What is the difference between USA compliance and CE?
A manufacturer in the EU can utilize European harmonized standards to comply with the relevant requirements of the CE marking directives for a particular product to affix CE marking.
However, in the United States, there is no standardized law that has been put in place when it comes to placing the product on the market. Both mandatory standards and voluntary standards cover applicable requirements for the products.
Just like the EU, products in the US are also categorized under regulated and non-regulated products. However, after which essential procedures and analysis they are being placed on the market varies greatly. It is therefore crucial to be aware of the differences between USA compliance and CE.
|Starting with the most important difference between the USA compliance and CE; the USA compliance marking is not a legal obligation.||CE marking on a product is mandatory to prove it meets the fundamental legal requirements of the relevant Directive before it is placed on the market.|
|The manufacturer in the US can bring the products out in the market without any USA compliance marking.||If there is no need for CE marking, the General Product Safety Directive (2001/95/EC) may apply.|
|In the US, every state has its own liability law according to its own standards as sanctioned by the congress.||Every new Directive in the EU is designed from scratch and is applicable throughout, irrespective of the state.|
|In the US, you are required to file a report for dangerous and defective products, but that doesn’t mean they wouldn’t get placed on the market as they are not banned.||The EU has the General Product Safety Directive 2011/95/EC (GPSD) in place for non-regulated consumer products before they become available to the masses.|
|The product safety requirements designing and the compliance inspection are done by the same federal agency.||The European Commission is involved in the designing process and the national authorities complete the inspection process.|
Still unsure about the differences between USA compliance and CE marking? Our experts are happy to help. Whether you’re a manufacturer in the U.S. or EU, we can help you perform the entire certification process to ensure that your products meet the specified safety requirements.
- CE Marking
- Certification Experts
- Authorized Representative
- CE Declaration of Conformity
- Competent Body (Notified Body)
- Technical File
- Information on the Product
- USA compliance
- Self certification
- Export to China
- Summary Directives
- Medical Devices