Technical documentation file: required contents

Hugues Orgitelloupdated 7 Oct 202618 min read

The technical documentation, or technical file in the Machinery Directive wording, is the evidence behind a CE marking. Decision 768/2008/EC requires it to "make it possible to assess the product's conformity to the relevant requirements" and to "include an adequate analysis and assessment of the risk(s)". The Declaration of Conformity is the signed statement built on it. This page is the cross-cutting reference: the common base from module A, what each act adds, retention by act, who may ask for the file and in which language, and how the same evidence is packaged for the FCC and for Great Britain. It reads the texts as published on 7 October 2026; the CE technical file pillar covers the DoC point by point.

TL;DR:

• The base list is module A, point 2 (Decision 768/2008/EC, Annex II): risk analysis, description, drawings, explanations, standards applied, calculations and examinations, test reports. Each act restates it and adds items.
• Test reports do not have to come from an accredited laboratory under module A. Regulation (EU) 2019/1020 Article 11(5) only requires authorities to "take due account" of accredited reports.
• Retention is 10 years under EMC, LVD, RED and RoHS, counted per individual product, so from the last unit. Machinery and medical devices use their own wording ("at least 10 years", 15 years for implantable devices under the MDR).
• Only the manufacturer draws up the file. The authorised representative may keep it, not write it (Article R3(1)).
• No act requires English, a central filing or storage inside the EU. The file goes to an authority on reasoned request, in a language that authority easily understands.

What the technical file is, legally

Article R2(2) of Decision 768/2008/EC states that "manufacturers shall draw up the required technical documentation and carry out the conformity assessment procedure applicable". Only where compliance "has been demonstrated by that procedure" do they draw up the EU declaration of conformity and affix the marking. The file therefore comes first: it is the documented basis of the decision to mark, not paperwork assembled afterwards.

The content is set by the module text in Annex II of the Decision, which each sectoral act copies into its own annex: Annex II of the Directive 2014/30/EU (EMC), Annex III of the Directive 2014/35/EU (LVD), Annex V of the Directive 2014/53/EU (RED), Annex VII of the Directive 2006/42/EC (Machinery Directive) and Annex IV of the Machinery Regulation (EU) 2023/1230, which replaces it from 20 January 2027. The Blue Guide 2022 (section 4.3) summarises the rule: the documentation must contain information "to demonstrate the conformity of the product to the applicable requirements" and cover "the design, manufacture and operation of the product". For how the modules fit together, see conformity assessment modules A to H.

The common base: module A, point 2

Module A opens with three requirements before any list: the documentation must make it possible to assess conformity, must include an adequate analysis and assessment of the risks, and must "specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product". It then lists the elements to include "wherever applicable, at least".

Module A element	Text of the Decision	What usually fills it
Risk analysis	"an adequate analysis and assessment of the risk(s)" (opening paragraph)	Risks identified, applicable acts and essential requirements, how each is addressed
General description	"a general description of the product"	Name, type, intended use, variants covered, photos
Drawings	"conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc."	Schematics, PCB layout, mechanical drawings, bill of materials
Explanations	"descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product"	Block diagram, theory of operation
Standards	Harmonised standards and other technical specifications "applied in full or in part", the parts applied, and the solutions adopted where harmonised standards were not applied	Reference list with versions, justification for each requirement not covered
Calculations	"results of design calculations made, examinations carried out, etc."	Thermal, creepage and clearance, RF exposure calculations
Test reports	"test reports"	Reports for each standard applied, with the sample identified

Two consequences of the wording. First, "wherever applicable, at least" means the list is a floor: an item that does not apply should be recorded as not applicable, and the file may need more. Second, the Blue Guide (section 4.3) explains the risk analysis as a sequence: identify all possible risks, determine the applicable acts and essential requirements, document how each risk is addressed, and document how requirements not covered by a partly applied standard are dealt with.

What each act adds

The sectoral annexes restate module A and add items. The table compares the ones most often combined for an electronic product. An empty cell means the annex does not name the item.

