The technical file for machine builders
What it must contain under 2023/1230 and 2006/42/EC
The technical file for machine builders: what it must contain under the Machinery Regulation (EU) 2023/1230 and the Machinery Directive 2006/42/EC, item by item, and what is often missing.
By Rickard Riekkola ·
What is the technical file?
The technical file is the manufacturer's evidence of how the machine meets the essential health and safety requirements that apply to it, in Annex III of the Machinery Regulation (EU) 2023/1230 and Annex I of the Machinery Directive 2006/42/EC. It has to exist before the machine is placed on the market or put into service.
It need not be a single binder or file, but it must be possible to compile it and hand it to an authority that asks for it. The customer does not get it: the customer gets the instructions for use and the EU declaration of conformity.
The regulation requires it to be kept for at least ten years after the machine was placed on the market or put into service (Article 10(3)).
Who draws it up?
Whoever counts as the manufacturer: the company that designs and builds the machine, an integrator who assembles a robot cell from machinery and partly completed machinery, and anyone who builds a machine for their own use. Under the regulation, also anyone who substantially modifies a machine (Article 18).
The contents, item by itemItems 1–16 follow Annex IV, Part A of the regulation. Items 17–19 belong to the same work.
- 01
Description of the machine and its intended use
What the machine does, how it is built, its limits and how it can be misused in ways that are reasonably foreseeable.
- Regulation
- Annex IV A, point (a)
- Directive
- Annex VII A, 1(a)
- 02
Applicable essential health and safety requirements
Which requirements in Annex III, or Annex I of the directive, apply to the machine, why the others do not, and where each requirement is addressed.
- Regulation
- Annex IV A, point (b)(i)
- Directive
- Annex VII A, 1(a)
- 03
Risk assessment, protective measures and residual risks
How the risk assessment was carried out, the hazards in every life phase, the protective measures and the risks that remain.
- Regulation
- Annex IV A, point (b)(ii)
- Directive
- Annex VII A, 1(a)
- 04
Drawings and diagrams
A general drawing, the detailed drawings needed, and electrical, pneumatic, hydraulic and safety circuit diagrams.
- Regulation
- Annex IV A, point (c)
- Directive
- Annex VII A, 1(a)
- 05
Description of how the machine works
A functional description with operating modes and safety functions that explains the drawings and diagrams.
- Regulation
- Annex IV A, point (d)
- Directive
- Annex VII A, 1(a)
- 06
Standards and common specifications applied
Each standard with its edition, which requirements it covers and whether it was applied in full or in part.
- Regulation
- Annex IV A, point (e)
- Directive
- Annex VII A, 1(a)
- 07
Other technical solutions
How the requirement is met where a harmonised standard has not been followed in full.
- Regulation
- Annex IV A, point (f)
- Directive
- Annex VII A, 1(a)
- 08
Calculations, tests and checks
Strength and stability, validation of safety functions, stopping times, noise and electrical testing.
- Regulation
- Annex IV A, point (g)
- Directive
- Annex VII A, 1(a)
- 09
Tests for safe assembly and putting into service
Reports showing that the machine can be assembled and put into service without risk.
- Regulation
- Annex IV A, point (o)
- Directive
- Annex VII A, after 1(b)
- 10
Production control
How you make sure the machine is built to the design.
- Regulation
- Annex IV A, point (h)
- Regulation only
- 11
Series production
The procedures that keep every machine produced in conformity with the requirements.
- Regulation
- Annex IV A, point (l), and Article 10(4)
- Directive
- Annex VII A, 1(b)
- 12
Instructions for use and marking
The instructions for use in the version delivered, in Swedish for machines used in Sweden, and the machine's marking.
- Regulation
- Annex IV A, point (i)
- Directive
- Annex VII A, 1(a)
- 13
Partly completed machinery built in
The declaration of incorporation and assembly instructions, for an industrial robot for example, and how the instructions were followed.
- Regulation
- Annex IV A, point (j)
- Directive
- Annex VII A, 1(a)
- 14
Declarations for machinery and products built in
EU declarations of conformity for built-in products that have their own, such as safety components and frequency inverters.
- Regulation
- Annex IV A, point (k)
- Directive
- Annex VII A, 1(a)
- 15
Safety-related software
The source code or programming logic of, for example, the safety PLC and the robot's safety configuration, kept for every version delivered.
- Regulation
- Annex IV A, point (m)
- Regulation only
- 16
Sensor-driven, remotely driven and autonomous machinery
The system's capabilities and limitations, and how it was developed, tested and validated.
- Regulation
- Annex IV A, point (n)
- Regulation only
- 17
EU declaration of conformity
The declaration with the machine's designation and serial number, the legislation and standards applied, the date and a signature.
- Regulation
- Articles 10(2) and 21, Annex V A
- Directive
- Annex VII A, 1(a), and Annex II A
- 18
Conformity assessment and CE marking
Which procedure was used, and whether the machine falls under Annex I or Annex IV, where a notified body may be required.
- Regulation
- Articles 24 and 25, Annex I
- Directive
- Articles 12 and 16, Annex IV
- 19
Storage and access
Where the file is kept, who is responsible for it and how it is handed to an authority.
- Regulation
- Articles 10(3) and 10(10)
- Directive
- Annex VII A, 2
Partly completed machinery
Partly completed machinery, such as an industrial robot, has its own technical documentation under Annex IV, Part B of the regulation and Annex VII, Part B of the directive. It covers the requirements the manufacturer has applied, and the rest is left to whoever builds it in.
Instead of instructions for use and an EU declaration of conformity, it comes with assembly instructions (Annex XI of the regulation, Annex VI of the directive) and a declaration of incorporation (Annex V, Part B of the regulation, Annex II, Part B of the directive). Partly completed machinery is not CE marked under the machinery legislation.
Modified machinery
Under Article 18 of the regulation, anyone who substantially modifies a machine counts as the manufacturer, for the whole machine or for the part the modification affects. That calls for a risk assessment of the modification, documentation for what it affects, a new EU declaration of conformity and CE marking.
If the modification is not substantial, still record how you reached that conclusion.
Common gaps
- Safety circuit diagrams are missing or do not match what was built.
- The validation of the safety functions covers an earlier version of the machine.
- The stopping time is assumed rather than measured.
- Standards are listed without their edition.
- The instructions for use do not cover the residual risks from the risk assessment.
- The declaration refers to the directive when the regulation applies.
- The documentation sits on several people's computers and cannot be compiled once someone has left.
How Verkio helps
Verkio has a checklist with the 19 items and, from the documents you have uploaded, suggests for each one whether it is present, partial, missing or not applicable. Every assessment is a draft until a person has approved it.
Every gap becomes an action with an assignee and a date, and the review package brings the checklist, the risk register and what remains together in a Word document.
A completed checklist shows what is there and what is missing. It is no proof that the machine meets the requirements.
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