Technical documentation
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 its authorised representative) and produced on reasoned request to a competent market surveillance authority, normally within a period set by the relevant act.
The technical documentation underpins the manufacturer's EU Declaration of Conformity. A Declaration unsupported by an adequate technical file is, in itself, a documentary infringement irrespective of whether the product is materially compliant. Market surveillance authorities increasingly identify non-compliance by examining the technical documentation first and the product second.
Legal basis
- Decision No 768/2008/EC, Annex II, Module A (general contents); each sectoral act adopts these provisions and adds specifics.
- Sectoral Annexes — e.g., Annex IV of Regulation (EU) 2023/1230 (Machinery); Annex II of Regulation (EU) 2017/745 (Medical Devices); Annex III of Directive 2014/30/EU (EMC).
- Regulation (EU) 2019/1020 on market surveillance, Article 4 (the "responsible person" obligation to make documentation available) and Article 7 (cooperation duties).
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 exist in 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, GPSR-listed products, and others), an economic operator established in the Union must hold the technical documentation and make it available to authorities. That operator is the manufacturer if established in the EU, otherwise the authorised representative, the importer, or — only since the GPSR — a "fulfilment service provider" registered for that purpose.
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 contain, as applicable:
- A general description of the product. Name, model number, intended use, variants, target users.
- Conceptual design and manufacturing drawings. Schemes of components, sub-assemblies, circuits, hydraulic and pneumatic diagrams.
- Descriptions and explanations necessary to understand those drawings and the operation of the product.
- 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.
- Results of design calculations, examinations carried out, and test reports. Including reports from accredited test laboratories where applicable.
- A copy of the EU Declaration of Conformity.
Risk assessment as part of the file
Although not explicitly listed in the Decision 768/2008/EC baseline, the risk assessment is part of the technical file under every sectoral act that requires one. The Machinery Regulation (Annex IV, point 1.a), the Toy Safety Regulation (Article 19), Medical Devices Regulation (Annex II, Section 5), Low Voltage Directive (Annex III, point a), and PPE Regulation (Annex III, point 1.b) each require the risk assessment to be documented in the file. The Machinery Regulation goes furthest by specifying that the file must "list the essential health and safety requirements which apply to the machinery" and document how each has been addressed.
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 of the Regulation requires: the overall plan of the machinery, including control circuit drawings; full detailed drawings, with calculation notes, test results, and any certificates required to verify conformity; documentation on risk assessment; the standards and other technical specifications used; description of preventive measures taken to eliminate hazards or reduce risks; technical reports giving the results of tests carried out by the manufacturer or a chosen body; instructions for assembly, use, and maintenance. For partly completed machinery, an "assembly declaration" is required in place of the EU Declaration of Conformity (Article 16(5), 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 requires, in addition to the general elements: a description of operating frequencies, RF output power, modulation type, antenna specifications, and accessories or components that influence radio performance. The Commission's Decision (EU) 2017/1474 sets out the recommendations on technical documentation for radio equipment in detail.
Toy Safety Regulation (EU) 2025/2509
The Regulation (Article 19 and Annex IV) requires inclusion of: a description of the design and manufacture of the toy; chemical analyses where the toy contains substances of concern; the safety assessment under Article 18; and from 1 January 2026, references to the toy's Digital Product Passport identifier where applicable.
Construction Products Regulation (EU) 2024/3110
Replaces the predecessor Regulation 305/2011's "Declaration of Performance" structure with a stricter requirement for documentation of essential characteristics, intended use, and the assessment and verification of constancy of performance (AVCP) system. Article 21 and Annex IV set the contents, including technical descriptions, drawings, and any documentation from the Notified Body.
Retention period
The default rule is ten years from the date the last unit of the product was placed on the market (Decision 768/2008/EC, Annex II, Module A, point 2). Sectoral exceptions:
- Medical devices: 10 years for non-implantable devices, 15 years for implantable devices (Regulation (EU) 2017/745, Article 10(8)).
- In vitro diagnostic medical devices: 10 years (Regulation (EU) 2017/746, Article 10(7)).
- Construction products: 10 years under Regulation 2024/3110 (Article 22(7)).
- Pressure equipment: 10 years under Directive 2014/68/EU, Annex III Module-specific provisions.
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
The technical documentation must be drawn up in a language easily understood by the Notified Body involved (where one is involved) and by the competent national authority requesting it. In practice this means English for most Notified Bodies. Member State authorities may require translation into their national language for parts of the file when issuing a reasoned request — the language requirements differ act by act and Member State by Member State.
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 Regulation (EU) 2019/1020 (Articles 4 and 7), the economic operator established in the EU must provide the technical documentation "without undue delay" upon reasoned request from a market surveillance authority. Several sectoral acts specify shorter periods — for example, Article 10(9) of Directive 2014/35/EU (LVD) does not state a period, while the Medical Devices Regulation requires production within periods set by the authority (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 is treated as non-cooperation and may itself be sanctioned (see penalties for incorrect CE marking). It may also trigger a presumption of non-compliance, leading to withdrawal of the product from the market.
Common errors
- No risk assessment in the file. The most frequent finding in market surveillance audits across the LVD, Machinery, and Toy sectors is absence of a documented risk assessment, even where one was performed in practice. The verbal statement "we considered the risks" is not a risk assessment.
- List of standards without dated editions. A reference to "EN 60335-1" without the year and amendment number is unverifiable. The file must cite the dated edition published in the OJEU at the time of conformity assessment.
- Test reports from non-accredited or non-relevant laboratories. A test report not produced under ISO/IEC 17025 accreditation, or produced to a standard not corresponding to the applicable harmonised standard, has limited evidential value. The Commission's guidance on market surveillance increasingly treats reports from non-accredited labs sceptically.
- Failure to update the file when standards are revised. Standards are revised regularly. A file citing a withdrawn harmonised standard does not benefit from the presumption of conformity. The OJEU references must be checked at the time of placing each batch on the market.
- Treating "private label" repackaging as outside scope. An economic operator placing a product on the market under its own name or trade mark becomes the manufacturer (Decision 768/2008/EC, Article R6) and must hold a full technical file. Receiving a file from the original manufacturer "for reference" is insufficient; the file must support the rebranded product specifically.
- Cross-border retention without a responsible person. Files held only at the non-EU manufacturer's premises do not satisfy Article 4 of Regulation 2019/1020. An EU-established economic operator must be in a position to produce the file.
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. The Declaration's reference to "the technical documentation has been compiled in accordance with Annex II [or sectoral Annex]" is a substantive legal claim: the signed Declaration affirms that the file exists, is complete, and supports each statement in the Declaration. Drawing up the Declaration before the file is complete is an infringement of the manufacturer's obligations under Decision 768/2008/EC, Article R2.
Relationship to Notified Body certificates
Where a Notified Body has been involved (any module other than A), 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.