Item	EMC 2014/30/EU, Annex II pt 3	RED 2014/53/EU, Annex V	Machinery Directive 2006/42/EC, Annex VII A	Machinery Regulation 2023/1230, Annex IV A
Risk analysis	Opening paragraph	Not in Annex V; Annex III pt 3(c)	"documentation on risk assessment" with the applicable requirements and protective measures	(b): risk assessment, requirements, protective measures, residual risks
Specific assessment	EMC assessment of the apparatus (point 2)	(i): Article 10(2) and 10(10) explanation	Research and tests on safe assembly and putting into service	(o): same research and tests
Copy of the DoC		(e)	"a copy of the EC declaration of conformity"	(k): DoCs of incorporated products, where appropriate
Instructions		(a)(iii): user information and installation instructions	"a copy of the 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
Notified body certificate		(f), where Annex III is used		Depends on the procedure
Series production	Point 4 obligation	Annex II pt 3 obligation	(b): internal measures for series manufacture	(h) production means; (l) internal measures
Language of the file	Language easily understood by the authority (Article 7(9))	Same on request (Article 10(12)); notified body language for Annex III (Article 21(3))	"one or more official Community languages"	Language easily understood by the authority on request (Article 10(10))

The LVD annex follows module A closely; RoHS points to module A through Article 7(b) and allows a single technical documentation with another act. The full five-column comparison including the LVD is on the CE technical file pillar, and the nine RED elements are read one by one on the RED technical file page.

Element notes

General description and variants

The description answers the first question of a market surveillance officer: which product, exactly. The Blue Guide (section 4.3) adds a rule templates often miss: after redesigns, "the technical documentation must reflect all versions of the product", how each version can be identified and how each was assessed, so that an authority holding an older unit finds the matching evidence. For radio equipment, Annex V(a)(i) asks for photographs or illustrations of external features, marking and internal layout.

Drawings and explanations

Module A asks for the drawings and for "descriptions and explanations necessary for the understanding" of them and of the operation of the product. A schematic that only its designer can read does not meet the second half. Machinery Directive Annex VII adds that the file need not include detailed plans of sub-assemblies "unless a knowledge of them is essential for verification of conformity".

Standards applied

The list gives each harmonised standard with its reference and version, states whether it was applied in full or in part, and names the parts applied. Where a harmonised standard was not applied, or does not cover a requirement, the file describes the other solution. The presumption of conformity comes only from references published in the Official Journal: for example, the LVD list cites EN 62368-1:2014 with AC:2015, and the RED list cites no edition of it, so it appears there as another technical specification for article 3(1)(a).

Risk analysis

The sentence requiring "an adequate analysis and assessment of the risk(s)" opens module A, the EMC annex and the LVD annex, so it is not an LVD or machinery speciality. For radio equipment it sits in Annex III point 3(c), not in Annex V; the RED Guide asks for it whatever the module (see RED technical file). For medical devices, the risk management file is usually built on ISO 14971. No act sets a format or a page count.

Test reports

Module A says "test reports" and nothing more: no act cited on this page requires them to come from an accredited laboratory. What accreditation changes is the weight of the evidence: under Article 11(5) of Regulation (EU) 2019/1020, where economic operators present reports or certificates issued by a body accredited under Regulation (EC) No 765/2008, market surveillance authorities "shall take due account" of them. Laboratories accredited to ISO/IEC 17025 are the usual choice for that reason. Where a pre-certified radio module is integrated, the host product still needs its own assessment; see RED technical file for what the RED Guide says about reused assessments.

The EU declaration of conformity

Module A point 4.2 requires the manufacturer to draw up the DoC "for a product model and keep it together with the technical documentation" for 10 years. Whether a copy is a listed file item depends on the act: RED Annex V(e) and Machinery Directive Annex VII list it; module A, the EMC annex, the LVD annex and Machinery Regulation Annex IV do not. Assigning a number to the declaration is optional under the EMC, LVD and RED models, and the DoC may be signed by a person with delegated responsibility, not necessarily the managing director (Blue Guide 4.4).

Instructions and software

Instructions are a file item under RED and machinery; under the other acts they are an obligation on the product (Article R2(7): instructions and safety information "in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned"). See user instructions and languages. Software versions are named only by RED Annex V(a)(ii) and, for safety software, by the Machinery Regulation. Recording the tested firmware build remains good practice for any connected product, because a change that alters compliance may call for a new assessment (see substantial modification).

How to structure the file

No act prescribes a layout. This structure follows module A, with the act-specific items kept in their own folders.

Section	Folder	Typical documents	Basis
0	Index and revision history	Contents, product versions and how each was assessed	Blue Guide 4.3
1	Product identification	Description, variants, intended use, photos, marking	Module A
2	Applicable acts	Which acts apply and why	Module A opening paragraph
3	Risk analysis	Risks, requirements, safeguards, residual risk	Module A opening paragraph
4	Design documentation	Drawings, schematics, PCB, BOM, explanations	Module A
5	Standards applied	References with version, parts applied, other solutions	Module A
6	Calculations and test reports	Per standard and per configuration	Module A
7	User information	Instructions and safety information per language	RED Annex V(a)(iii); machinery
8	Software and firmware	Versions affecting compliance	RED Annex V(a)(ii); Machinery Regulation (m)
9	Notified body	Certificates, annexes, additions	RED Annex V(f); module B
10	Declarations	Every signed DoC, current and previous	Module A point 4.2; RED Annex V(e)
11	Production	Series conformity measures	Module A point 3

The CE technical file pillar gives a working folder tree with the same logic.

