CE marking a machine means demonstrating that the machine meets the essential safety requirements of the Machinery Directive 2006/42/EC (and any other applicable directives) and affixing the CE marking. Here are the steps in order.
1. Identify the Machine and the Applicable Directives
Before figuring out how to CE mark a machine, you need to clarify: what counts as a "machine" (the directive's definition), which directives apply (besides Machinery, often EMC, Low Voltage, and PED where applicable) and which harmonised standards to use for the presumption of conformity. Also define the limits of use and the operating environment.
2. Carry Out the Risk Assessment
Risk assessment is the heart of safety. According to ISO 12100: identify hazards for every life-cycle phase (transport, assembly, use, maintenance), estimate the risk (severity and probability), define protective measures and verify the residual risk. Without an adequate risk assessment, you can't correctly draft the Technical File, the manual or the EC Declaration. CE marking software with a built-in risk matrix speeds up and standardizes this step.
3. Draft the Technical File
The Technical File (Annex VII of the Machinery Directive) must contain all the documentation that demonstrates compliance: a description of the machine, design documents, calculations, diagrams, test results, the risk assessment, compliance with the Essential Safety Requirements (ESR), a list of the standards applied, the EC Declaration of Conformity (or a copy), and the manual. It must be kept available to authorities for at least 10 years. For the details: Machinery Technical File: complete guide.
4. Draft the Manual and the EC Declaration
The instructions for use and maintenance must be supplied with the machine (on paper or in digital format, according to the regulation). It must contain the information needed for safe use, including residual risks and warnings. The EC Declaration of Conformity (Annex II.A) is the act by which the manufacturer declares that the machine is compliant. It must be signed and accompany the machine. With software like Reesly, you can generate both the manual and the EC Declaration consistently with the Technical File's data: see the Reesly workflow.
5. Affix the CE Marking and Place on the Market
CE marking must be affixed to the machine visibly, legibly and indelibly. Only then can the machine be placed on the market (or put into service), provided it is actually compliant. In some cases (machinery listed in Annex IV), involvement of a notified body is mandatory.
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Checklist: What You Need to CE Mark a Machine
- A documented risk assessment (ISO 12100)
- A complete Technical File (Annex VII)
- A signed EC Declaration of Conformity (Annex II.A)
- Instructions for use and maintenance
- CE marking affixed to the machine
- Any notified body certificate/involvement (if required)
Frequently Asked Questions
Who can CE mark a machine?
CE marking is affixed by the manufacturer (or their representative). An importer placing a machine from a third country must verify that the compliance procedure has been carried out and that the documentation is available.
How long does it take to CE mark a machine?
It depends on complexity. With dedicated CE marking software, the documentation part can be cut from days/weeks down to a few hours, while keeping compliance.
What do you need to CE mark a machine?
A risk assessment, a Technical File, an EC Declaration, instructions for use and maintenance, and CE marking on the machine. For some machinery (Annex IV), involvement of a notified body is required.
More on this topic: CE Marking Software, Technical File Software, Creating Instructions for Use and Maintenance, Machine Risk Analysis Software, Online CE Nameplate Generator, Technical Documentation Management, Machinery Technical File, EC Declaration of Conformity, Machinery Directive Regulation.