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CE marking for machinery: steps & required documents
CE marking affixed to a machine is not a simple administrative formality. It is the outcome of a complete documentary process, and affixing it without a compliance file constitutes an offence. Here are the steps to follow and the documents to gather before you can legally CE mark a machine.
What is CE marking for a machine?
CE marking attests that a machine meets the essential health and safety requirements set out in the Machinery Directive 2006/42/EC, soon to be replaced by Regulation (EU) 2023/1230. It is the manufacturer who affixes this marking, under their own responsibility, no external body issues a generic CE certificate for the vast majority of machines.
CE marking is the condition for the free movement of the machine within the European Union. Without it, placing the machine on the market is illegal.
The 5 steps before affixing CE marking
1. Analysing the applicable requirements
Before anything else, you must identify which essential requirements of the Machinery Directive apply to the equipment concerned, and whether other European directives also come into play (electromagnetic compatibility, low voltage, pressure equipment depending on the case). A machine can fall under several directives simultaneously.
2. Risk assessment
This step identifies the hazards of the machine and the associated risk-reduction measures. It determines the content of all the documents that follow. This is specific technical work, generally carried out in-house by the manufacturer or entrusted to a specialist safety engineering provider.
3. Compiling the technical construction file
The technical file brings together the drawings, calculation notes, the risk assessment report and the list of harmonised standards applied. It must be retained for at least 10 years after the manufacture of the last unit.
> Machinery CE technical file: what must it contain exactly?
4. Drafting the instructions for use
Document provided to the user, written in the language of the country of destination, covering safety, commissioning, authorised maintenance and operating limits. Without compliant instructions, CE marking cannot be affixed.
> Mandatory instructions for use: regulatory content
5. The EC declaration of conformity
Document by which the manufacturer attests that the machine meets all applicable essential requirements. It must be signed by an authorised representative and accompany the machine when it is placed on the market.
Once these five steps are completed, and only then, the CE marking may be affixed.
Which assessment procedure applies to your machine?
Not all machines follow the same compliance procedure.
Cas général
Internal manufacturing control
For the vast majority of machines, the manufacturer carries out the assessment themselves, compiles the technical file and signs the declaration of conformity, without mandatory external involvement.
Annexe IV - Organisme notifié
EC type-examination by a notified body
Mandatory for machines listed in Annex IV of the Directive (mechanical presses, band saws, portable cartridge-operated fixing tools, platforms for lifting persons). The notified body examines a representative unit before it is placed on the market.
Knowing which category your machine falls into determines the rest of the documentary process, it is often the first question to settle on a special-purpose machine project.
The formal requirements of CE marking
The marking itself must comply with precise rules:
Minimum height of 5 mm
Indelible, legible and unobscured characters
Affixed visibly, legibly and durably on the machine itself
May only be affixed once the technical file has been compiled and the declaration of conformity signed
CE marking affixed before the technical file is finalised constitutes an offence, even if the machine is objectively safe.
What a manufacturer risks without complete documentation
CE marking affixed without a complete compliance file exposes the manufacturer to several direct consequences:
Withdrawal of the machine from the market by the supervisory authorities
Civil and criminal liability in the event of an accident
Export blockages to countries requiring CE compliance as a customs prerequisite
Commercial disputes with clients or distributors
For special-purpose machines in particular, which benefit from no pre-existing documentary standard, this exposure is all the greater since each machine constitutes a specific case requiring full documentation.
How LCSI supports documentary compliance
LCSI works on the documentary side of CE compliance: drafting and structuring the technical construction file, drafting compliant instructions for use, proofreading and auditing existing documents. We work alongside your technical teams or your specialist risk-assessment partners where this step is required.
Drafting and structuring the technical construction file
Drafting compliant instructions for use
Proofreading and auditing existing documents
We work on special-purpose machines, industrial equipment and production lines, providing full creation or revision of existing documentation.