Article 23 of Machinery Regulation 2023/1230: what the technical file must contain and why keeping it for 10 years is not optional
Direct answer: Article 23 of Regulation (EU) 2023/1230 requires the manufacturer to draw up and keep, for 10 years from the manufacture of the last unit, a technical file demonstrating that the machinery complies with the essential health and safety requirements of Annex III. The minimum content is set out in Annex IV Part A: a general description, drawings, the results of the risk assessment, a list of the harmonised standards applied, test reports, and the list of essential health and safety requirements met. If a market surveillance authority requests it and the manufacturer cannot provide it within the set deadline, the machinery is deemed not to comply with the essential requirements, with the enforcement consequences that entails. In this article we break down each required documentary block and the most common filing mistakes.
Regulation (EU) 2023/1230, fully applicable from 20 January 2027, retains the logic of the technical file under Directive 2006/42/EC but adds specific requirements for machinery with machine-learning components and strengthens the enforcement regime for failure to retain or provide the file.
The technical file (or technical documentation) is the set of documents, on paper or in electronic format, by which the manufacturer demonstrates that the machinery has been designed and manufactured in accordance with the essential health and safety requirements of Annex III of Regulation (EU) 2023/1230, and which must be able to be presented to the market surveillance authority that requests it within the deadline it sets.
10 years of mandatory retention
Article 23(1) sets the retention period at 10 years, counted from the date of manufacture of the machinery or, in the case of series production, from the date of manufacture of the last unit. The period is not shortened even if the manufacturer ceases operations: the obligation passes to whoever assumes its rights and obligations.
— Regulation (EU) 2023/1230, Article 23 and Annex IV Part A (OJEU L 165, 29.6.2023)
What must the technical file mandatorily include?
Article 23(1) refers to Annex IV Part A, which details the minimum content required before affixing the CE marking. This is not an indicative list: the absence of any of these documentary blocks makes the file incomplete for market surveillance purposes.
- General description of the machinery: model, intended use, reasonably foreseeable conditions of use, and a description of the variants covered by the same file if the manufacturer produces a range.
- Overall drawings and circuit diagrams: control circuits, power circuits and, where relevant, detailed drawings needed to check conformity, together with the corresponding calculation notes and test results.
- Risk assessment documentation: the method applied, the list of essential health and safety requirements relevant to the machinery, a description of the protective measures adopted to eliminate identified hazards or reduce risks, and, where applicable, an indication of the associated residual risks.
- Harmonised standards and other technical specifications applied: a complete list indicating which essential requirements each cited standard covers, including its reference published in the Official Journal of the European Union where one exists.
- Technical reports with 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 use of the machinery, in the version actually supplied to the user.
- For partly completed machinery, the declaration of incorporation and the assembly instructions.
- Where applicable, a copy of the EU Declaration of Conformity of the machinery or other products incorporated.
- A copy of the EU Declaration of Conformity of the machinery itself.
Does the technical file change for machinery with artificial intelligence?
Yes. For the categories in Annex I Part A related to self-evolving safety components based on machine learning — which we already analysed in detail in our article on Article 25 and the conformity assessment modules — the technical file must also include a description of the solutions adopted to ensure that the system's behaviour, after continuous learning while in service, continues to meet the essential safety requirements, and of the control mechanisms applied throughout the machinery's life cycle. This requirement did not exist under Directive 2006/42/EC and is one of the most significant new features of Regulation 2023/1230 for manufacturers of robotic machinery or machinery with machine vision.
Gather the general description and the drawings
Centralise the model, variants, overall drawings and circuit diagrams before starting the risk assessment, since these documents determine which hazards are identified.
Document the risk assessment with traceability
Each identified hazard must link to the protective measure adopted and, if a residual risk remains, to the corresponding warning in the instructions.
List the harmonised standards applied, standard by standard
It is not enough to cite the general standard: indicate which section of each standard covers which essential requirement, especially if several type-C standards apply partially.
Keep the original test reports on file
Keep the full report from the laboratory or body, not just the summary certificate; the authority may request the methodological detail.
Set up a 10-year retention system with an assigned owner
Designate who is responsible for the file after an employee leaves or a corporate change occurs; the legal deadline is not interrupted by internal reorganisations.
What happens if the authority requests the file and I don't have it ready?
Article 23(2) establishes that the manufacturer must submit the technical file, or relevant parts of it, to the market surveillance authority that requests it on reasoned grounds, within the deadline it sets. Failure to submit it on time is not a mere administrative shortcoming: under Article 23(3), if the manufacturer does not provide the complete file, the authority may presume that the machinery does not comply with the essential health and safety requirements of Annex III and adopt the corrective or restrictive measures provided for in the Regulation's market surveillance chapter, including withdrawal from the market. This unfavourable presumption is one of the reasons why the file cannot be treated as passive archive documentation, but as an asset that must be retrievable and deliverable quickly.
| File block | Legal basis | Minimum content |
|---|---|---|
| Description and drawings | Annex IV, Part A, points 1-2 | General description, overall and circuit drawings, calculation notes |
| Risk assessment | Annex IV, Part A, point 1(a) | Method, identified hazards, measures adopted, residual risks |
| Harmonised standards applied | Annex IV, Part A, point 1(a) | List of standards with OJEU reference and requirements covered by each |
| Test reports | Annex IV, Part A, point 3 | Complete reports from in-house laboratory or chosen third party |
| Instructions and AI report (if applicable) | Annex IV, Part A; Art. 23 | Copy of instructions and, if there are self-evolving components, life-cycle control |
Confusing the technical file with the instruction manual or the EU Declaration of Conformity. Both documents form part of the file, but they do not replace it: an authority that requests the complete technical file and receives only the declaration of conformity and the manual will consider the request unmet, with the risk of the presumption of non-compliance provided for in Article 23(3).
