KNOWLEDGE BASE CE Marking In The Netherlands
CE Marking In The Netherlands
CE marking is an important part of taking a product into the Netherlands and anywhere in the EU. Many companies are interested in learning whether their product requires CE marking, how best to get CE marking, how long it takes, and how costly it is. The best answer we can provide is that the answers depend on a number of variables because each product is different. We can, however, help you understand the overall process, including what variables are involved in CE marking, and point you toward more information.
What is CE marking?
CE Marking is an important part of taking a physical product into the Netherlands and anywhere in the European Union (EU). CE marking (Conformité Européenne ((European Conformity)) is a physical goods manufacturer’s declaration that a product meets the requirements of the applicable European Commission (EC) directives. Basically, CE marking allows goods to move within the European market. CE marking shows that manufacturers have confirmed that their products meet EU safety, health and/or environment requirements, that they have complied with EU legislation, and that their product is able to freely trade within the single market. By placing CE marking on a product, a manufacturer is declaring its products conform to CE marking legal requirements.
GET PROFESSIONAL HELP! We strongly suggest that you seek expert assistance in applying for and obtaining CE marking. There are a limited number of companies that are approved to assist you with CE marking, the list is available here.
You can also find other firms to assist you on the United States’ export.gov page for CE Marking - Consultants/Ordering Standards. Export.gov recommends experts that work throughout the United States (by state) and Europe (by country).
What laws and regulations apply?
CE marking requirements are product specific, and are laid out in directives on those different products and product sectors. If harmonised European standards exist for your product and you follow them in your production process, your product will be presumed to be in conformity with the requirements laid down in the relevant EU directives.
To Whom and what does CE marking apply?
CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to medical devices. Today, CE marking is required on many products traded within the single market for the European Economic Area (EEA). If you are interested in engaging in trade within the EEA, you will need to conform to this regulation if your product requires it. A list of products that require a CE mark can be found online.
How do I comply with CE marking requirements?
In order to prepare your testing and declaration of conformity, it’s important to have a standard against which your product will be measured. The standard created by the EU is called a harmonized standard developed by recognized European Standards Organizations, such as CEN, CENELEC, or ETSI. Manufacturers or conformity testing agencies will use harmonized standards to demonstrate that products, services, or processes comply with the appropriate EU legislations. A full list of harmonised and other standards for goods is available here.
CE marking process
The price and time required to qualify for CE marking will depend on what procedures apply to your product, which is determined by how your product is intended to be used, the specific standards that apply to the directive your product falls under, whether you can do some or all of the conformity assessments yourself, whether the category you are applying for requires third party assessments, the level of support you will need if assistance is desired or required for the compliance documentation, and whether you are able to provide acceptable technical specifications, user manuals and product labeling. Below is a brief explanation of the six-step process to CE marking.
1. Identify the EU requirements (applicable directive) for your product(s).
There are 20 different categories of directives. It is important that you select the directive that is appropriate for the intended use of your product, since products can be covered by more than one CE directive. You should explore the listing of categories outlining each one, to identify which category your product best fits.
2. Check whether you product(s) meets the specific requirements.
In order to identify the certification requirements for your product, it is important to review the European Harmonised Standards, which are developed by recognized Standards Organizations, for that category.
3. Check whether your product must be tested by a Notified Body.
Many products do not require a conformity assessment from a notified body. This is where a lot of companies that are unclear about the requirements will spend unnecessary money leading to higher CE marking costs. Here is a list of companies that are approved as notified bodies. Often, and when the product category allows, the manufacturers can perform a conformity assessment themselves.
You may want to consider combining CE marking with other markings or certifications, including ENEC14, TUV, GS, NEMKO, DEMKO, SEMKO, among others, since some of the testing and certification bodies are licensed to do more than CE marking.
4. Test your product.
Depending on the product category, with appropriate documentation, you can, at times, test products in-house rather than use expensive third-party testing centers. While using harmonized standards is voluntary, it is recommended. You can assess your risk by comparing your testing results to the harmonized standards.
You will need to provide a Declaration of Conformity and some member states will require the document to be translated into their language. Here is a Declaration of Conformity Example. You can find International Testing Labs here.
One way to reduce the cost, complexity and time required for CE marking is to use components that already have CE marks and other certifications.
5. Compile the technical dossier.
All of the directives require that the technical documentation, also known as the technical dossier, provide all of the information necessary to demonstrate that the product conforms to the directives and required standards. Many of the directives provide examples of the data that must be included in the Technical File to prove compliance. Data include the product design, product manufacturing specifications, components and how to operate the product.
It is recommended that the Technical File be written in English, although you can use the language of the country in which you intend to file. You will also need to make the Technical File available for 10 years in most categories before you enter the market and the Technical File needs to be held within the EU. This means that if your office is not located in the EU, you will need to have a representative that you trust secure the information.
6. Affix the CE marking and draft a declaration of conformity.
You are not allowed to use the CE mark on any product that is not compliant with EU directives. By using the CE mark, the manufacturer takes full responsibility for compliance with the EU directives. The mark itself has format requirements, including visibility, legibility and permanence so it can’t be removed from the product or data plate.
In general, you should attach the CE marking to the product itself it at all possible but you are also able to attach it to the packaging and on literature such as manuals. Depending upon which directive your product fits into, there are different rules about how CE marking is allowed to be used.
Some general requirements include:
no CE marking is allowed to be used on products that doesn’t conform to the appropriate EU directives;
only you or an authorized representative can apply the CE mark;
you, as the manufacturer, take full responsibility for conforming to all applicable directives;
there must be no confusion or misrepresentation of what the CE mark means; and
no other markings or labeling can cover up the CE mark.
CE marking image requirements
Similar to style guides for company logos and images, there are specific guidelines to follow with the actual CE marking itself that are standardized.
all size changes must be in proportion to the standard
CE marking must be at least 5 millimeters in diameter unless a larger size is required for your products directive
the CE marking is placed on the product or data plate if possible or the packaging and supporting documentation such as manuals
the CE marking is permanent, easy to read and easily visible
For many companies with products that are not a safety risk, that are able to provide good technical documentation, and are compliant with appropriate EU directives, CE marking can be implemented quickly and cost effectively, often without requiring assistance from notified bodies or experienced agents.
If your company sells products in the Netherlands that require a CE mark, ensure your products are CE mark compliant before you begin doing business in the Netherlands. The CE mark process can be lengthy, so we recommend that you start early and get help when you need it.
KNOWLEDGE BASE CE Marking In The Netherlands