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28 Jul 2026 7 min read

Machinery Regulation 2023/1230: Technical Documentation

The technical file is your machinery's compliance foundation. Regulation 2023/1230 redefines what it must contain (Annex IV) and how long you must keep it. This guide covers all 14 required components.

Machinery Regulation 2023/1230: The Technical Documentation Requirement (Annex IV)

In our previous articles, we covered the Declaration of Conformity (Annex V) and the general compliance timeline. This article focuses on what underpins every compliant machinery release: the technical documentation file, defined in Annex IV of Regulation (EU) 2023/1230.

The technical file is not a marketing document. It is evidence that you have performed a rigorous conformity assessment. Regulators, Notified Bodies, and market surveillance authorities expect it to be complete, organized, and demonstrable. If you cannot produce it on demand, your Declaration of Conformity becomes indefensible.

What the technical file is

The technical file is a compilation of documents and records that prove your machinery conforms to the essential health and safety requirements (EHSR) set out in the Regulation. It shows:

  • What hazards you identified in your machinery
  • What protective measures you implemented
  • Which standards you applied — and which you did not
  • How you validated that the machinery is safe

The technical file is not issued publicly. You retain it on file for at least 10 years after the machinery is placed on the market or put into service (Art. 10(3)).

However, you must be prepared to produce it on demand — to a Notified Body during a conformity assessment, to a competent authority during market surveillance, or to your customer if they request proof of compliance.

Who must create the technical file

Art. 10(2) states clearly: "Before placing machinery or a related product on the market or putting it into service, manufacturers shall draw up the technical documentation set out in Annex IV, Part A and carry out the relevant conformity assessment procedure referred to in Article 25 or have it carried out."

This applies to:

  • Machinery manufacturers
  • Manufacturers of related products (safety components, lifting accessories, chains, ropes)
  • Manufacturers of partly completed machinery (though their file follows a different template — Annex IV, Part B)

If you are a distributor or importer, you do not draw up the technical file — but you must ensure the manufacturer has done so and can produce it if required.

The 14 required components (Annex IV, Part A)

Regulation 2023/1230 defines exactly what must be in the technical documentation. These are not suggestions — they are mandatory components identified by letter (a) through (n).

a) Complete description

A thorough description of the machinery and its intended use. This should be detailed enough that someone unfamiliar with your product can understand what it does, what it is designed for, and under what conditions it operates.

b) Risk assessment and protective measures

This is the heart of the technical file. You must document:

  • A full list of the essential health and safety requirements applicable to your machinery
  • The protective measures you have implemented to meet each requirement
  • Identification of any residual risks that remain after mitigation

c) Design and manufacturing drawings

Technical drawings and schematics of the machinery, its components, subassemblies, and control circuits. These must be detailed enough to serve as a record of how the machinery was constructed.

d) Explanatory descriptions

Written descriptions and explanations necessary to understand the drawings, schematics, and operation of the machinery.

e) Applied harmonised standards

A list of any harmonised standards you applied under Art. 20(1). Include the reference number and date of each standard. If you applied a harmonised standard only partially, specify which sections or requirements you addressed.

f) Other technical specifications

If you did not apply harmonised standards (or applied them only partially), describe the alternative technical specifications or procedures you used to ensure conformity.

g) Reports and test results

Copies of design calculations, test reports, inspection records, examination results — anything that demonstrates compliance with the essential requirements.

h) Production conformity procedures

A description of the procedures, checks, and controls you use during production to ensure that manufactured units meet the design specifications.

i) Instructions for use and safety information

A copy of the instructions for use and the safety information section (Section 1.7.4 of Annex III), which together contain the essential health and safety requirements applicable to your machinery. Cybersecurity measures are defined in Annex III, Section 1.1.9, and must be included if applicable.

j) Declarations of incorporation (where applicable)

If the machinery incorporates partly completed machinery, you must include the EU Declaration of Incorporation (defined in Annex V, Part B) and assembly instructions for those components.

k) Certificates of conformity from other regulations

Copies of EU Declarations of Conformity issued for any machinery or products that were incorporated into your machinery under other Union harmonisation legislation (e.g., electrical equipment, lifts, pressure equipment).

l) Production series measures

If you manufacture in series, describe the internal procedures and quality measures you use to maintain conformity across production batches.

m) Software source code or logic (safety-related only)

For safety-related software, you must retain the source code or logic diagram. However, you are not required to include this in the technical file unless a competent national authority requests it on substantiated grounds and only to the extent necessary to verify conformity (Annex IV, Part A(m)).

n) Systems based on sensors and remote/autonomous operation

For machinery that relies on sensors, remote commands, or autonomous operation to control safety functions, include: a description of the system's general characteristics and capabilities, the data and development/testing/validation processes used.

