Is CE marking mandatory?
CE marking is mandatory for certain products sold in the European Economic Area (EEA). The EEA includes the member states of the EU, members of the EFTA (including Switzerland), and Turkey. The United Kingdom will continue to accept the CE mark until the end of the Brexit transition period. For more information on the countries for which CE marking is mandatory, click here.
What products need to be CE marked?
Products which require the CE mark are those that fall under one or more of the European Commission product directives, also known as the New Approach Directives. This includes (but is not limited to):
- Electrical equipment
- Medical devices (including active implantable MDs and in vitro diagnostics)
- Construction products
- Personal protective equipment
- Pressure equipment
- Radio equipment
- Gas appliances
- Simple pressure vessels
Often, a product is subject to more than one EU requirement. In that case, the manufacturer must make sure that the product complies with all relevant requirements before affixing the CE mark. It is illegal to affix the CE mark to products that do not fall under the scope of EU Directives.
How long does it take to get my product CE marked?
On average, the CE marking process takes four to six weeks, but it can also take longer or shorter based on how prepared the manufacturer is with their technical file and the required conformity assessments.
The most important factors that determine how long CE marking will take are the type of product and the extent to which it complies with the applicable directives. Sometimes, a product will need to be modified in order to meet certain directives. In other cases, a third party will need to perform an on-site test to determine the safety of the product.
However, since the certification process is different for every product, it is difficult to determine how long CE marking procedures will take without having an overview of the product design and the required technical documentation. To learn more about the CE marking process, click here.
How much does CE marking cost?
There is no specific answer as to how much CE marking costs. Costs are determined by which certification procedures apply to the product, whether the product requires testing, and whether a third party is involved (to carry out assessments and/or to give support throughout the CE marking process).
If you (the manufacturer) assess the conformity of your products yourself and your product does not require any testing, you do not have to pay fees to affix the CE mark. However, a lot of products require testing by a third party. Many manufacturers also choose to work with a third party to simplify the certification process: it saves time and ensures the quality and safety of a product.
If you are unsure whether to apply the CE mark yourself or to work with a third party, read more about self-certification here. You can also contact us to request a free offer and get an overview of the procedure and the costs involved. In short: the costs of CE marking vary per product, since it depends on the certification procedure and the complexity of the product.
How do I get my product CE certified if my company is not based in the EU?
The process for applying the CE mark is the same whether your company is based in the EU or not:
- Identify the EU directives relevant for your product
- Check if your product meets the requirements and needs to be tested
- Compile the technical documentation
- Affix the CE mark and draft the declaration of conformity
- Certification is complete: your product is ready for trade in the EU
However, manufacturers based outside of the European Union must have an authorised representative (AR) to sell their products on the EU single market. The AR does not certify the products, but reviews the documentation provided by the manufacturer and evaluates the certification procedures and safety of the products so that it can be sold within the EU.