     Annex V(b) and (c): schematics, layout, BOM, explanations
  /05-standards                  Annex V(d): standards with versions, parts applied, justifications
  /06-risk-assessment            Annex III point 3(c): 3(1)(a), 3(1)(b), 3(2), 3(3) as applicable
  /07-configurations             Article 17(1): every configuration and how it was assessed
  /08-calculations               Annex V(g): RF exposure, design calculations
  /09-test-reports               Annex V(h): one subfolder per standard and radio
  /10-notified-body              Annex V(f): EU-type examination certificate and additions
  /11-article-10-2-and-10-10     Annex V(i): where the equipment may be operated, restrictions
  /12-reused-assessments         Radio module assessments relied upon
  /13-changes                    Article 10(5): design changes and standard revisions, with impact

Radio configurations (Article 17(1))

Annex V does not ask for a configuration table, but Article 17(1) requires the assessment to cover every configuration, and a table is the clearest way to show that it did. A template:

Radio	Band	Modulation or mode	Maximum power declared	Antenna	Article 3(2) standard	Article 3(1)(b) standard
Wi-Fi	2 400 to 2 483.5 MHz	[modes]	[value, EIRP]	[type, gain]	EN 300 328 V2.2.2	EN 301 489-17 V3.3.1
BLE	2 400 to 2 483.5 MHz	[modes]	[value, EIRP]	[type, gain]	EN 300 328 V2.2.2	EN 301 489-17 V3.3.1
Sub-GHz SRD	[sub-band]	[modes]	[value, e.r.p.]	[type, gain]	EN 300 220-2 V3.3.1	EN 301 489-3 V2.3.2
GNSS receiver	[band]	Receive only	Not applicable	[type]	EN 303 413 V1.2.1	EN 301 489-19 V2.2.1

The standard versions are those in Annex I to Implementing Decision (EU) 2022/2191 as amended; EN 300 220-2 V3.1.1 also keeps its citation until 11 June 2027. Each EN 301 489 part listed carries two notices: no presumption for emissions below 9 kHz, and no presumption for article 3(1)(b) if its clause 6 is applied. Full list and dates: RED harmonised standards. The power you declare must match what Article 10(8) puts in the manual: the frequency bands and the "maximum radio-frequency power transmitted" in each.

Software, SDR and updates

Two provisions of the directive aimed at software-defined radio (SDR) are not active. Article 4 (information on combinations of radio equipment and software) and article 3(3)(i) (software loaded only where the combination has been shown compliant) both depend on a delegated act, and the RED Guide states for each: "currently no delegated act". No SDR-specific annex exists in the technical file today.

What does apply to software:

Annex V(a)(ii): the versions of software or firmware affecting compliance.
Article 10(8) and Annex VI point 8: a description of accessories and components, including software, "which allow the radio equipment to operate as intended". The RED Guide limits point 8 of the DoC to items that (1) influence conformity and (2) are intended to be installed or changed by the user without the control of the manufacturer.
Updates: whether delivered OTA or locally, the RED Guide treats a software update as maintenance unless it "modifies the original intended functions, radio interface, type or performance of the product and this was not foreseen in the initial risk assessment", or changes the nature of the hazard or increases the level of risk. In those cases, the updated product is treated as a new product.
SDR in general: the RED Guide asks SDR manufacturers to take "special care" with Article 10(8), Article 10(10) and Annex VI point 8.

A hardware and firmware matrix (hardware reference, firmware range, bands enabled, assessment that covers it) is a practical way to answer (a)(ii) for a product with several firmware lines, and to show the market surveillance authority which units a given DoC covers. Signed firmware and band locking are design measures; the directive does not list them, but if user-changeable software could take the equipment out of its assessed configurations, the risk assessment has to address it. Since 1 August 2025, EN 18031-1 also deals with update mechanisms for internet-connected equipment.

Radio modules and reused assessments

The RED Guide treats RF modules placed on the market on their own as radio equipment: their manufacturer must assess the risks identifiable before integration and "provide instructions which, if followed, will ensure that they remain compliant". This is "without prejudice to any new obligations that might arise" when the module is integrated.

For the host product, the RED Guide is explicit: the manufacturer "may use assessments performed previously for components or parts", remains "responsible for the conformity of the whole product", and "the reused assessment of the components or parts may not be sufficient". Those reused assessments must be included in the technical file. The module integration guide is therefore an input to the risk assessment of the host, not a substitute for it (see Common pitfalls).

Documentation commonly kept for the radio parts:

Component	Documentation to keep
Radio module	Datasheet, DoC of the module, test reports relied upon, integration instructions, RoHS declaration
Antenna	Datasheet (gain, impedance, patterns), unless covered by the module assessment
Crystal or oscillator	Datasheet, frequency tolerance, temperature stability
RF filter, amplifier, connectors	Datasheets with the parameters the radio tests depend on

The EU declaration of conformity, point by point (Annex VI)

Article 18 requires the DoC to follow the model structure of Annex VI, to be "continuously updated" and to be translated into the language required by each Member State where the equipment is placed or made available. Where several Union acts apply, Article 18(3) requires a single DoC covering all of them, with their publication references.