Retention by act

Act	Who	Period	Counted from	Source
Directive 2014/30/EU (EMC)	Manufacturer	10 years	Apparatus placed on the market	Article 7(3)
Directive 2014/35/EU (LVD)	Manufacturer	10 years	Electrical equipment placed on the market	Article 6(3)
Directive 2014/53/EU (RED)	Manufacturer	10 years	Radio equipment placed on the market	Article 10(4)
Directive 2011/65/EU (RoHS)	Manufacturer	10 years	EEE placed on the market	Article 7(d)
Directive 2006/42/EC (Machinery, until 19 January 2027)	Manufacturer or authorised representative	At least 10 years	Date of manufacture or, for series, the last unit produced	Annex VII A point 2
Regulation (EU) 2023/1230 (Machinery, from 20 January 2027)	Manufacturer	At least 10 years	Placing on the market or putting into service	Article 10(3)
Regulation 2017/745 (MDR)	Manufacturer	At least 10 years; at least 15 for implantable devices	Last device covered by the DoC placed on the market	Article 10(8)

For the acts that say "placed on the market", 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 until 2025 therefore keeps its file until 2035. The authorised representative, if mandated, keeps the DoC and the file at the disposal of the authorities for the same period (Article R3(2)(a)); the importer keeps a copy of the DoC and ensures the file "can be made available to those authorities, upon request" (Article R4(8)).

Who holds it, who can ask for it, in which language

Who draws it up. The manufacturer. Article R3(1) is explicit: "the drawing up of technical documentation shall not form part of the authorised representative's mandate".

Who must be able to produce it. Since 16 July 2021, Article 4 of Regulation (EU) 2019/1020 requires an economic operator established in the Union (manufacturer, importer, authorised representative with a written mandate, or fulfilment service provider) for products under the EMC Directive, the LVD, RED, RoHS, the Machinery Directive and other listed acts. That operator verifies that the DoC and the technical documentation have been drawn up, keeps the DoC, and ensures the file can be made available on request. See authorised representative and importer obligations.

Where it is stored. The Blue Guide (section 7.4.1.1): it must be possible to make the file available in the Union, but "it does not need to be kept inside the Union", the operator need not store it itself, and it can be kept and sent "in paper or electronic form".

When an authority asks. Market surveillance authorities request the file on a reasoned request (Article R2(9)). The Blue Guide adds that the authority "cannot request it systematically", that the full file "should be requested only where clearly necessary", and that it is sufficient to provide the part related to the claimed non-conformity. It must be supplied within a reasonable period; failure to present it within an acceptable time frame "is a non-compliance and may constitute sufficient grounds for doubting the conformity of the product".

Language. The file goes to the authority "in a language which can be easily understood by that authority" (Article R2(9)). A translation request should be limited to the parts concerned, must give reasonable time, and cannot require an accredited or officially recognised translator; the authority may accept a third language (Blue Guide 7.4.1.1). The DoC, by contrast, is translated into the language or languages required by the Member State where the product is placed or made available (Article R10(2)).

Confidentiality. There is no public register. Member States must ensure that everyone who receives the contents of the file during market surveillance "is bound to confidentiality according to principles laid down in the national legislation" (Blue Guide 7.4.1.1).

The technical file versus the Declaration of Conformity

Aspect	Technical documentation	EU declaration of conformity
Nature	The evidence	The signed statement; by signing, the manufacturer assumes responsibility (Blue Guide 4.4)
Who draws it up	The manufacturer only (Article R3(1))	The manufacturer, or the authorised representative if mandated
Who sees it	Authorities on reasoned request; the notified body where one is involved	Authorities on request "without delay"; it accompanies the product where the act requires it (radio equipment, machinery and others listed in Blue Guide 4.4)
Language	Easily understood by the requesting authority	Language(s) required by each Member State
Retention	10 years (act-specific wording)	Same period, kept together with the file
Updates	Must reflect every version of the product	"Continuously updated"; a new version when one of its elements changes

The texts set no length for either document. A complete DoC with no file behind it is an unsupported claim; a complete file with no DoC leaves the product without the declaration the act requires. Both are needed. For the DoC itself, see the EU Declaration of Conformity guide.

