When is CE marking mandatory?

The rule in one sentence

The marking is mandatory when a European harmonisation act prescribes it for your product type. There is no general CE obligation for all products. Nor is there a free choice. The answer follows from the legislation applicable to your product.

This effectively turns the question ‘when is it mandatory’ into the question ‘under which legislation does my product fall’. You answer that second question by looking at what the product is and what it does: how it is powered, whether it communicates, who it is intended for, and in what environment it is used.

A product can fall under multiple acts simultaneously. A toy robot with a battery and an app involves toy legislation, radio regulations, the battery regulation, and chemical substance legislation. One marking then covers them all, provided your declaration also lists them all.

Which products are covered

The best-known categories are toys, machinery, electrical equipment, radio equipment, personal protective equipment, medical devices, construction products, pressure equipment, and lifts. Each category has its own act with its own requirements and assessment route. The table below lists these acts per category.

This list is not exhaustive. Measuring and weighing equipment, pressure equipment, lifts, ATEX equipment, and recreational craft each have their own act. If in doubt, start with the category where the product functionally fits and work back from there.

When the marking is prohibited

This is the other half of the rule and it is rarely mentioned. The CE marking is only affixed to products for which harmonisation legislation prescribes it and to no other product. A marking on a product that is not covered is therefore a violation in itself.

In practice, we see this mainly with webshops that use the marking as a form of reassurance. A wooden cutting board, a bag, or a piece of clothing does not fall under a CE act. If you affix a marking anyway, you mislead the buyer and violate the rules.

Such products generally fall under the General Product Safety Regulation. This sets requirements for safety, documentation, and information, but does not involve a marking. No CE, therefore, but still obligations.

When you legally become a manufacturer

Your role follows from what you do, not from what is stated on the invoice. If you sell a product under your own brand name, you are generally identified as the manufacturer. The same applies when you modify an existing product in such a way that compliance may change.

For e-commerce, this is the most important point of this article. Anyone who has a product manufactured in Asia with their own logo on it is not just buying stock, but also a set of obligations. During an inspection, you cannot point to the producer, as they do not sell to the European consumer. You do.

If you import without your own brand, you are an importer. You also have obligations in that case. You must then check whether the manufacturer has completed the process. You also verify whether the documentation exists and whether the marking is correctly placed on the product.

CE certification does not exist

The term ‘CE certificate’ is widely used, but there is no body that issues ‘CE’. What does exist is a certificate from a notified body for a specific assessment procedure. This is different from the marking itself, which the manufacturer affixes.

For some products, such a body is mandatory. For a large portion, it is not: there, the manufacturer assesses themselves, provided they do so demonstrably and according to the prescribed procedure. Which route applies is stated in the annexes of the applicable act.

If you receive a document from a supplier with ‘CE certificate’ on it, check who issued it and for what purpose. Often it turns out to be a test report from a laboratory, which is useful but signifies something else.

What happens if things are not correct

The regulator can prohibit or restrict sales, have the product withdrawn from the market, or demand a recall. In addition, they can impose sanctions. When selling via a trading platform, your offer can be removed by order, with an execution period of two working days.

Furthermore, there is a financial risk that is often forgotten. If your product causes damage and is found not to meet the requirements, your insurer may refuse coverage. Personal injury or property damage will then be at your own expense.

How to determine it for your product

Describe the product functionally and compare it with the possible acts. If you find none, check whether it falls under the General Product Safety Regulation. Record the outcome in writing, including the reason why an act does or does not apply.

1. Describe what the product does, how it is powered, and for which user it is intended.
2. Go through the categories in the table and note which ones fit.
3. Check whether a radio function, a battery, or packaging is involved. These bring their own legislation.
4. Determine your role: manufacturer, importer, or distributor. If you sell under your own brand, you are the former.
5. Record the conclusion in a single document, with the reason for each act. That document is the start of your file.