If you intend to market your product in Europe, you must make sure it meets all applicable laws and requirements, including CE Marking (also called CE certification). Determining whether your item requires a CE Marking, and certifying it against European laws and regulations, is a complex process.
What is CE Marking?
The Conformité Européenne, or CE Marking, is a symbol that shows an item complies with the European laws governing health, safety, and environmental protection.
Unlike other certification marks that are applied to an item once it passes tests administered by a particular organization, no group grants permission to use a CE Marking. As a manufacturer, it is your responsibility to understand and comply with European law and use the CE Marking if necessary.
It is illegal to affix a CE Marking improperly or to use it on an item that does not require a CE marking. Learn more about CE Marking.
The CE Marking and Routes to Compliance
The process for CE certification includes identifying which Directive(s) and Regulations pertain to your product, completing conformity assessment, setting up a Technical File, and signing a Declaration of Conformity. After completing these steps, you can legally put the CE Marking on your item.
First, identify which European Product Laws are relevant to your product. There are over 20 CE Directives and Regulations, covering a spectrum of products, from electrical equipment to machines to toys to PPE. An item may fall under more than one law.
Next is the conformity assessment, which may be carried out either in-house or by an authorized certification organization known as a Notified Body. The certification proves your product satisfies European laws, and the assessment documents become part of your Technical File. You need to be able to produce your Technical File for EU Authorities upon request.
Then, you must sign a Declaration of Conformity affirming that your item meets all applicable EU laws.
Once you’ve completed all the steps above, your product can legally display the CE Marking.
Choosing Technology International
Navigating the CE Marking process on your own can be intimidating, especially when the penalties for non-compliance include product recalls, fines, and jail sentences.
Unless you are familiar with the EU legislation, it can be challenging to determine which laws apply to your product. You need to be aware of all revisions, changes, and amendments, and there is very little accompanying reference material or specific guidance.
At Technology International, we’ve been providing CE Marking and compliance support for over 30 years, enabling over 10,000 different types of products/equipment to reach the European market. Based in the US, we specialize in supporting manufacturers across North America as they expand their business into Europe.
We offer expert guidance and support throughout the CE Marking process, from identifying which Directives and Regulations apply to your item, to helping you assemble a complete Technical File. As an accredited Notified Body, Technology International is highly qualified to assess product conformity.
Our CE Marking services include:
- Determination and selection of applicable Directives and Regulations
- Inspections, risk assessments, testing (typically at your facility)
- Notified Body EU Type Examinations
- Compilation of Technical Files and other documentation
- Regulatory consulting
With expert support from Technology International, there’s no reason for complex CE Marking requirements to hold your business back.