Technical file and Declaration of Conformity: differences

Hugues Orgitello updated 7 Oct 2026 16 min read

The technical documentation is the manufacturer's evidence: Decision 768/2008/EC requires it to "make it possible to assess the product's conformity" and to include "an adequate analysis and assessment of the risk(s)". The EU declaration of conformity is the signed statement built on that evidence, by which the manufacturer "shall assume responsibility for the compliance of the product". Both are kept for 10 years. This page reads the module A text, the annex of each CE act and the Blue Guide 2022, as of 7 October 2026.

TL;DR:

• The common list comes from module A (Decision 768/2008/EC, Annex II, point 2): description, drawings, explanations, standards applied, calculations and examinations, test reports, plus the risk analysis. Each act then adds its own items: RED asks for a copy of the DoC and firmware versions, the EMC Directive an EMC assessment, the Machinery Regulation the instructions and, on request, safety software source code.
• Retention is 10 years after placing on the market for EMC, LVD, RED and RoHS, "at least 10 years" for machinery. The Blue Guide counts it per individual product, so from the last unit.
• The DoC number is optional. Point 1 identifies the product, not the declaration; the standards in point 6 need their version or date.
• The authorised representative may sign the DoC if the mandate says so, but may not draw up the technical documentation (Article R3(1)). A non-EU signatory is allowed.
• One product, one DoC: where several acts require a declaration, a single DoC covers all of them, with their publication references.

What is the difference between the technical file and the DoC?

The two documents are inseparable but do different jobs: the file is the proof, the DoC is the claim built on that proof. The EU Declaration of Conformity guide covers the DoC in depth; the technical documentation contents guide walks the file item by item.

	Technical documentation	EU declaration of conformity
Legal basis	Decision 768/2008/EC Annex II (module A point 2) and the annex of each act	Article R10 and Annex III of Decision 768/2008/EC, and the model annexed to each act
Purpose	Make it possible to assess conformity, including the risk analysis	State that the requirements are met; by drawing it up the manufacturer assumes responsibility
Who draws it up	The manufacturer only: it "shall not form part of the authorised representative's mandate" (Article R3(1))	The manufacturer, or the authorised representative if the mandate covers it (module A point 5)
Who sees it	Market surveillance authorities, on reasoned request; a notified body when one is involved	Authorities on request; it also accompanies the product for radio equipment, machinery and the other acts listed in Blue Guide section 4.4
Retention	10 years after placing on the market (at least 10 years for machinery)	Same period, kept together with the file
Language	Supplied "in a language which can be easily understood by that authority" (Article R2(9))	Translated into the language or languages required by the Member State where the product is placed or made available (Article R10(2))
Updates	Must reflect all versions of the product (Blue Guide 4.3)	"Continuously updated"; a new version for products placed after a change (Blue Guide 4.4)

What the technical documentation must contain, act by act

Module A gives the base list. Each sectoral act restates it in its own annex and adds items. The table below reads the texts as published; an empty cell means the item is not named in that annex, not that it is useless.

