CECheck The reference for CE marking

Technical documentation

Last reviewed: October 2026 · Sources listed at the end of this page.

The technical documentation — usually called the technical file — is the body of evidence that demonstrates a product's conformity with the applicable EU harmonisation legislation. Its general contents are specified in Annex II of Decision No 768/2008/EC (Module A, point 2) and in the equivalent provisions of every sectoral directive and regulation. The technical file is not submitted to any authority on its own initiative. It is held by the manufacturer (or, where mandated, its authorised representative) and produced on reasoned request to a competent national authority.

The technical documentation underpins the manufacturer's EU Declaration of Conformity. Missing or incomplete technical documentation is a formal non-compliance in its own right, even if the product itself is safe (Decision 768/2008/EC, Annex I, Article R34).

At a glance. The technical file is the evidence behind the CE mark. It is required for every CE-marked product and compiled before placing on the market. It stays with the manufacturer and goes to authorities only on request; a Notified Body sees it only where one is involved. Key rule: keep it for 10 years after the last product of the model is placed on the market, unless the act says otherwise.

Legal basis

Scope and applicability

Every product placed on the EU market that bears CE marking must have a corresponding technical file. The file is compiled before the product is placed on the market — not after a market surveillance request arrives. It is updated for each variant of the product that materially differs in design, materials, function, or intended use. A single technical file may cover a family of products provided their conformity-relevant features are identical and any differences are documented.

The file must be obtainable from within the EU. Since 16 July 2021, Article 4 of Regulation (EU) 2019/1020 requires that for products covered by 18 listed Union harmonisation acts (including the LVD, EMC, RED, Machinery, PPE, Toy Safety, RoHS, and others), an economic operator established in the Union must ensure that the technical documentation can be made available to authorities on request (Article 4(3)). That operator is the manufacturer if established in the EU; otherwise the importer, an authorised representative, or, failing those, a fulfilment service provider (Article 4(2)).

General contents

The Module A baseline (Annex II of Decision 768/2008/EC) requires the technical documentation to make it possible to assess the product's conformity. It must include an adequate analysis of the risks and, as applicable, the following. Item 6 is not in the Module A list, but some acts require it (for example Directive 2014/53/EU, Annex V).

  1. A general description of the product. Name, model number, intended use, variants, target users.
  2. Conceptual design and manufacturing drawings. Schemes of components, sub-assemblies, circuits, hydraulic and pneumatic diagrams.
  3. Descriptions and explanations necessary to understand those drawings and the operation of the product.
  4. A list of harmonised standards applied in full or in part, referenced as published in the OJEU (year and dated edition), and descriptions of solutions adopted to meet essential requirements where standards have not been applied.
  5. Results of design calculations, examinations carried out, and test reports.
  6. A copy of the EU Declaration of Conformity.

Risk assessment as part of the file

The Decision 768/2008/EC baseline itself requires the technical documentation to include "an adequate analysis and assessment of the risk(s)" (Annex II, Module A, point 2), so the risk assessment is part of the technical file under every act built on that model. The Machinery Regulation (Annex IV, Part A, point (b)), the Medical Devices Regulation (Annex II, Section 5), the Low Voltage Directive (Annex III, point 2), and the PPE Regulation (Annex III, point 1(b)) each require it expressly; for toys the equivalent is the safety assessment (Regulation 2025/2509, Article 25 and Annex V, from 1 August 2030). The Machinery Regulation goes furthest: the file must list the applicable essential health and safety requirements and describe the protective measures implemented for each.

Sector-specific additions

Each sectoral act adds specific items to the file. The most consequential additions:

Machinery Regulation (EU) 2023/1230 (and Directive 2006/42/EC)

Annex IV, Part A of the Regulation requires, among other items: a complete description of the machinery and its intended use; the risk assessment documentation; design and manufacturing drawings; the harmonised standards or common specifications applied; reports and results of calculations, tests and inspections; the means used to ensure production conformity; a copy of the instructions; for series production, the internal measures that keep it in conformity; and, on reasoned request where necessary, the source code or programming logic of safety-related software. Until 20 January 2027, Annex VII of Directive 2006/42/EC applies. Partly completed machinery has an EU Declaration of Incorporation (Annex V, Part B) and its own list in Annex IV, Part B.

