CE Marking
Does our product qualify for CE Marking if it has UL and/or CSA approval?
Often we get the question: Our product already has a UL and/or CSA approval. Does that mean that we can also automatically affix the CE Marking?
Unfortunately, that is often not the case.
There are differences between the CE marking certification process and the UL/CSA certification. And for that reason, normally compliance with UL/CSA does not automatically give the right to affix the CE marking. However, the UL/CSA certifications may make the CE process much easier when the testing and certification were conducted according to international standards similar to European harmonized standards relevant for the particular product. In that case, it may be possible to skip (parts of) the expensive product compliance testing.
Please note however that another part of the CE requirements is aimed at the manufacturer's ability to prove CE compliance through a Technical File. This Technical File needs to be compiled before the CE marking is affixed (it is a part of the approval), and even after the product has been placed on the market, the Technical File needs to be maintained and updated on a regular basis. The UL and CSA requirements for Technical Files are different, so this would require some attention from your side as well.
Whether the existing UL/CSA files may be used for proving CE compliance can be judged by our experts after a brief documentation review. We can also help you to determine the most cost effective route to CE certification of your products. Let us know when you are interested in our services.
Often we get the question: "Our product is not covered by any of the CE Marking Directive and does not require CE Marking. However our distributor in Europe insists in CE certification and the affixing of the CE Marking. What can we do?"
Our answer in such a case is as follows:
If your product is not within the field of application of any of the CE Marking Directives, it is not allowed to affix the CE Marking. If you would affix the CE Marking anyway, your company - and in case your company is located outside Europe - your European importers, would be liable to prosecution for false application of the CE.
In an effort to meet all regulations but not being fully informed about the details, sometimes distributors are insisting in having a CE Mark affixed to a product, even although it is not required. However, when it has been established that your product does not require CE, we recommend you to explain them that you are legally not allowed to meet their request.
Affixing of the CE Mark
The CE Marking must be affixed to the product, to its data plate or, where this is not possible or not warranted due to the nature of the product, to its packaging, if any, and to the accompanying documents by the manufacturer, the authorized representative in the European Community or, in exceptional cases, by those responsible for placing the product on the market.
The CE marking must be affixed visibly, legibly and indelibly. Where special provisions do not impose specific dimensions, it must have a height of at least 5 millimeters.
Steps for doing CE Marking
Step 1: Determine the applicable CE Marking Directives and harmonized standards
CEMarking product requirements and certification procedures are laid down in European Directives. There are currently approximately 25 CE Marking Directives for different product groups (e.g. machinery, toys, medical devices) or product aspects (e.g. electromagnetic compatibility). Please note also that more than one Directive can apply to a single product. For that reason, it is important to first identify which CE Marking Directives apply to a product.
Harmonized standards are standards, which are accepted by the European legislators as providing proof of compliance with the Directive(s) once the requirements of these harmonized standards are met. Therefore applying harmonized standards is the easiest way of proving compliance with the Directives requirements.
STEP 2: Conformity assessment
This step entails a product assessment against the applicable requirements from the Directives and standards identified during step 1. Conformity assessment may involve product testing, visual inspection, risk analysis, as well as a review of the product label and instructions. In some cases, but not in all cases, it is obligatory to have the conformity assessment performed/verified by a third party. This third party is referred to as 'Notified Body', or 'Competent Body'.
STEP 3: Documentation of product compliance
Every CE Directive requires the manufacturer or importer to compile and keep available for inspection a so-called Technical File. The purpose of the Technical File is to provide documented evidence of the product's compliance. Therefore the Technical File should contain at least all information about the product which allow the authorities to:
- identify the product
- determine the configuration of the product that was approved
- determine which standards were applied
- determine which directives were applied
- determine how the product meets the requirements of the relevant directives and standards
- identify the manufacturer and manufacturing process
- determine how the manufacturer ensures consistent quality of production and continuous product compliance
Which documentation exactly needs to be provided in the Technical File is stipulated in the text of the Directives.
STEP 4: Drawing up and signing the 'EC Declaration of Conformity'
Some CE Directives also require the Declaration of Conformity to be supplied together with the product.
STEP 5: Affixing the CE Mark (or other conformity marking)
In almost all cases the affixing of the CE Marking is obligatory. In rare cases, the CE Mark has to be accompanied by a 4-digit number of the Notified Body that was involved in the conformity assessment procedure. Please note also that some CE Directives no CE Mark is required, but completely different conformity marking (e.g. the ATEX Directive and the Marine Equipment Directive).
Please note that now it is also possible to register the CE marked product. In that case, a unique registration code is affixed next to the CE Mark.
STEP 6: Registration of CE Marking (Voluntary)
Although voluntary, we recommended registration of the CE Marked product.CE registration is done through the 'Foundation Identification and Registration Product Conformity' at http://www.ce-id.org. They will issue a registration number, a so-called CE-ID, which you will print on the label or packaging together with the CE Mark. Using the CE-ID, your customers can check the reliability and product compliance in the database on the website of CE-ID.