Element	Module A, Decision 768/2008	EMC 2014/30/EU, Annex II pt 3	LVD 2014/35/EU, Annex III pt 2	RED 2014/53/EU, Annex V	Machinery Reg. 2023/1230, Annex IV Part A
Adequate analysis and assessment of the risk(s)	Point 2, opening paragraph	Opening paragraph	Opening paragraph	Not in Annex V; Annex III pt 3(c), and the RED Guide asks for it under every module	(b): risk assessment, applicable requirements, protective measures, residual risks
General description	Yes	(a)	(a)	(a), with photos, marking and internal layout	(a), "complete description" and intended use
Design and manufacturing drawings, schemes of components, sub-assemblies, circuits	Yes	(b)	(b)	(b)	(c)
Descriptions and explanations of those drawings and of the operation	Yes	(c)	(c)	(c)	(d)
Harmonised standards applied, parts applied, other solutions where not applied	Yes	(d)	(d), also international or national standards of Articles 13 and 14	(d)	(e) and (f), including common specifications
Design calculations, examinations	Yes	(e)	(e)	(g)	(g)
Test reports	Yes	(f)	(f)	(h)	(g)
Specific assessment		EMC assessment of all normal intended operating conditions and representative configurations (point 2)		Article 10(2) and 10(10) explanation (i); all possible configurations (Article 17(1))	Results of tests on safe assembly and putting into service (o)
Copy of the DoC				(e)	(k): DoCs of incorporated products, where appropriate
Instructions				(a)(iii): user information and installation instructions	(i): instructions and Annex III section 1.7.4 information
Software				(a)(ii): software or firmware versions affecting compliance	(m): source code or programming logic of safety software, on reasoned request; (n): sensor-fed and autonomous machinery
Production	Point 3 obligation (no document named)	Point 4 obligation	Point 3 obligation	Annex II point 3 obligation	(h) production means; (l) internal measures for series production
Notified body certificate				(f), where Annex III is used	Depends on the procedure

Three points the table makes visible:

• A copy of the signed DoC is not a common element. Module A, the EMC Directive and the LVD do not list it in the file; they require the DoC to be kept "together with the technical documentation". RED Annex V(e) does list it.
• The risk analysis is not an LVD speciality. The same sentence opens module A, the EMC annex and the LVD annex. The Blue Guide (section 4.3) explains it: identify all possible risks, determine the applicable acts and essential requirements, document the analysis and how each risk is addressed, including the requirements a partly applied standard does not cover.
• No act imposes a list of "safety-critical components". That list, and the component certificates that go with it, come from the harmonised standard applied (for example EN 62368-1 for audio, video and ICT equipment), not from the annexes.

RoHS (2011/65/EU)

Article 7(b) requires the manufacturer to "draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC". Article 7(c) adds that where another act requires a procedure at least as stringent, RoHS compliance "may be demonstrated within the context of that procedure" and "a single technical documentation may be drawn up".

The harmonised standard is EN IEC 63000:2018, "Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances", cited by Implementing Decision (EU) 2020/659 (OJ L 155, 18 May 2020). It replaced EN 50581:2012, whose reference was withdrawn from 18 November 2021. A DoC dated after that should not cite EN 50581.

Machinery: two texts until 20 January 2027

Machinery Directive 2006/42/EC is repealed from 20 January 2027, the date from which Regulation (EU) 2023/1230 applies. The Regulation adds items the Directive did not name in this form: the source code or programming logic of safety-related software on reasoned request (Annex IV Part A (m)), a description for sensor-fed, remotely driven or autonomous machinery (n), and a choice for the DoC: it accompanies the machine, or the instructions give "the internet address or machine-readable code" where it can be accessed (Article 10(8)). A digital DoC must stay online "for the expected lifetime" and at least 10 years. See Machinery Directive 2006/42 and Regulation 2023/1230.

Risk analysis: what the harmonised standard adds

For audio, video, IT and communication equipment, the harmonised standard under the LVD is EN 62368-1:2014 with AC:2015 (the 2020 and 2024 EN editions are not cited under the LVD). It is a hazard-based standard: it classifies energy sources and requires safeguards between each source and a body part.

Hazard	Classes in EN 62368-1
Electrically caused injury	ES1, ES2, ES3
Electrically caused fire	PS1, PS2, PS3 (power sources), plus potential ignition sources
Mechanically caused injury	MS1, MS2, MS3
Thermal burn	TS1, TS2, TS3
Radiation	RS1, RS2, RS3

The class limits depend on frequency, current, capacitance and pulse conditions: take them from the edition you test to, not from a summary (detail on CE tests and in the IEC 62368-1 guide). For radio equipment, the RED list cites no general electrical safety standard, so EN 62368-1 is used as another technical specification under article 3(1)(a).