Medical Devices Regulation (EU) 2017/745

Annex II of MDR lists the most extensive technical documentation requirements in EU law: device description and specification (Section 1); information to be supplied by the manufacturer (Section 2); design and manufacturing information (Section 3); general safety and performance requirements (Section 4, mapped against Annex I); benefit-risk analysis and risk management (Section 5); product verification and validation, including clinical evaluation per Annex XIV (Section 6). Annex III adds post-market surveillance documentation including the post-market surveillance plan and Periodic Safety Update Report (Article 86) for Class IIa, IIb, and III devices.

Radio Equipment Directive 2014/53/EU

Annex V adds to the general elements: photographs or illustrations of external features, marking and internal layout; versions of software or firmware affecting compliance; user information and installation instructions; a copy of the EU Declaration of Conformity; and, under Module B, a copy of the EU-type examination certificate.

Toy Safety Regulation (EU) 2025/2509

From 1 August 2030, Article 27 and Annex V require: a detailed description of the design and manufacture, including lists of components, materials, substances and mixtures; the safety assessment under Article 25; a description of the conformity assessment procedure; the addresses of the places of manufacture and storage; and test reports or certificates, depending on the route. Until then, Directive 2009/48/EC applies.

Construction Products Regulation (EU) 2024/3110

Article 22(3) requires technical documentation as the basis for the declaration of performance and conformity. It must indicate the declared use, the elements needed to demonstrate performance and conformity, the procedures in place, the applicable assessment and verification system (Annex IX), any simplified procedures applied, and the calculation of environmental sustainability performance. Product families not yet moved across remain under Regulation 305/2011.

Retention period

The default rule is ten years after the product has been placed on the market (Decision 768/2008/EC, Annex II, Module A, point 4.2; repeated in sectoral acts), which the Blue Guide reads as the last item of the product model. Specific rules:

Retention runs from the last unit placed on the market, not from the date of compilation. For a product manufactured continuously over several years, the retention clock starts only when production ends.

Language and format

Documents supplied to an authority must be in a language it can easily understand (Decision 768/2008/EC, Annex I, Article R2(9); Regulation (EU) 2019/1020, Article 4(3)(b)). A file does not need to be kept in every Member State language, but a translation may be needed when an authority asks.

The file may be kept in paper or electronic form. Electronic format is the practical norm. Access controls must allow rapid retrieval and transmission to authorities. Where the file references documents held elsewhere (test reports at laboratories, certificates at Notified Bodies), those references must be traceable; the manufacturer remains responsible for producing the underlying evidence.

Access by market surveillance authorities

Under Article 4(3)(b) of Regulation (EU) 2019/1020, the economic operator established in the EU must, further to a reasoned request from a market surveillance authority, provide the information and documentation needed to demonstrate conformity. Most sectoral acts do not fix a period — for example, Article 6(9) of Directive 2014/35/EU (LVD) does not — and authorities generally set their own deadline in the request; the Medical Devices Regulation has its own rule (Article 10(14)).

A request need not be motivated by suspicion of non-compliance. Authorities may conduct random sampling checks or thematic campaigns. Failure to produce the file may itself be sanctioned (see penalties for incorrect CE marking). If documentation remains unavailable or incomplete, the authority can restrict the product or require its withdrawal or recall (Article R34).

Common errors

Relationship to the Declaration of Conformity

The EU Declaration of Conformity is signed on the basis of the technical file, not the other way round. By signing, the manufacturer states that conformity has been demonstrated, so the file must exist and support each statement in the Declaration. The Declaration comes after compliance has been demonstrated (Decision 768/2008/EC, Annex I, Article R2(2)).

Relationship to Notified Body certificates

Where a Notified Body has been involved, the certificates issued by the body — EU type-examination certificates under Module B, quality assurance approval certificates under Modules D, E, H — form part of the technical documentation. The Notified Body retains its own dossiers, but the manufacturer must hold copies and produce them on request. Certificates have validity dates and renewal requirements that the manufacturer must track.

Frequently asked questions

Do I have to send the technical file to an authority or the EU?

No. There is no filing or registration step for the file. You keep it and provide it when a competent authority makes a reasoned request. A Notified Body reviews it only where your conformity assessment route involves one.

Can one technical file cover several product variants?

Yes, if the file identifies each variant and the differences are documented. A variant that changes design, materials, function or intended use in a way that matters for conformity needs its own assessment within the file.

Who keeps the file if the manufacturer is outside the EU?

The manufacturer stays responsible for it. Under Article 4 of Regulation (EU) 2019/1020, an economic operator established in the EU must also be able to make it available to authorities.

Does the technical file have to be in English?

No single language is prescribed. It must be supplied in a language the requesting authority can easily understand, which may mean translating parts of it.

Sources

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