EU, US FCC and Great Britain

The test data is largely reusable across markets; the container and its rules are not.

Aspect	EU technical documentation	US, FCC certification	US, FCC SDoC	Great Britain
Form	Held file, produced on reasoned request	Exhibits filed with the application on FCC Form 731 (2.1033(a))	Records held by the responsible party (2.938)	Held file, as in the EU
Filed with an authority?	No	Yes, through a TCB; public after grant except exhibits given confidential treatment	No	No
Content	Module A and the annex of each act	2.1033(b) for Parts 11, 15 and 18: instructions, circuit description, block diagram and schematic, measurement report, photographs, test set-up	2.938(a) and (b): design records, production test procedures, test results, test record detail	Same as the EU for regimes recognising CE; RED Article 21 for regulation 36B
Retention	10 years (EMC, LVD, RED, RoHS)	One year after marketing permanently ends, or until an investigation ends (2.938(f))	Two years (2.938(f))	Set by each UK regulation
Identifier	None central	FCC ID	None	None central

For FCC detail exhibit by exhibit, including confidentiality and labels, see FCC technical file. In Great Britain, the Product Safety and Metrology etc. (Amendment) Regulations 2024 (SI 2024/696), in force since 1 October 2024, keep CE marking recognised for most product areas, so a CE file serves as is. For radio equipment, regulation 36B of the Radio Equipment Regulations 2017, substituted by regulation 20 of that SI, lets a manufacturer use the UK marking on the EU basis if it "draws up the technical documentation in accordance with Article 21" and ensures the file and the conformity assessment records "are prepared in or translated into English". Details in the UKCA marking guide.

Dates that matter for the file

Date	Act	Effect on the file
9 July 2008	Decision 768/2008/EC	Module A content, Articles R2 to R4 on who keeps what
20 April 2016	Directives 2014/30/EU and 2014/35/EU	EMC and LVD recasts apply, with the module A file
13 June 2016	Directive 2014/53/EU	RED applies, with Annex V
16 July 2021	Regulation (EU) 2019/1020	Article 4: an EU operator must verify the file exists and ensure it can be produced
29 June 2022	Blue Guide 2022	Current Commission reading of sections 4.3, 4.4 and 7.4.1.1
1 October 2024	SI 2024/696 (Great Britain)	CE recognition kept; regulation 36B for radio equipment
1 August 2025	Delegated Regulation (EU) 2022/30	RED articles 3(3)(d), (e) and (f) apply: the file must cover them for the equipment concerned
20 January 2027	Regulation (EU) 2023/1230	Machinery Regulation applies; Annex IV file replaces Annex VII; Directive 2006/42/EC repealed
11 December 2027	Cyber Resilience Act	Full application

Common pitfalls

• Standards cited but not actually applied. The list names a harmonised standard, but the test reports do not cover the parts claimed, or cite a version whose reference is no longer published. See the harmonised standards guide.
• A generic risk analysis. A template not tailored to the product does not show how its actual risks are addressed, which is what the Blue Guide asks for.
• Module certificate used as the host evidence. A pre-certified radio module does not replace the assessment of the finished product.
• Drawings without explanations. Module A asks for both.
• Firmware version not recorded. For radio equipment, Annex V(a)(ii) requires the versions affecting compliance.
• Only the latest version kept. The file must reflect all versions of the product placed on the market, with how each was assessed.
• No one in the EU can produce the file. Under Article 4 of Regulation (EU) 2019/1020, the product needs an EU-established operator able to ensure the file can be made available.

A checklist table of contents

Use this as the index page. Every line should resolve to a document or a recorded "not applicable".

#	Item	Basis	Present
1	General description, models and variants, intended use	Module A	yes / no
2	Applicable acts and essential requirements	Module A opening paragraph	yes / no
3	Risk analysis and assessment	Module A opening paragraph	yes / no
4	Design and manufacturing drawings and schemes	Module A	yes / no
5	Descriptions and explanations of the drawings and the operation	Module A	yes / no
6	Harmonised standards applied with version, parts applied, other solutions	Module A	yes / no
7	Design calculations and examinations	Module A	yes / no
8	Test reports	Module A	yes / no
9	EMC assessment	EMC Annex II point 2	yes / no
10	Software or firmware versions affecting compliance	RED Annex V(a)(ii)	yes / no
11	User information and installation instructions	RED Annex V(a)(iii); machinery	yes / no
12	EU-type examination certificate and its annexes, where a notified body was used	RED Annex V(f); module B	yes / no
13	Explanation of compliance with Article 10(2) and of the Article 10(10) packaging information	RED Annex V(i)	yes / no
14	Signed EU declaration(s) of conformity	Module A point 4.2; RED Annex V(e)	yes / no
15	Series production measures	Module A point 3	yes / no
16	Revision history: product versions and how each was assessed	Blue Guide 4.3	yes / no