What the file needs from this work, per the Blue Guide: the risks identified, the acts and essential requirements that follow, how each risk is addressed, and how requirements not covered by the standards applied are dealt with. The texts set no page count and no format.

Components that act as safeguards

When a component is part of a safeguard (insulation, fire enclosure, protective device), the safety report normally relies on its own certification against the relevant component standard. Typical cases for a mains-connected electronic product:

Component	Component standard usually referenced
Transformer for a switch mode power supply	EN 61558-1 / -2-16
Optocoupler across the isolation barrier	EN 60747-5-5
X and Y capacitors	EN 60384-14
Varistor	EN 61051-2
Miniature fuse	EN 60127
Appliance inlet and connector (IEC C13/C14 type)	IEC 60320
Power cord	EN 50525
Portable lithium-ion cells and batteries	IEC 62133-2
External or OEM power supply	EN 62368-1

What usually goes in the file for each: the datasheet with its revision, the certificate or test report relied on, and the RoHS evidence for the part. The list comes from the safety standard and the test report, not from the directive; which components are safeguards depends on the design. REACH Article 33 information on candidate-list substances above 0.1 % by mass is often filed alongside, but REACH is not a CE marking act.

A working folder structure

No act prescribes a structure. This layout simply maps one folder to each element of the table above.

/technical-file
  /00-doc                    every signed DoC, current and previous
  /01-description            description, intended use, photos, marking
  /02-risk-assessment        risks identified, acts and requirements, safeguards
  /03-design
    /schematics
    /mechanical-drawings
    /pcb-layout
    /bom
  /04-explanations           block diagrams, theory of operation
  /05-standards              references with version, parts applied, other solutions
  /06-calculations           design calculations, examinations
  /07-test-reports           one subfolder per standard
  /08-components             datasheets and certificates of safeguard components
  /09-rohs                   EN IEC 63000 evidence
  /10-user-information       manual, labels, translations
  /11-production             production controls, series conformity
  /12-changes                versions of the product and their assessment
  /13-red-specific           firmware versions, Article 10(2) and 10(10), configurations

Folder 12 answers a Blue Guide requirement that templates often omit: after redesigns, "the technical documentation must reflect all versions of the product", how each version is identified and how it was assessed, so that an authority holding an older unit can find the matching evidence. Folder 10 often also holds the label artwork, including the WEEE crossed-out wheeled bin symbol, which Directive 2012/19/EU requires but which is not a CE marking requirement.

What must the EU declaration of conformity contain?

Each act annexes a DoC model that follows Annex III of Decision 768/2008/EC, with small differences that matter when you merge several acts into one declaration.

Point	Decision 768/2008 Annex III	What the sectoral models change	Blue Guide 4.4
Number	"No ... (unique identification of the product)"	EMC Annex IV, LVD Annex IV and RED Annex VI: a number for the declaration is optional (footnote)	Need not be unique to each product; product, batch, type or serial number. A number for the declaration itself may be added (footnote 227)
1 to 2	Product identification; name and address of manufacturer or authorised representative	EMC and LVD: "product, type, batch or serial number"
3	"This declaration of conformity is issued under the sole responsibility of the manufacturer"
4	Object of the declaration, allowing traceability, photograph where appropriate	EMC, LVD, RED: "colour image of sufficient clarity" where necessary	An image is left to the manufacturer unless the act requires it
5	Union harmonisation legislation complied with		With publication references when several acts apply (for example EMC Article 15(3))
6	Harmonised standards or other specifications	EMC: "including the date of the standard"; RED: identification number and version; RoHS: "where applicable"	Precise and complete: the version and/or date of each standard
7	Notified body, intervention, certificate, where applicable	LVD model has no notified body point; RED adds a point 8 for accessories and software
Signature	Signed for and on behalf of, place and date, name, function, signature		Any date after completion of the conformity assessment; the managing director or a person with delegated responsibility; signatory need not be domiciled in the EU

Two rules from the articles, identical in the EMC Directive (Article 15), the LVD (Article 15) and RED (Article 18):

• Single declaration. Where a product is subject to more than one act requiring a DoC, "a single EU declaration of conformity shall be drawn up in respect of all such Union acts", identifying each with its publication reference. The Blue Guide allows it to be "a dossier made up of relevant individual Declarations of conformity".
• Translation. Into the language or languages required by the Member State where the product is placed or made available. If another operator produces the translation, the Blue Guide asks for a copy of the original signed by the manufacturer alongside it.

