If the Dutch enforcement body finds your product does not meet CE marking requirements, it may take legal action against your company, warehouses and distributors. You may or may not get the opportunity from the Dutch enforcement body to ensure it is correctly CE marked. If you fail to comply with CE marking regulation, your products may be seized and you will be obliged by the Dutch authority to take your product off the market. You may also be liable for a fine or other sanctions from the Dutch law enforcement body. Please contact Dutch lawyer Mark van Weeren if you have any questions on CE Marking enforcement in the Netherlands.
CE certification rules in the Netherlands
The manufacturer, has the responsibility to perform a CE certification conformity assessment, prepare a technical file, draw up the conformity declaration and apply the CE marking to the product. When you apply the CE marking, you are declaring that your product has been tested and meets all of the European directives that apply in the areas of safety, health and the environment. Product groups that require CE marking include machines, gas devices, pressure equipment, medical aid devices, personal protective equipment, medical devices, building products, electrical equipment, electronic equipment, recreational craft, and toys.
Responsibilities on CE certification
If you are a manufacturer who sells a product within the EU it is your responsibility to:
- carry out the conformity assessment for CE certification
- set up the technical file
- issue the EC Declaration of Conformity (DoC) –
- place CE marking on a product If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.
If you are importing a product in the Netherlands that is from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available.
Law requires CE marking on certain products
The directive on CE marking prescribes that the manufacturer should have certain, not all, products tested by a competent inspection body known as a Notified Body (NoBo). The EU has appointed Kiwa as a NoBo. This means that Kiwa is entitled to issue CE marking for items such as building products, pressure vessels and gas devices. CE marking for medical devices is designated to e.g. BSI, SGS, TUV and others. For further reading also check this Dutch government information on CE-marking.
Product assessment by notified body
Sellers and manufacturers should check if the product has to be tested by a notified body. You can find this information in the relevant legislation applicable to the product: check the rules by product category. This independent assessment is not obligatory for all products. But do check this.
If you need a notified body for the product assessment, the CE marking must be accompanied by the identification number of the notified body. The CE mark and the identification number can be affixed separately, as long as they appear clearly linked to each other. In the Nando database you can search for a notified body that can certify your product.
Medical devices and CE marking
A medical device is any instrument, apparatus or appliance that is used to diagnose, monitor or treat a disease, injury or handicap in humans. The term “medical device” applies to a broad range of products, devices and equipment, from simple tongue depressors and bedpans to laser surgical devices. Medical devices should not be confused with other classes of products used to treat medical conditions. For example, medications and pharmaceutical preparations. Check out the Dutch version on CE certificates in the Netherlands: handhaving inspectie CE markering.
The attorneys of Blenheim are happy to assist you with any CE Marking issues.