Annex VI point	What it must contain	Notes from the text and the RED Guide
Number	Optional	Footnote to Annex VI: assigning a number is optional
1	Radio equipment (product, type, batch or serial number)	Must link the product, the full DoC and the technical file
2	Name and address of the manufacturer or the authorised representative
3	"This declaration of conformity is issued under the sole responsibility of the manufacturer."	Only the manufacturer or the authorised representative signs; a laboratory report or a Notified Body certificate is not a DoC
4	Object of the declaration, allowing traceability	May include a colour image where necessary for identification
5	Directive 2014/53/EU and other Union harmonisation legislation where applicable	Directive 2013/35/EU (workers and EMF) is not product legislation and does not belong here
6	References of harmonised standards or other technical specifications, "with their identification number and version and, where applicable, date of issue"	The RED Guide recommends the format of the OJ list
7	Where applicable, the Notified Body (name, number), what it performed, and the certificate	The module or Annex and the aspects covered must be stated
8	Where applicable, accessories and components, including software, covered by the DoC	Only items that influence conformity and that the user can install or change
9	Additional information, signature, place and date

Annotated example

Placeholders in brackets. The standards are the cited versions on 7 October 2026 for a product with Wi-Fi, BLE and an 868 MHz SRD radio.

                 EU DECLARATION OF CONFORMITY
                 (number optional)

1. Radio equipment: [product name], type [type], serial numbers from [first serial]
2. Manufacturer: [company name], [postal address]
3. This declaration of conformity is issued under the sole
   responsibility of the manufacturer.
4. Object of the declaration: [description allowing traceability,
   hardware version, image if needed]
5. The object of the declaration described above is in conformity
   with the relevant Union harmonisation legislation:
   Directive 2014/53/EU
   [Directive 2011/65/EU and other acts that apply]
6. References to the harmonised standards used and to the other
   technical specifications in relation to which conformity is declared:
   Article 3(1)(a): [RF exposure and electrical safety references
                     applied, with version; see note below]
   Article 3(1)(b): EN 301 489-17 V3.3.1
                    EN 301 489-3 V2.3.2
   Article 3(2):    EN 300 328 V2.2.2
                    EN 300 220-2 V3.3.1
   Article 3(3)(d): EN 18031-1:2024
   Article 3(3)(e): EN 18031-2:2024 (if personal data are processed)
7. Notified body: [not applicable, or name, number, module, aspects
   covered, certificate number]
8. Accessories and software covered: [only those that influence
   conformity and can be changed by the user, for example the
   antenna types allowed]
9. Additional information: [optional, for example frequency bands
   and maximum power]

Signed for and on behalf of: [company name]
[place and date of issue]
[name, function] [signature]

Note on article 3(1)(a): the RED list (Annex I to Decision 2022/2191) cites only EN 50360, EN 50385, EN 50401 and EN 50566 for this requirement. EN 62311, EN 62479 and EN 62368-1 are not in it; when used, they are listed in point 6 as "other technical specifications" and justified in the file under Annex V(d). Note on article 3(1)(b): EN 301 489-1 is not cited on its own; it enters through the specific parts.

The simplified declaration (Article 10(9) and Annex VII)

Article 10(9) requires each item of radio equipment to be accompanied by either a copy of the DoC or a simplified DoC. The RED Guide adds that at least one of them must be in printed form, and that it can sit in the manual, on a separate sheet, on the product or on the packaging. The Annex VII wording is:

Hereby, [Name of manufacturer] declares that the radio equipment type
[designation of type of radio equipment] is in compliance with
Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the
following internet address: [exact internet address]

What the texts require of it:

Exact internet address of the full text (Article 10(9)). The RED Guide accepts an address that leads to a page where the manufacturer maintains its DoCs, provided the right one is simple to identify.
Translation into the language required by the Member State, both for the simplified DoC and for the full text online (Article 18(2)).
All legislation in the full DoC. The simplified DoC may name RED only, but the full DoC online must cover every applicable act.
Old and new versions online. When the assessment changes, for example after a new version of a standard, a new DoC is issued for new units and the RED Guide asks for both to remain available online.

The directive sets no file format, no login rule and no hosting period for the web page. Keeping it reachable for as long as the 10-year retention runs is the simplest way to stay consistent with Article 10(4).

