CE marking checklist: the complete guide to tick off
CE marking involves numerous steps and documents. With this field-tested checklist you keep the overview and make sure that no important item is forgotten. Ideal for CE officers, design engineers and project managers in mechanical engineering.
Preparation and directive research
In the first step you clarify which EU directives and regulations your product falls under. This step is decisive, because a mistake here can invalidate the entire subsequent process.
Carry out the risk assessment
The risk assessment per EN ISO 12100 is the heart of CE marking. It is mandatory for every machine and must be documented systematically and traceably.
Design and safety concept
Based on the risk assessment, the safety concept is drawn up and integrated into the design. This is where the previously defined protective measures are actually implemented.
Compile the technical documentation
The technical documentation must map the entire conformity assessment process traceably in accordance with Annex VII of the Machinery Directive (or Annex IV of the Machinery Regulation). It must be kept for 10 years after the last date of manufacture.
Conformity assessment and completion
Once the technical documentation is complete, the formal conformity assessment follows. Depending on the machine type, it can be carried out by the manufacturer themselves or by a notified body.
Time frame
The time needed for CE marking depends heavily on the complexity of the machine. As a rough guide:
| Phase | Simple machine | Complex installation |
|---|---|---|
| Directive research | 1 to 2 days | 3 to 5 days |
| Risk assessment | 3 to 5 days | 2 to 6 weeks |
| Safety concept | 2 to 5 days | 2 to 4 weeks |
| Technical documentation | 3 to 7 days | 4 to 8 weeks |
| Conformity assessment | 1 to 2 days | 2 to 8 weeks |
Important: CE marking is not a process that only begins at the end of product development. Ideally the risk assessment starts as early as the concept phase and accompanies the entire design. That is how costly rework is avoided.
Common mistakes in CE marking
Even experienced manufacturers keep making the same mistakes in CE marking. Avoid these typical pitfalls:
Not all directives considered
Many machines fall under several directives at once (e.g. Machinery Directive + EMC + Low Voltage). If one is overlooked, the declaration of conformity is incomplete.
Risk assessment only pro forma
A risk assessment that was obviously produced just to tick a box and contains no real hazard analysis will not withstand any inspection by the authorities.
Outdated standards applied
Harmonised standards are updated regularly. Applying a withdrawn standard no longer provides a presumption of conformity. Always check the current status in the Official Journal of the EU.
Operating instructions not in the national language
The operating instructions must be available in the official language of the country in which the machine is put into service. Instructions in English alone are not sufficient for the German market.
CE marking affixed incorrectly
The CE mark has a standardised design (based on a grid). It must be at least 5 mm high and affixed visibly and indelibly to the product or the rating plate. Stickers that come off easily are not sufficient.
Documentation not retained
The technical documentation must be available for at least 10 years from the last date of manufacture. For series machinery that means: 10 years after the last unit produced.
Which documents do you need?
In summary, you need the following documents for complete CE marking:
Risk assessment
Per EN ISO 12100
Technical drawings
Overview + detail drawings
Circuit diagrams
Electrical, pneumatic, hydraulic
List of standards
Harmonised standards applied
Test reports
Measurements, tests, validation
Operating instructions
In the national language
Declaration of conformity
Per Annex II Machinery Directive or Annex V Machinery Regulation
Safety evidence
PL/SIL calculation per EN ISO 13849-1 or EN 62061
You define the required performance level (PLr) in the functional safety module and document the achieved result there as well. The calculation of the achieved PL per EN ISO 13849-1 is carried out in SISTEMA, the free tool from the IFA of the DGUV. CE-Copilot does not replace SISTEMA. The SISTEMA report then belongs in your technical file as evidence.
Work through the CE checklist digitally
CE-Copilot digitises your CE checklist and guides you through every step with AI support, from the risk assessment to the finished declaration of conformity.
More articles
When is CE marking mandatory?
Which products are affected and what non-compliance costs.
Technical file for machinery
All requirements for the technical documentation.
Risk assessment per EN ISO 12100
The complete guide to a standards-compliant risk assessment.
CE marking guide: step by step
The complete guide to the CE process.