A practical case: the surprise inspection at Talleres Bordas
Talleres Bordas S.L., a fictional manufacturer of sheet-metal folding machines, received in 2026 a request from the market surveillance authority following an accident reported at a customer installation. The authority requested the complete technical file for a model manufactured three years earlier, with a 10-business-day deadline. The quality team quickly located the EU Declaration of Conformity and the manual, but took four additional days to retrieve the original test reports, which had been filed by an external supplier that had changed document management systems. The delay did not end up breaching the deadline, but it showed that the file was not centralised under a single owner, as Article 23 effectively requires by setting tight response deadlines.
IgeraIndustria in action: a technical file that is always locatable
How IgeraIndustria solves it
Question:
"We've received a market surveillance request asking for the technical file of a folding machine manufactured in 2023. What specific documents do we need to hand over under Art. 23?"
IgeraIndustria responds:
"Under Art. 23(1) and Annex IV Part A, you must hand over: general description and overall/circuit drawings, risk assessment documentation with measures adopted, a list of harmonised standards applied indicating which requirements each covers, complete test reports, a copy of the instructions supplied, and a copy of the EU Declaration of Conformity. Since the machinery was manufactured in 2023, it is still within the 10-year retention period (Art. 23(1)), so the obligation to retain and hand over the file remains in force until 2033."
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What language must the technical file be in?
The Regulation does not require the complete technical file to be drawn up in the language of the Member State where the machinery is marketed, unlike the instructions for use or the EU Declaration of Conformity. However, Article 23(2) requires the manufacturer to submit it to the authority that requests it, and in practice market surveillance authorities may require a translation of the essential parts if the original language hinders verification of conformity within the set deadline. This is why many manufacturers exporting to several Member States keep the base technical file in a common working language and prepare ad hoc translations on request.
In summary: the technical file under Article 23
- Must cover the 9 blocks of Annex IV Part A: description, drawings, risk assessment, standards applied, tests, instructions, associated declarations and the EU Declaration itself.
- Is retained for 10 years from the manufacture of the last unit, with no exceptions for cessation of activity.
- If there are safety components with machine learning, life-cycle control documentation is added.
- Failing to provide it on time creates a presumption of non-compliance with Annex III, not just a formal infringement.
- Centralise the file under a single owner so it can be handed over within the deadline set by the authority.
Frequently asked questions about Article 23
Must the technical file be handed over to the buyer of the machinery?
No, as a general rule. The technical file is internal manufacturer documentation made available to market surveillance authorities that request it on reasoned grounds, not to the final owner of the machinery. The buyer receives the instructions for use and the EU Declaration of Conformity, which are documents that must be supplied together with the machinery.
Can the technical file be kept in electronic format only?
Yes. Article 23 does not require paper format; it allows electronic format provided that its integrity, availability and legibility are guaranteed throughout the entire 10-year retention period, and that it can be handed over to the authority within the deadline set in each request.
What happens if the manufacturer closes down before the 10-year period ends?
The retention obligation does not disappear when operations cease. Under the Regulation's general regime on manufacturer obligations, responsibility for keeping the technical file passes to whoever assumes the manufacturer's rights and obligations — for example, in a sale of the company — or, failing that, may fall on the authorised representative if it was empowered to do so under its mandate.
Can the authorised representative keep the technical file instead of the manufacturer?
The authorised representative may receive a mandate to make the file available to the authorities, but the ultimate obligation to have prepared it and to ensure it exists remains with the manufacturer, as we detail in our article on manufacturer obligations and the cases in which the importer or distributor assumes that role.
Is the technical file the same as the documentation required by a notified body?
Not exactly. The technical file under Article 23 is the documentary base that the manufacturer always keeps, regardless of the conformity assessment procedure chosen. When a notified body is involved — for example in the EU type-examination — it may require additional or specific documentation within that procedure, but this does not replace the general technical file that the manufacturer must maintain under Article 23.
Can IgeraIndustria generate the technical file index automatically?
IgeraIndustria structures the technical file by Annex IV Part A blocks based on the documentation the manufacturer already has, flags outstanding documents still to be provided, and gives advance notice of the expiry dates of the 10-year retention period, although preparing and ensuring the accuracy of the technical content remains the manufacturer's responsibility.
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Last updated: July 2026 | Author: Jordi Bassols, Industrial Safety Engineer, Registered with COEIC | Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery, Article 23 and Annex IV Part A (OJEU L 165, 29.6.2023); Directive 2006/42/EC (in force until 19.1.2027). This article is for informational purposes only and does not constitute legal or engineering advice. IgeraIndustria — free trial. EUR-Lex — Regulation (EU) 2023/1230 This content is for informational purposes only and does not constitute legal or engineering advice. For the conformity assessment of your machinery, consult a notified body or a qualified industrial safety engineer.