Technical File for Machinery Imported into the EU: What Must Be in It and Who Must Hold It

Who must hold the technical file

The manufacturer draws up the file and remains responsible for it, wherever it is established. For machinery from outside the EU, the law adds holders inside the Union:

Contents under Annex VII Part A of the Directive (until 19 January 2027)

The technical file must demonstrate that the machinery complies with the requirements of the Directive and cover its design, manufacture and operation to the extent necessary for that assessment. The construction file comprises:

• a general description of the machinery,
• the overall drawing of the machinery and drawings of the control circuits, with the descriptions and explanations necessary to understand the operation of the machinery,
• full detailed drawings, accompanied by any calculation notes, test results, certificates and the like required to check the conformity of the machinery with the essential health and safety requirements,
• the documentation on risk assessment demonstrating the procedure followed, including the list of the essential requirements which apply to the machinery and the description of the protective measures implemented to eliminate identified hazards or reduce risks, and where appropriate the residual risks,
• the standards and other technical specifications used, indicating the essential requirements covered by them,
• any technical report giving the results of tests carried out by the manufacturer or by a body chosen by the manufacturer or its authorised representative,
• a copy of the instructions for the machinery,
• where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions,
• where appropriate, copies of the EC declarations of conformity of machinery or other products incorporated into the machinery,
• a copy of the EC Declaration of Conformity, and
• for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity.

The manufacturer must also carry out the research and tests on components, fittings or the completed machinery needed to determine whether it can be assembled and put into service safely, and include the reports and results. Detailed plans of bought-in subassemblies are not required unless knowledge of them is essential to verify conformity.

What is new under Annex IV Part A of the Regulation (from 20 January 2027)

The structure stays recognisable: description, risk assessment, drawings and explanations, standards, calculations and test results, instructions, declarations. Six additions matter for exporters:

Two things disappear from the annex: the copy of your own declaration as a listed component, and the separate person authorised to compile the technical file. The rules on language, location and availability move out of the annex into the manufacturer’s obligations in Article 10, which also cover the new requirements on protection against corruption and, where relevant, machinery with self-evolving behaviour. Check the consolidated text of the Regulation for the exact wording of each item; it has already been amended twice.

Retention: 10 years, counted differently

Under the Directive the technical file must be available to the competent national authorities for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced (Annex VII). Under the Regulation the manufacturer keeps the technical documentation and the EU Declaration of Conformity at the disposal of the authorities for at least 10 years after the machinery has been placed on the market (Article 10(3)), and the importer and the authorised representative carry a matching 10-year duty for what they hold.

For exporters the practical consequence is a date problem: the placing on the market of each unit, meaning its first supply on the Union market, starts the clock under the Regulation, and around the 20 January 2027 cut-over it also decides which law applies. Record that date per unit, and compute the retention end date from it rather than from the shipping date.

Language, location and availability

Under the Directive the technical file must be compiled in one or more official Community languages, except for the instructions, which follow the language rules of the country of use (Annex I section 1.7.4). An English file is therefore acceptable as such. It need not be located in the territory of the Community, nor be permanently available in material form, but it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC Declaration of Conformity (Annex VII).

Two rules cut across that comfort. On a reasoned request the authorities may ask for all information and documentation necessary to demonstrate conformity in a language they can easily understand; the Regulation places that duty on the manufacturer (Article 10) and Regulation 2019/1020 places it on the Article 4 operator (Article 4(3)(b)). And where a notified body examines your file, agree the working language with the body in advance. In practice: keep the file in English, keep the instructions in the languages of your markets, and budget for translating key documents such as the risk assessment if a national authority asks.

What happens if the file cannot be presented

The Directive is explicit: failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery (Annex VII). From there the market surveillance toolbox of Regulation 2019/1020 applies: the authority can require corrective action, prohibit or restrict the making available of the product, or order its withdrawal or recall, with a public warning where needed (Article 16). At the border, the authorities controlling imports must suspend the release for free circulation when required documentation is missing, when the CE marking appears false or misleading, or when no Article 4 operator is indicated or identifiable (Article 26).

From 20 January 2027 the Regulation lists incomplete technical documentation among the formal non-compliances that a member state must require the operator to end; if the non-compliance persists, the member state restricts or prohibits the making available of the machinery or ensures its withdrawal or recall. National penalties come on top: in Germany, conformity offences on machinery carry administrative fines of up to 100,000 euros per case today, and member states must have their penalty rules for the Regulation in place by 20 October 2026.

Structure checklist for exporters

A structure that works for both regimes, and that an EU importer or representative can navigate without you on the phone:

How CE-Copilot supports the technical file

• A 41-point checklist in eight sections per Annex VII of the Directive (Annex IV of the Regulation): general information, description, risk assessment, standards and directives, drawings and calculations, tests, instructions and conformity assessment, with mandatory and optional items marked and a status per item.
• File storage per checklist item for drawings, circuit diagrams, calculations and test reports, so the evidence sits next to the requirement it supports.
• The risk assessment per EN ISO 12100, the standards checklist, the test reports and the declaration of conformity come from the same project and feed the file automatically.
• Complete export of the project as one PDF or Word file, in English, that you can hand to your importer or authorised representative and archive in your own system for the retention period.
• What it does not do: the software does not decide what is safe, does not replace tests and is not legal advice. The AI drafts, the manufacturer checks and signs.

See the exporter overview for how the technical file fits into the rest of the EU process.

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