Frequently Asked Questions About CE

A European Directive can be regarded as an European law, and - unlike it's name may assume - is legally binding for every Member State of the European Union. Through transposition into the national legislation of the Member States, persons and companies are subject to the requirements of the European Directives.

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.

What to look for in a notified body

Once it is determined that you manufacture a product that is not subject to the self-certification route, the best way to proceed is to contact a notified body whose qualifications match up with your product, and whose credentials and affiliations match up with your and your target markets. After that there are a number of variables to consider.

• Price - Obtain quotes from at least a few notified bodies; pricing can vary dramatically.
• Service - Many notified bodies do not provide adequate service; usually due to peak load situations, lengthy European vacations and some simply disregard customer needs.
• Consulting - Some notified bodies will (and some will not) offer advice in addition to testing to accelerate the process and simplify the process for you (such as a desk audit of your technical documentation prior to actual submission).
• ISO 9000 and Product Certification - Very convenient and economical (when both are required) if a notified body can provide both services.
• Documentation - Find a notified body that will accept documents in English. Copyright 2007
• Mutual Recognition - Look for a notified body that will accept ISO 9000 registration from a U.S. registrar to avoid duplicate costs; also, find a notified body that will consider using qualified U.S. based subcontractors for audits to reduce travel related expenses.

If you can't find a Notified Body who will comply with the items listed above, keep looking, they do exist.

Does your product require CE Marking?

How do you acquire CE Marking?

There are a series of steps outlined below. Depending upon your product and the nature of the risks it presents, there are several alternatives also noted that may apply to your situation.

• Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
• Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
• Choose the conformity assessment procedure from the options called out by the directive for your product.

The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.

Options for products with minimal risk include self certification where the manufacturer prepares a declaration of conformity and affixes the CE Marking to their own product.

Options for products with greater risks can require tests, audits or additional certificates from a notified body.

• Select the applicable product standards and test methods for your product and select an independent lab If the product testing is to be done externally.
• Establish an authorized representative for regulatory affairs in the European Union for your product. Some directives require that a manufacturer designate in Europe a representative to produce technical documentation in a timely fashion when called upon to do so.

The directives require for many products that a technical file be prepared by the manufacturer. The technical file holds information that verifies that the testing was conducted properly and that the product complies with applicable standards.

• Prepare a declaration of conformity that includes a list of the directives and standards that your product conforms to; product identification, the manufacturer's name, address and signature.The declaration of conformity contains information adequate for tracing the product back to the manufacturer or the authorized representative in the European Union.
• Affix the CE Marking to your product. There are specific rules to adhere to in CE Marking. These rules address the size and location of the marking, affixing the CE Marking to products, packaging and material or documents shipped with the product, and specific limitations on when and who is permitted to affix the CE Marking.

Who's going to enforce the requirement for CE Marking?

Each member state of the European Union is bound to adopt into their National Law, regulations and administrative provisions to ensure that products placed on the market are safe. Each country has its own way of handling enforcement.