CE marking: the six-step plan

What the marking actually signifies

CE stands for Conformité Européenne. The letters are not a quality mark or a quality assessment. By applying the marking, the manufacturer indicates that they take responsibility for the product’s conformity with all applicable European requirements.

That distinction is important. The marking is a declaration by you, not an approval from an authority. A regulator does not accept it as proof but may always ask for the underlying documentation. That underlying documentation is the technical file.

The regulation adds that the CE marking is the only marking that confirms the product meets those requirements. Other markings may be added, as long as they do not impair the visibility, legibility, and meaning of the marking.

The six steps

Every CE process follows the same route, from simple to complex. What varies is the intensity per step, not the sequence. Anyone who skips step one and proceeds directly to testing almost always tests against the wrong requirements and pays the bill twice.

1. Determine which legislation applies. Identify which directives and regulations apply to your product. Virtually every product with a plug or a radio function falls under more than one.
2. Select the standards. Harmonized standards translate legal requirements into measurable specifications. Full application often results in a simpler assessment route.
3. Identify requirements and risks. Perform the risk assessment and establish the requirements for design, use, marking, and packaging.
4. Test the product. In a laboratory or internally, where the latter is permitted. The outcome should be recorded for each clause of the standard.
5. Compile the technical file. Drawings, calculations, test reports, manuals, and traceable model and serial numbers. The retention period is generally ten years.
6. Sign and apply the marking. The EU Declaration of Conformity is signed by the manufacturer. Only then is the marking applied to the product or the packaging.

If you would like to know how we execute these six steps in a project, please visit our page on CE marking.

How to know when a step is complete

Most delays occur because a step is only half-finished yet the process continues. A step is complete when you can demonstrate the outcome to an outsider in a document that refers back to the previous step. If you cannot do that, the step is not finished.

• Step 1 is complete when you can name the applicable acts by title and number and explain why others do not apply.
• Step 2 is complete when you know for each requirement which standard covers it and whether you are applying that standard in full.
• Step 3 is complete when the risk assessment links every identified source of risk to a measure.
• Step 4 is complete when the report provides a result for each tested clause and the type number is correct.
• Step 5 is complete when someone unfamiliar with the product can follow your file.
• Step 6 is complete when the declaration mentions all applicable legislation and the marking meets the formal requirements.

Why the sequence matters

The steps build upon each other. Your choice of standards follows from the legislation, your test program follows from the standards, and your file follows from the tests. If you reverse this, you may be testing against standards that are not the correct ones. This will only become apparent during an inspection.

This often goes wrong when purchasing from a country outside the EU. The supplier provides a report. That report then becomes the starting point instead of the outcome. What you then have is a test without a scope.

The pitfalls we see most often

In the files we take over, the same five problems recur: an incomplete risk assessment, outdated test results, user documentation in the wrong language, a marking that does not meet formal requirements, and unclear role distribution between parties in the chain.

• Too many model numbers on a single report. A report that claims to cover twenty variants without justifying why they are equivalent is difficult to defend during an inspection.
• Outdated standard references. References in the Official Journal are replaced, with a transition date. After that date, a report against the old version loses its validity.
• Manual in the wrong language. Safety instructions must be understandable to the user in the country where you are selling.
• Marking too small or distorted. The proportions are fixed and the height must be at least 5 mm when specific legislation does not specify a dimension.
• Relying on the supplier’s word. A supplier who says it is CE is saying that about their product in their context, not about your declaration.

Manufacturer, importer, or distributor

Your role determines your obligations. That role follows from what you do, not from what is in your contract. If you sell under your own brand, you are the manufacturer. If you bring a product from outside the EU into the market, you are the importer, even if you do not change anything about the product.

The marking is applied exclusively by the manufacturer or their authorized representative. If you are in a different role, your work is not about applying the marking but about verifying that what is already on it is correct.

What to do first

Start with one product and at step one. Document which legislation applies and why. That document is the foundation for everything that follows. Furthermore, it is the question on which most files fail. Then repeat this exercise for each product group.

1. Describe the product functionally: what it does, how it is powered, whether it communicates, and who it is intended for.
2. List the applicable acts alongside this with their numbers. Note why other acts do not apply.
3. Request the full test reports from your supplier, not just the conclusion page.
4. Compare the reports against your list of requirements and highlight what is not covered.
5. Only then determine which tests you still need to have performed.