Annex IV, Part B: Partly completed machinery

If you manufacture partly completed machinery, your technical file follows Annex IV, Part B — a different template. Partly completed machinery is machinery that will be incorporated into other machinery by another manufacturer. The documentation you provide to your customer (the downstream manufacturer) is distinct from the full technical file for completed machinery.

This article addresses Part A (completed machinery). Part B has a separate scope and requirements that merit their own discussion.

How to organize the technical file

Practical structure for the 14 components:

  1. Cover and index
  2. Machinery description (component a)
  3. Risk assessment section (component b)
  4. Technical design section (components c–f): drawings, standards, specifications
  5. Validation section (component g): test reports and inspection records
  6. Production controls (components h, l)
  7. Instructions and certificates (components i–k)
  8. Software and special systems (components m–n, if applicable)
  9. Conformity declaration summary

Use consistent naming, number volumes clearly, and ensure all components are easily retrievable.

Retention: 10 years minimum

You must retain the technical documentation for at least 10 years after the machinery is placed on the market or put into service (Art. 10(3)).

Choose a storage format that ensures long-term readability and accessibility: digital (PDF/A format is recommended), paper archive, or hybrid. Avoid proprietary formats that may become obsolete. You must be able to retrieve any document promptly on demand from an authority.

What the technical file does NOT require

Several things are not mandatory in the technical documentation:

  • Proprietary production processes — You do not need to disclose trade secrets or secret processes used in manufacturing
  • Supplier credentials or certifications — You do not need to include copies of your supplier's ISO certifications
  • Cost data or pricing — Manufacturing cost, material cost, or pricing information is not part of the technical file
  • Marketing materials — Sales brochures, advertisements, or promotional content have no place in a technical file
  • Customer feedback or complaints — Reviews and complaints are not technical documentation (though if complaints reveal a safety issue, your corrective action should be documented)
  • Internal management meetings — Meeting notes or email discussions are not technical documentation unless they document a design decision or conformity evaluation

The technical file is a technical and compliance document. Keeping it focused on those topics makes it leaner, more defensible, and easier to manage during audits.

Where technical files commonly fall short

  1. Incomplete risk assessment — EHSR list is generic without specific mitigation measures documented
  2. Design changes not reflected — Machinery updated but technical file not revised to match
  3. Test results lack traceability — Reports included but not linked to specific hazards or requirements
  4. Missing software validation — No documentation of procedures or test results for safety-related code
  5. No production controls — Quality checks not documented during series manufacturing
  6. Retention gaps — Older revisions or supporting documents discarded before retention period ends

The technical file is a living document, not a one-time compliance task. It must evolve with your machinery throughout its lifecycle.

Next steps

If you have not yet reviewed your current technical documentation against Annex IV requirements, this is the priority:

  1. Identify applicable EHSR — Work through Annex III of the Regulation and mark which requirements apply to your machinery
  2. Audit your current file — Verify that your technical documentation addresses each applicable requirement with a traceable protective measure
  3. Fill gaps — Create any missing components (test reports, procedures, software descriptions, production controls)
  4. Organize and version — Ensure the file is indexed, cross-referenced, and tracked with version control
  5. Plan retention — Establish a storage and retrieval system that ensures you can produce any document on demand

The technical file is not something you produce and forget. It is the foundation of your compliance programme and the evidence that backs your Declaration of Conformity.

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This article references Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023. Application date: 20 January 2027. For the full text, see EUR-Lex. This content is informational and does not constitute legal advice. Consult your Notified Body or regulatory advisor for guidance specific to your products.