Annotated example

A battery-powered Wi-Fi and BLE sensor under module A, with the cited references on 7 October 2026. Placeholders in brackets.

                EU DECLARATION OF CONFORMITY
                (number optional)

1. Product: [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
6. References to the harmonised standards used and to the other
   technical specifications in relation to which conformity is declared:
   RED article 3(1)(a): [RF exposure and electrical safety references
                         applied, with version, as other specifications]
   RED article 3(1)(b): EN 301 489-17 V3.3.1
   RED article 3(2):    EN 300 328 V2.2.2
   RED article 3(3)(d): EN 18031-1:2024
   RoHS:                EN IEC 63000:2018
7. Notified body: not applicable
8. Accessories and software covered: [only those that influence
   conformity and can be changed by the user]
9. Additional information: [optional]

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

Why it cites RED and RoHS only: RED Article 1(4) states that radio equipment "shall not be subject to Directive 2014/35/EU, except as set out in point (a) of Article 3(1)", and the EMC Directive excludes equipment covered by the radio directive (Article 2(2)(a)). Why EN 301 489-1 is not listed: it is not cited on its own in the RED list; the cited part for Wi-Fi and Bluetooth is EN 301 489-17 V3.3.1, published by Decision (EU) 2025/893 with two notices (no presumption for emissions below 9 kHz, none if its clause 6 is applied). The RED-specific points are detailed in RED technical file.

Simplified DoC (RED Article 10(9) and Annex VII)

Article 10(9) requires each item of radio equipment to be accompanied by a copy of the DoC or by a simplified DoC, which "shall contain the exact internet address where the full text of the EU declaration of conformity can be obtained". The Annex VII wording:

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]

The directive sets no file format, login rule or hosting period for that page.

Who must ship the DoC with the product

The Blue Guide (section 4.4) lists the acts that require products to be accompanied by the DoC: machinery, equipment for potentially explosive atmospheres, radio equipment, measuring instruments, recreational craft, lifts, rail systems and air traffic management constituents. For a product under the EMC Directive, the LVD or RoHS only, the DoC is kept and made available to the authorities on request.

Retention and who keeps what

Who	What	How long	Source
Manufacturer, EMC	Technical documentation and DoC	10 years after the apparatus has been placed on the market	Directive 2014/30/EU Article 7(3)
Manufacturer, LVD	Technical documentation and DoC	10 years after the electrical equipment has been placed on the market	Directive 2014/35/EU Article 6(3), Annex III point 4.2
Manufacturer, RED	Technical documentation and DoC	10 years after the radio equipment has been placed on the market	Directive 2014/53/EU Article 10(4)
Manufacturer, RoHS	Technical documentation and DoC	10 years after the EEE has been placed on the market	Directive 2011/65/EU Article 7(d)
Manufacturer, machinery (from 20 January 2027)	Technical documentation and DoC	At least 10 years after placing on the market or putting into service	Regulation (EU) 2023/1230 Article 10(3)
Authorised representative	DoC and technical documentation at the disposal of the authorities	Same period	Decision 768/2008 Article R3(2)(a); EMC Article 8(2)(a)
Importer	Copy of the DoC; ensure the file can be made available on request	Same period	Decision 768/2008 Article R4(8); EMC Article 9(7)

The Blue Guide (section 4.3) settles the starting point: "since the concept of 'placing on the market' refers to each individual product, the time period needs to be calculated from the moment when the individual product that is covered by the technical documentation is placed on the market". A model sold from 2020 to 2024 therefore keeps its file until 2034. The file "must be available when the product is placed on the market, whatever its geographical origin or location": the texts do not require it to be stored in the EU.

