Machine CE Marking Technical File Checklist

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12 critical items still open - these are the highest-risk gaps.

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Scope and conformity route

Machine is confirmed as machinery within the scope of the directiveCRITICALApplicable directives are listed, such as low voltage, EMC and radio equipment where relevantCRITICALCheck whether the machine is on the Annex IV list and needs a notified body routeCRITICALHarmonised standards used are identified with edition and dateManufacturer or authorised representative in the EU is namedMachine identification, type and serial numbering rules are defined

Design and risk documentation

General description and intended use are written downCRITICALReasonably foreseeable misuse is recordedRisk assessment covers all lifecycle phases, including setup, maintenance and cleaningCRITICALHazards are mapped to protective measures and residual risk is statedCRITICALOverall assembly drawing and key subassembly drawings are filedControl circuit diagrams are filedCalculations and test results supporting safety are filed

Safety functions and verification

Safety functions are listed with required performance level or SILCRITICALSafety function verification and validation reports are filedCRITICALEmergency stop and guard interlock design is documentedElectrical equipment is checked against the relevant machinery electrical standardNoise, vibration or radiation measurements are filed where relevantHydraulic and pneumatic safety elements are documentedSoftware safety validation is documented where safety software is used

Components and suppliers

Safety components carry their own CE declarations or certificatesIncomplete machinery supplied by others has declarations of incorporationThird party test reports are filed with dates and scopeSupplier datasheets for safety relays, PLCs, drives and sensors are retainedBill of materials is linked to the as-built revision

Instructions and marking

Instructions are provided in the languages required for the destinationCRITICALInstructions cover installation, use, maintenance, residual risk and decommissioningWarning signs and pictograms are fitted and match the instructionsMachine nameplate carries name and address, designation, series or type, year of construction and CE markCRITICALInstructions for safe lifting and transport are included

Declaration and retention

EU declaration of conformity is drafted and signed by an authorised personCRITICALDeclaration lists the machine, standards, notified body if any, and signatoryTechnical file is retained for at least ten years after the last unit is madeCRITICALProcess exists to update the file after design or standards changesFile can be provided to authorities within a reasonable time

This is a working aid, not legal advice. Machinery Directive 2006/42/EC applies until the Machinery Regulation (EU) 2023/1230 applies from 20 January 2027. Confirm the applicable route with your notified body or counsel.

Link compliance files to as-built BOM

Optional review of how technical file documents can follow machine configuration and revision in your PLM or ERP.

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How to use this checklist

Work through the groups in order. Start with scope, because every later step depends on whether your machine is in scope and which conformity route applies. Then build the risk assessment, which is the spine of the file, and link each hazard to a protective measure and to evidence that the measure works. Tick items as they are filed, and record where each document lives so the file can be produced quickly. The critical items are the ones authorities and customers usually ask for first.

Keep one master index with document numbers and revisions.
Store the file against the machine type and as-built revision.
Update the file after any design change that affects safety.
Keep translations controlled with the source instructions.

What the technical file is

Under the Machinery Directive 2006/42/EC, the technical file is the set of documentation the manufacturer must hold to demonstrate conformity. It is not sent with the machine; it is available to market surveillance authorities on request. The customer receives the instructions and the declaration of conformity instead. Annex VII of the directive sets out its contents. Machines listed in Annex IV have extra conformity assessment requirements, which can include a notified body, so check that first.

Risk assessment and verification

A strong file connects three things: the hazard, the protective measure and the verification. For safety functions implemented in control systems, record the required performance level, the architecture, diagnostic coverage and the calculation or tool report, plus the validation test that proved it on the actual machine. Reviewers look for traces from each hazard to a test result. A risk assessment that is a generic table with no link to the design is the most common weak point.

Common mistakes and the new regulation

Common mistakes include missing instructions in the destination language, declarations that cite withdrawn standards, and files that describe the design as proposed rather than as built. Teams also forget that components integrated from other suppliers need their own paperwork. The Machinery Regulation (EU) 2023/1230 replaces the directive with application from January 2027 and adds points on software, cybersecurity and AI-enabled safety functions. Start mapping your file to it now if your machines will be sold after that date.

Frequently Asked Questions

Does the technical file go to the customer?

No. The customer receives the instructions and the EU declaration of conformity. The technical file stays with the manufacturer and is made available to market surveillance authorities on a reasoned request. Some customers ask to audit it during supplier qualification, which is a commercial arrangement.

How long must the technical file be kept?

For ten years after the last machine of that type has been manufactured under the Machinery Directive. Keep all versions that relate to units placed on the market, along with the standards editions applied, so you can show what was true at the time of supply.

Do I need a notified body?

Only for machines in Annex IV where harmonised standards are not fully applied, or for certain categories. Most machines follow internal production control. Check the Annex IV list and the standards you used early, because a notified body route changes schedule and cost.

Is this checklist enough to CE mark a machine?

No. It is a working aid listing typical contents. You still need competent engineering, correct standards, a real risk assessment and test evidence. Confirm your obligations with a qualified safety engineer, notified body or legal adviser for your specific machine and market.

If your engineering data, BOM revisions and compliance documents live in different systems, Netray can help link them so the technical file stays current with the as-built configuration.

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