Building a CE Technical File: a practical checklist

The Technical File is the evidence behind the CE marking. Nobody asks to see it on a good day — but if a market surveillance authority makes a reasoned request, or after an accident, it is the document that shows whether the machine was designed and assessed properly.

This checklist follows the content required by Annex VII Part A of the Machinery Directive 2006/42/EC. Regulation (EU) 2023/1230, which applies from 20 January 2027, carries the same principles into its Annex IV.

Step 1 — Define the product and the legislation

Before collecting documents, be clear about what you are certifying.

• Is it machinery, an assembly of machinery, or partly completed machinery?
• Which legislation applies? Typically the Machinery Directive (or Regulation) and the EMC Directive 2014/30/EU, plus ATEX, the Radio Equipment Directive or the Pressure Equipment Directive where relevant. For machinery, electrical safety is addressed through the Machinery Directive’s essential requirement 1.5.1, which refers to the safety objectives of the Low Voltage Directive.
• Is the machine in an Annex IV category? If so, decide the conformity route: full application of harmonised standards with internal checks, EC type-examination, or full quality assurance.

Step 2 — Description and drawings

• General description of the machinery, its intended use and its limits.
• Overall drawing of the machinery.
• Control circuit diagrams, with descriptions and explanations needed to understand how the machine operates.
• Detailed drawings, calculation notes and test results needed to check conformity with the essential requirements.

Step 3 — Risk assessment

The risk assessment is the core of the file. It must document:

• The list of essential health and safety requirements that apply to the machine.
• The protective measures implemented to eliminate hazards or reduce risks.
• Where appropriate, the residual risks — which must then appear in the instructions.

Use the EN ISO 12100 method: limits, hazard identification across all life-cycle phases, risk estimation and evaluation, and the three-step method. Make sure the assessment matches the machine as built, not as quoted.

Step 4 — Standards applied

• List the harmonised standards and other technical specifications used, with editions.
• State which essential requirements each standard covers.
• Where a harmonised standard is applied only partly, record which clauses — presumption of conformity covers only what is applied.

Step 5 — Control system evidence

For every safety function that a risk reduction measure depends on:

• Safety requirements specification.
• Required level (PLr to EN ISO 13849-1 or SIL to IEC 62061) and how it was determined.
• Verification that the achieved PL or SIL meets the requirement.
• Validation records — analysis and testing, including fault injection — per EN ISO 13849-2 or IEC 62061.

Step 6 — Test reports

• Technical reports with the results of tests carried out by you or by a body of your choice.
• Electrical tests as required by EN 60204-1 — for example continuity of the protective bonding circuit, insulation resistance and functional tests.
• Measurements needed to support declarations, such as noise emission values required in the instructions.
• EMC evidence, if the EMC Directive applies.

Step 7 — Instructions

• A copy of the instructions, in the official language(s) of the country where the machine is placed on the market or put into service.
• Residual risks from the risk assessment reflected in warnings and instructions.
• EN ISO 20607 can be used as a framework for drafting the instruction handbook.

Step 8 — Partly completed machinery and incorporated equipment

• Declarations of Incorporation for any partly completed machinery you incorporated.
• The relevant assembly instructions — and evidence that you followed them.
• Copies of Declarations of Conformity for machinery or products incorporated.

Step 9 — Series production

• For series manufacture, the internal measures that ensure every unit conforms to the design described in the file.

Step 10 — Declaration of Conformity and CE marking

• EC Declaration of Conformity with the content required by Annex II 1.A, including the name and address of the person authorised to compile the Technical File, who must be established in the EU.
• CE marking affixed in the vicinity of the manufacturer’s name, visibly, legibly and indelibly.

Step 11 — Retention and change control

• Keep the file for at least 10 years after manufacture of the machine — or of the last unit, for series production.
• Keep it current: any design change should trigger a review of the risk assessment, calculations, tests and instructions it affects.
• The file does not have to be on paper, but you must be able to assemble it within a reasonable time on request.

Common gaps to check before you sign

• A risk assessment that no longer matches the final design.
• Residual risks identified but missing from the instructions.
• Standards listed without editions, or editions that are no longer current.
• Safety functions with a PLr but no verification or validation records.
• A Declaration of Conformity without the person authorised to compile the file.

Where MSA fits

MSA generates the CE Technical File from your requirements, drawings and system models, together with the risk assessment, PLr / SIL calculations, validation protocols and test certificates it depends on. Every item is traceable to its inputs, so a design change regenerates the affected sections rather than leaving them out of date. Output is client-ready Word, PDF and Excel.

This checklist is a practical aid, not legal advice. Always refer to the official text of the applicable legislation.