A non-EU manufacturer is not obliged by these acts to appoint an authorised representative, but Article 4 of Regulation (EU) 2019/1020 requires an operator established in the Union (manufacturer, importer, authorised representative or fulfilment service provider) for products under the EMC Directive, the LVD, RED, RoHS and the Machinery Directive. That operator must verify that the DoC and the technical documentation have been drawn up and keep the DoC available. Detail: authorised representative and importer obligations.

How the file is archived (paper or electronic, signed PDF, hashes, timestamps) is left to the manufacturer. What the texts do require is that the documentation can be supplied on reasoned request, "in paper or electronic form" in the wording of EMC Article 7(9), and that it covers every version placed on the market.

Families and variants

Module A asks for a DoC "for a product model" (LVD Annex III point 4.2; "for an apparatus model" in EMC Annex II point 5.2) that identifies the product for which it has been drawn up; RED Annex II says "for each radio equipment type". Neither text forbids one file covering several variants, but each variant has to be identifiable in the DoC (point 4, traceability) and in the file, and the evidence must cover each one. Where a variant changes a radio, a power supply or an enclosure, the risk analysis and the tests it affects have to address that variant; the component substitution rules show when a change triggers new evidence.

Dates that changed the file or the DoC

Date	Act	Effect
9 July 2008	Decision 768/2008/EC	Module A and the model declaration of Annex III
20 April 2016	Directives 2014/30/EU and 2014/35/EU	EMC and LVD recasts apply; DoCs reference 2014/30/EU and 2014/35/EU
13 June 2016	Directive 2014/53/EU	RED applies
18 May 2020	Implementing Decision (EU) 2020/659	EN IEC 63000:2018 cited under RoHS
18 November 2021	Implementing Decision (EU) 2020/659	EN 50581:2012 reference withdrawn
29 June 2022	Blue Guide 2022 (OJ C 247)	Current Commission reading of sections 4.3 and 4.4
30 January 2025	Implementing Decision (EU) 2025/138	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 notices
1 August 2025	Delegated Regulation (EU) 2022/30	RED articles 3(3)(d), (e), (f) apply to the categories it lists
20 January 2027	Regulation (EU) 2023/1230	Machinery Regulation applies; Annex IV file, digital DoC option
11 December 2027	Cyber Resilience Act	Full application

Claims the texts contradict

Common claim	What the text says
"A signed copy of the DoC is a mandatory piece of every technical file."	Module A, EMC Annex II and LVD Annex III do not list it; they require the DoC to be kept together with the file. RED Annex V(e) lists it.
"Each DoC must carry a unique number."	The footnote to the EMC, LVD and RED models: assigning a number is optional. Point 1 identifies the product (Blue Guide 4.4).
"The DoC must be signed by the CEO or the quality manager."	Annex III requires a name, function and signature "for and on behalf of" the manufacturer. The Blue Guide gives the managing director or a person with delegated responsibility as examples; the authorised representative may sign if mandated.
"The authorised representative can compile the technical file."	Drawing up the technical documentation "shall not form part of the authorised representative's mandate" (Decision 768/2008 Article R3(1), EMC Article 8(1)).
"LVD Annex III requires a list of safety-critical components with their certificates."	LVD Annex III point 2 lists (a) to (f) and the risk analysis. Component evidence comes from the harmonised standard applied.
"The EMC annex adds brand, type and serial numbers."	EMC Annex II adds an EMC assessment (point 2). Type, batch or serial numbers on the product are an Article 7(5) obligation, not a file item.
"Annex V requires a description of accessories, components and software."	That wording is in RED Article 10(8) (instructions) and Annex VI point 8 (DoC). Annex V asks for software or firmware versions affecting compliance.
"RED Annex V requires the allowed hardware and software combinations of software-defined radio equipment."	Annex V has no SDR item. RED Article 4 on combinations of radio equipment and software depends on a delegated act, and the RED Guide states there is none.
"IEC 63000 makes supplier declarations authoritative."	The text of RoHS and Decision 2020/659 says nothing of the kind; EN IEC 63000:2018 is the cited standard for the technical documentation, and the manufacturer remains responsible under Article 7.
"EN 301 489-1 V2.2.3 and EN 301 489-17 V3.2.4 go in a Wi-Fi DoC."	EN 301 489-1 is not cited on its own; the cited part is EN 301 489-17 V3.3.1 (Decision 2025/893).
"EN 62368-1:2020/A11:2020 gives presumption."	Under the LVD the cited edition is EN 62368-1:2014 with AC:2015; the RED list cites no EN 62368-1 edition.
"The simplified DoC says 'is in conformity with' and must be reachable without registration."	Annex VII says "is in compliance with Directive 2014/53/EU"; Article 10(9) requires the exact internet address, and no access rule.
"Retention runs 10 years from the first unit."	The Blue Guide counts from each individual product placed on the market, so from the last unit.
"The DoC must be in French in France, the file in the manufacturer language."	The DoC goes into the language(s) the Member State requires (Article R10(2)); the file is supplied in a language the authority easily understands (Article R2(9)). The languages are set nationally.