Claims the texts contradict

Common claim	What the text says
"Test reports must come from an accredited laboratory."	Module A says "test reports". Accreditation is not required by these acts; authorities must "take due account" of accredited reports (Regulation (EU) 2019/1020, Article 11(5)).
"A signed copy of the DoC is a mandatory piece of every technical file."	RED Annex V(e) and Machinery Directive Annex VII list it. Module A, the EMC and LVD annexes and Machinery Regulation Annex IV do not; they require the DoC to be kept together with the file.
"The DoC accompanies the product and is public."	Only where the act requires it, such as radio equipment and machinery (Blue Guide 4.4). Otherwise it is made available to authorities on request.
"Each DoC must carry a unique number."	Assigning a number to the declaration is optional under the EMC, LVD and RED models; point 1 identifies the product.
"The DoC must be signed by the CEO."	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" (Article R3(1)).
"Every act requires a list of safety-critical components with their certificates."	No annex cited here names such a list. Component evidence comes from the harmonised standard applied.
"Machinery retention runs from the date of placing on the market."	Directive 2006/42/EC counts at least 10 years from the date of manufacture or, for series, the last unit produced; Regulation 2023/1230 counts from placing on the market or putting into service.
"Retention runs 10 years from the first unit."	The Blue Guide counts from each individual product, so from the last unit.
"The file must be translated into the language of each Member State of sale."	It is supplied on request in a language the requesting authority easily understands; translation requests are limited to the parts concerned (Blue Guide 7.4.1.1).
"The authority can ask for the full file at any time."	It "cannot request it systematically"; the full file only "where clearly necessary".
"The file must be stored in the EU."	It must be possible to make it available in the Union, but it "does not need to be kept inside the Union" (Blue Guide 7.4.1.1).
"The FCC file is filed for every product."	Only for certification. SDoC equipment keeps records under 2.938 and files nothing.
"A file for Great Britain must be rebuilt on UK designated standards."	SI 2024/696 keeps CE recognised for most areas. For radio equipment, regulation 36B accepts a RED Article 21 file in English, with references to designated standards read as harmonised standards.

See also

• Getting started with certification: where to begin
• Harmonised standards and presumption of conformity
• Digital Product Passport (DPP) under the ESPR
• User instructions, safety information & languages
• Substantial modification: when to re-certify in the EU
• CE technical file and Declaration of Conformity
• RED technical file
• FCC technical file
• Conformity assessment modules A to H
• Self-declaration vs Notified Body

Working on building or auditing a CE technical documentation file for a specific product for a real product? AESTECHNO can audit your design and certification plan. Get in touch

Sources & references

1. Decision No 768/2008/EC, Articles R2 to R4, Annex II (module A) and Annex III, EUR-Lex eur-lex.europa.eu/eli/dec/2008/768/oj
2. The Blue Guide on the implementation of EU product rules 2022 (2022/C 247/01), sections 4.3, 4.4 and 7.4.1.1, European Commission eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022XC0629(04)
3. Directive 2014/53/EU (RED), Articles 10 and 21, Annexes II, III and V, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
4. Directive 2014/30/EU (EMC), Articles 7 to 9, Annex II, EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
5. Directive 2014/35/EU (LVD), Article 6 and Annex III, EUR-Lex eur-lex.europa.eu/eli/dir/2014/35/oj
6. Directive 2006/42/EC (Machinery), Annex VII part A, technical file, EUR-Lex eur-lex.europa.eu/eli/dir/2006/42/oj
7. Regulation (EU) 2023/1230 on machinery, Article 10 and Annex IV, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1230/oj
8. Regulation (EU) 2017/745 (MDR), Article 10(8), Annexes II and III, EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj
9. Regulation (EU) 2019/1020 on market surveillance, Articles 4 and 11(5), EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj
10. 47 CFR 2.1033, Application for certification (eCFR), eCFR www.ecfr.gov/current/title-47/section-2.1033
11. 47 CFR 2.938, Retention of records (eCFR), eCFR www.ecfr.gov/current/title-47/section-2.938
12. The Product Safety and Metrology etc. (Amendment) Regulations 2024 (SI 2024/696), regulation 20 (Radio Equipment Regulations 2017, regulation 36B), legislation.gov.uk www.legislation.gov.uk/uksi/2024/696/regulation/20/made