A manufacturer in the EU can utilize applicable European harmonized standards and/or Directives to in order to affix CE marking.

In the United States, however, there is no standardized law that has been put in place when it comes to placing a product on the market. Applicable requirements for a product can come in the form of both mandatory standards and voluntary standards.

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.

Compliance in the United States of America
USA compliance marking is not a legal obligation: the manufacturer can bring products onto the market without USA compliance marking.

Every state in the U.S.A. has its own liability law according to its own standards, as sanctioned by Congress. The drafting of product safety requirements and compliance inspection are carried out by the same federal agency.

You are required to file a report for dangerous and defective products, but that doesn’t mean they won’t get placed on the market as they are not banned.

Compliance in the European Union
Before it can be placed on the market, CE marking on a product is mandatory to prove that it meets the fundamental legal requirements of the relevant Directive(s).

If the product does not fall under the scope of the CE marking, the General Product Safety Directive 2001/95/EC (GPSD) may apply. The GPSD exists to ensure the safety of non-regulated consumer products before they become available to the masses.

Every new Directive is designed from scratch and is applicable throughout the EU, irrespective of the country. The European Commission drafts the Directives and 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.A or EU, we can help you perform the entire certification process to ensure that your products meet the specified safety requirements. Get in touch here.