The CE mark on a product indicates that the product meets European Union (EU) compliance requirements. Most products are required to bear the CE Mark to be sold in the EU. This includes medical products, toys, appliances, and machinery. But what exactly does a CE Mark mean? Unfortunately, understanding the exact meaning of a CE mark can be very confusing. All you know from looking at a CE mark is that the manufacturer believes the product complies with one or more of the CE Mark “Directives”.
CE Mark Confusion: The difficulty in understanding what a CE Mark on a product means is that a CE mark can mean many different things. The CE Mark system applies to a very large set of requirements covering many different fields of regulatory compliance, with some part of the CE Mark program applying to most products. Different requirements apply to different types of products meaning that no two CE marks are alike.
Identifying What a CE Mark Means: If you see a CE mark on a product, you really have no idea what it means. In order to know what a specific CE mark means, you must have a copy of the CE Declaration of Conformity (DoC) for the product. This document is required to be provided with any CE marked product. The CE DoC defines to what CE requirements the product complies. So you must refer to the CE DoC in order to know what the CE mark means on a specific product.
CE ≠ UL: A common misconception is that the CE mark is just like a UL mark and therefore it should be accepted in the United States. But the CE mark program is very different than the US-UL NRTL program and the CE mark is definitely not equivalent or suitable in the US.
- While the CE program includes product safety requirements that in many cases are similar or even harmonized with those in the UL standard, product safety is only one element of the CE program. CE consists of most of the areas of compliance including areas known in the United States as FCC, FDA, EPA, etc.
- Many of the CE requirements are “self-certification” meaning the manufacturer decides if they comply. Whereas the United States certification program is based on a 3rd party approval system where the product must be “certified” and bear the mark of an OSHA accredited NRTL lab such as Underwriters Laboratories, Intertek, CSA, or MET Labs.
- Because the manufacturer decides what CE requirements apply to their product, the manufacturer may leave out product safety in their CE mark review even if it is required = because there is no system to check the manufacturer’s work! Only for a few very high risk products is an EU “Notified Body is required to review that all CE requirements were properly applied and that the product truly complies.
CertifiGroup works with ALL CE Directives.
CertifiGroup KNOWS your CE options.
CertifiGroup can do all the CE work for you.
Or, CertifiGroup can help you do-it-yourself.