Is CE marking mandatory? We explain it briefly

What is CE marking?

CE stands for Conformité Européenne. It is a legally required marking for products covered by CE marking is a legally required designation for products covered by specific European directives and regulations. With CE marking, the responsible economic operator declares that the product complies with all applicable European safety, health and environmental protection requirements within the European Economic Area.

This is not a seal of approval or quality label. Instead, it is a legal declaration of conformity. The responsibility lies with the manufacturer or whoever is legally identified as the manufacturer.

Specifically, this includes:

• The product has been assessed according to relevant European legislation
• An appropriate conformity assessment procedure has been carried out
• A technical dossier has been prepared and is available
• An EU declaration of conformity has been signed
• The marking is correctly and visibly affixed

Thus, the marking is the final stage of a technical and legal process. Only when all steps have been completed correctly may the product be marketed.

CE marking and CE certification: what’s the difference?

The term ce certification is often used, but legally there is an important distinction. Marking itself is the declaration that a product complies with European legislation. Certification usually refers to a situation where an independent, designated body is involved in the assessment.

Sometimes a manufacturer may assess conformity itself. In other cases, such as certain medical devices or personal protective equipment, an external notified body is required to be involved. This depends entirely on the applicable directive or regulation.

In short, not every product requires external certification, but every product covered by CE legislation requires a demonstrable and correct conformity procedure.

When is CE marking Mandatory?

CE marking is required for several product categories, including toys, electrical equipment, medical devices, machinery, personal protective equipment, construction products and more. Each of these categories has its own specific guidelines and standards that must be met before a product can bear the CE mark. Depending on the category, the process for obtaining CE marking can vary, from self-certification to mandatory independent assessment by designated bodies. A good way to see if CE is mandatory is to use the RFO website. Through their easy system you will know in no time if you are required to have CE. This system can be found here.

Briefly, it applies to the following products, among others:

• Machinery
• Medical devices
• Construction Products
• Toys
• Personal protective equipment
• Electrical, electronic and energy related products
• Medical devices
• Measuring and weighing equipment
• Transportation Equipment

Each product category has its own requirements and assessment procedures.

For entrepreneurs sourcing products outside the EU, this is a critical issue. As soon as you sell a product under your own brand name or modify an existing product, there is a good chance that you will be legally seen as a manufacturer.

The same is true for many e-commerce sellers. If you sell a product with your brand on it, the responsibility shifts to you. You cannot then refer to a foreign supplier if something turns out to be wrong.

Why e-commerce sellers are at extra risk

Online sales increase visibility and, therefore, surveillance. Market supervisors conduct inspections based on reports, sampling and risk analysis.

Yet many sellers assume that a CE logo on the product is sufficient. However, it is not. Without access to the technical file and the EU declaration of conformity, there is no way to prove that the marking is legally valid.

Importers and brand owners are considered manufacturers in many situations. As a result, they are responsible for technical documentation, proper conformity assessment, product safety and possible claims, among other things.

What do you need to arrange for a valid CE mark?

The process for CE marking consists of several set steps. In outline, this process includes the following:

Step 1: Determine which directives and regulations apply
For each product, determine which European legislation it falls under.

Step 2: Establish essential requirements
Each directive contains essential health and safety requirements that the product must meet.

Step 3: Perform a risk analysis
Risks must be systematically identified and assessed. This forms the basis for technical measures.

Step 4: Apply harmonized standards
The use of European standards provides a presumption of conformity with the essential requirements.

Step 5: Conduct testing and assessments
Depending on the product category, this may be done internally or through an external body.

Step 6: Prepare a technical file
This file includes drawings, calculations, test results, risk analysis and operating instructions. It should be available to supervisors upon request.

Step 7: Prepare and sign the EU Declaration of Conformity
Hereby the responsible party declares that the product complies with the relevant legislation.

Step 8: Application of the CE marking
Only after completion of the above steps may the CE marking be visibly applied to the product.

The technical file must usually remain available for at least 10 years.

For a more detailed overview, please see our CE page.

Consequences of non-compliance with CE marking

When legal requirements are not met, the consequences can be significant. The Netherlands Food and Consumer Product Safety Authority oversees product safety within the Netherlands.

For violations, the regulator can impose sales bans, have products withdrawn from the market, require a recall, or impose administrative fines, among other things.

There is also an important financial risk involved. If a product causes damage and does not meet the requirements, an insurer may refuse coverage. In that case, personal injury or property damage will be borne entirely by the entrepreneur.

Especially with private label products, this can cause substantial financial and reputational damage.el can cause substantial financial and reputational damage.

Frequently asked questions about CE marking

When am I considered a manufacturer in CE marking?
You are generally considered a manufacturer when you sell a product under your own brand name, modify a product, or import a product from outside the EU and put it on the European market.

Is CE certification always mandatory?
No. External certification is mandatory only for specific product categories. In other cases, the manufacturer may conduct the conformity assessment itself, provided it is demonstrably and correctly done.

Is a CE logo from my supplier sufficient?
No. You must have the technical file and the EU declaration of conformity. Without these documents you cannot prove that the CE marking is legally valid.

How long should I keep documentation?
In most cases, at least 10 years after the product is placed on the market.

Need help with CE marking or CE certification?

Do you doubt whether your product is covered by CE marking? Or are you not sure if you are legally considered a manufacturer because you sell under your own brand?

If so, don’t wait for the NVWA to knock on the door or for a claim to arise. A correct approach to CE marking and possible CE certification starts with a good analysis of your product, your role in the chain and the applicable directives.

Instrux supports entrepreneurs and e-commerce sellers through the entire process:

• Determination of applicable legislation
• Conducting risk analyses
• Preparation of technical files
• Guidance on testing and conformity assessment
• Preparation of the EU declaration of conformity

Want certainty about your CE marking and liability position? Contact us and let us assess where you stand and what is needed to be compliant.