Regulation & compliance
CE Technical File
The technical documentation behind the CE marking: the evidence that the machine meets every applicable essential requirement.
CE marking and the machinery Technical File
- Category
- Regulation & compliance
- Scope
- EU
- Edition / refs
- 2006/42/EC Annex VII · (EU) 2023/1230 Annex IV
MSA output
- CE Technical File
- Risk assessment & PLr / SIL calculations
- Validation protocols & test certificates
- Word, PDF and Excel exports
What is CE Technical File?
The CE marking is the manufacturer’s declaration that a product meets all applicable EU harmonisation legislation. For machinery it may only be affixed once the conformity assessment is complete, the Technical File has been compiled and the Declaration of Conformity has been signed.
The Technical File is the evidence behind that declaration. It is not normally submitted to anyone, but it must be made available to market surveillance authorities on reasoned request and kept for at least 10 years after the machine — or the last unit of a series — is manufactured. It does not have to be held on paper, but it must be possible to assemble it within a reasonable time.
Who it applies to
- Machine builders and OEMs
- System integrators CE marking assemblies of machinery
- Safety and compliance engineers compiling technical documentation
- Manufacturers whose machines also fall under ATEX, Low Voltage or EMC legislation
Key requirements
- 01
Description and drawings
General description, overall drawing, control circuit diagrams with descriptions, and the detailed drawings and calculations needed to check conformity.
- 02
Risk assessment documentation
The applicable EHSRs, the protective measures implemented and the residual risks.
- 03
Standards applied
The harmonised standards and other technical specifications used, and the EHSRs they cover.
- 04
Test reports
Technical reports with the results of tests carried out by the manufacturer or a body of its choice.
- 05
Instructions
A copy of the instructions for the machinery.
- 06
Declarations
Copies of the Declaration of Conformity, plus Declarations of Incorporation and assembly instructions for any partly completed machinery incorporated.
Summary for orientation only. Always refer to the current official text of CE Technical File and any applicable legislation.
MSA for CE Technical File
What MSA generates
Evidence produced from your engineering inputs, traceable end to end and exported to Word, PDF or Excel.
CE Technical File
Generated from requirements, drawings and system models, organised to the structure the legislation expects.
Risk assessment & PLr / SIL calculations
The analysis the file depends on, linked from hazard to measure.
Validation protocols & test certificates
Test evidence that closes the loop on each protective measure.
Word, PDF and Excel exports
Client-ready documents in the formats your customers and auditors already use.
Frequently asked questions
Do I have to send the Technical File to a notified body?
Not for most machinery. Notified-body involvement is only required for certain high-risk categories — Annex IV under the Directive, Annex I under the Regulation — depending on the conformity route chosen.
How long must the Technical File be kept?
At least 10 years from the date of manufacture of the machine or, for series production, of the last unit produced.
Can the Technical File be electronic?
Yes. It does not need to be permanently available in material form, but it must be possible to assemble it and make it available within a period commensurate with its complexity.
Generate CE Technical File evidence from your own data
See how MSA turns your requirements, drawings and process data into certification-ready documents — fully offline.