See also

• CE scope: which acts apply, and so which annexes the file has to follow.
• CE tests: the cited standards that fill the standards list and the test reports.
• RED technical file: Annex V element by element and the Annex VI DoC.
• Certification test plan, template and checklist: the TPP that links the technical file to actual test campaigns.
• Risk management, ISO 14971, IEC 31010, FMEA, FTA, HAZOP: the risk file that underpins the technical dossier.
• Component substitution rules by directive: when a BOM change forces a file update and a retest.
• Conflict minerals, Dodd-Frank, EU 2017/821, CMRT and EMRT: the supplier-declaration chain that feeds RoHS and REACH evidence.
• EU Ecolabel, PEF and LCA for electronic products: the environmental documentation often requested alongside the CE file.

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Sources & references

1. Decision No 768/2008/EC, Articles R2 to R10, Annex II (module A) and Annex III (model declaration), EUR-Lex eur-lex.europa.eu/eli/dec/2008/768/oj
2. Directive 2014/30/EU (EMC), Articles 7, 8, 15, Annex II (technical documentation) and Annex IV (DoC), EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
3. Directive 2014/35/EU (LVD), Articles 6, 15, Annex III (module A) and Annex IV (DoC), EUR-Lex eur-lex.europa.eu/eli/dir/2014/35/oj
4. Directive 2014/53/EU (RED), Articles 1(4), 10, 18, 21 and Annexes II, V, VI, VII, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
5. Directive 2011/65/EU (RoHS), Articles 7 and 13, Annex VI (DoC), EUR-Lex eur-lex.europa.eu/eli/dir/2011/65/oj
6. Implementing Decision (EU) 2020/659, EN IEC 63000:2018 cited, EN 50581:2012 withdrawn from 18 November 2021, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2020/659/oj
7. Regulation (EU) 2023/1230 on machinery, Article 10 and Annex IV (technical documentation), EUR-Lex eur-lex.europa.eu/eli/reg/2023/1230/oj
8. The Blue Guide on the implementation of EU product rules 2022 (2022/C 247/01), sections 4.3 and 4.4, EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022XC0629(04)
9. Implementing Decision (EU) 2022/2191, the RED harmonised standards list, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2022/2191/oj
10. Implementing Decision (EU) 2025/893, EN 301 489-3 V2.3.2 and EN 301 489-17 V3.3.1 cited with restrictions, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/893/oj
11. Implementing Decision (EU) 2025/138, EN 18031-1, -2 and -3 cited with restrictions, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/138/oj
12. IEC 63000: RoHS documentation, IEC webstore.iec.ch/en/publication/25985