Retention and who keeps what

Who	What	How long	Source
Manufacturer	Technical documentation and DoC	10 years after the equipment has been placed on the market	Article 10(4); Annex II point 4.2
Manufacturer (module B + C)	EU-type examination certificate, annexes and additions, with the file	10 years	Annex III, module B point 9
Manufacturer (module H)	File, quality system documentation, approved changes, Notified Body decisions and reports	10 years	Annex IV point 6
Authorised representative	DoC and technical documentation at the disposal of the authorities	10 years	Article 11(2)(a)
Importer	Copy of the DoC; ensure the file can be made available on request	10 years	Article 12(8)
Notified Body (module B)	Copy of the certificate and the technical file	10 years after assessment or until the certificate expires	Annex III, module B point 8
Every economic operator	Who supplied them and whom they supplied	10 years	Article 15

The RED Guide counts the manufacturer period from "the last unit of the product model placed on the EU market". It also states that there is "no obligation to keep it inside the Union", provided the file can be presented on request. Delegated Regulation (EU) 2026/339 (recital 5) keeps market surveillance of articles 3(3)(d), (e) and (f) for equipment placed on the market between 1 August 2025 and 10 December 2027, so the cybersecurity part of the file has to be kept for the full period even after the repeal.

Dated changes that affect the file

Date	Act	Effect on the file or the DoC
13 June 2016	Directive 2014/53/EU	RED applies; DoCs reference 2014/53/EU
21 July 2017	Implementing Regulation (EU) 2017/1354 (OJ L 190)	Format of the Article 10(10) packaging information: short statement or pictogram
10 November 2022	Implementing Decision (EU) 2022/2191 (OJ L 289)	Single list of cited standards, amended since
28 December 2024	Directive (EU) 2022/2380	Common charger requirements (Article 3(4)) and Article 10(8) labelling for the listed categories; laptops from 28 April 2026
30 January 2025	Implementing Decision (EU) 2025/138 (adopted 28 January 2025, published in the OJ and in force 30 January 2025)	EN 18031-1, -2 and -3:2024 cited with restrictions
15 May 2025	Implementing Decision (EU) 2025/893	EN 301 489-17 V3.3.1 and EN 301 489-3 V2.3.2 cited, with the 9 kHz and clause 6 notices
1 August 2025	Delegated Regulation (EU) 2022/30 (as amended by 2023/2444)	Articles 3(3)(d), (e), (f) apply to the categories it lists
15 November 2026	Implementing Decision (EU) 2025/893	EN 301 489-52 V1.2.1 (cellular user equipment EMC) loses its citation
11 June 2027	Implementing Decision (EU) 2025/2499	EN 300 220-2 V3.1.1 loses its citation
11 December 2027	Delegated Regulation (EU) 2026/339	Delegated Regulation 2022/30 repealed; cybersecurity moves to the Cyber Resilience Act

A withdrawn reference does not make units already on the market non-compliant, but Article 10(5) requires changes in the harmonised standards to be "adequately taken into account" for series production. The RED Guide says reassessment does not mean redoing every test; the manufacturer reviews the risk assessment, and the analysis goes into the file.

Claims the texts contradict

Common claim	What the text says
"Annex V requires a description of the hardware and software combinations of SDR equipment."	Annex V has nine elements, (a) to (i), none of them specific to SDR. Article 4 on combinations of radio equipment and software needs a delegated act, and the RED Guide states there is none.
"Annex V requires a radio configuration table."	Annex V does not mention configurations. Article 17(1) requires the assessment to cover "all possible configurations"; a table is a convenient way to show it.
"Annex V requires a description of accessories and components, including software."	That wording is in Article 10(8) (instructions) and Annex VI point 8 (DoC), not in Annex V.
"EN 301 489-1 V2.2.3 is a harmonised standard to cite in the DoC."	It is not in Annex I to Decision 2022/2191. The cited parts are the specific ones, for example EN 301 489-17 V3.3.1.
"EN 301 489-17 V3.2.4 is the current version."	Decision 2025/893 cites V3.3.1, with two notices: nothing below 9 kHz, and no presumption if clause 6 is applied.
"EN 62311 and EN 62368-1:2020/A11:2020 give presumption under article 3(1)(a)."	Neither is in the RED list. They can only appear as other technical specifications. Under the LVD, the cited edition of EN 62368-1 is EN 62368-1:2014 + AC:2015.
"EN 300 220 V3.2.1 is the 868 MHz standard to cite."	The cited references are EN 300 220-2 V3.3.1, and V3.1.1 until 11 June 2027.
"The DoC must state frequency bands and maximum power."	Annex VI does not require it. Article 10(8) puts that information in the instructions; it may be repeated under point 9.
"If the module integration conditions are not reproduced, the module CE marking no longer covers the product."	The host manufacturer is always responsible for the whole product. Module assessments may be reused, "may not be sufficient", and must be included in the file (RED Guide).
"Under module B the Notified Body tests a sample."	Annex III point 2: EU-type examination is carried out on the technical documentation and supporting evidence "without examination of a specimen".
"The simplified DoC must be a PDF/A, accessible without registration, at a permanent URL."	The text requires the Annex VII wording and the exact internet address of the full DoC. Format and access rules are not in the directive.
"The technical file must be stored in the EU."	The RED Guide: "there is no obligation to keep it inside the Union", provided it can be made available.
"The cybersecurity section is a permanent part of the RED file."	Delegated Regulation 2022/30 is repealed from 11 December 2027 by 2026/339; equipment placed from 1 August 2025 to 10 December 2027 stays subject to market surveillance on those points.