Steps to Take When Placing a CE Marking for Your Product
CE marking on a product is a manufacturer’s declaration that the product conforms with all the legal health, safety, and environmental requirements. Check out last week’s text on how to know if you need CE Marking for your product(s). In the text, you’ll find enough information about why it’s important, the products that need CE Marking, and the countries where you’ll need to affix CE-mark for your product. Which brings us to today’s topic: 6 steps to take to obtain CE Marking for your product. Please read on.
1. Identify the Harmonised Standards and Directives to Your Product
There are about 24 directives covering different product categories that require CE Marking. You need to check if your product falls under one of the directives. If yes, consider putting CE mark to the product. You should also consider the Harmonised European standards that express the essential safety requirements for the production and use of your product. These standards are usually issued with reference to the 20+ directives available.
2. Check the Specific Requirements of the Product
Each directive clearly explains the essential requirements you need to achieve conformity of your product. However, these requirements are not specific in nature; the directives don’t detail how the product in question should be designed to meet the requirements. Making sure your product complies with the relevant EU legislation requirements is all up to you. Applying the harmonised standards in your conformity assessment is also voluntary. The most important thing when you don’t use the standards and directives is to provide relevant documentation showing that your product(s) is safe.
3. Determine if You Need Third-Party Assessment
There are conformity assessment bodies, also known as Notified Bodies (NB), who usually test and certify certain products if the directives demand so. If a particular directive does not require the use of an NB, you’ll be free to proceed with self-certification. Since this doesn’t apply to all products, it’s important to check and confirm to make the necessary arrangements with the authorised NBs.
4. Product Testing and Conformity Check
As a manufacturer, you’re responsible for testing your product and checking for its conformity to the relevant EU legislation. There’s a procedure to follow during this step - the conformity assessment procedure, which can involve parts like risk assessment. In this step, you’ll apply the relevant directives and harmonised standards, and you’ll have conformed to the essential requirements.
5. Create and Maintain Technical Documentation
When you manufacture your product, it’s your responsibility to create the technical documentation as per the directive(s)’ requirement. This will include information about the risk assessment and the assessment of your product’s conformity to the relevant EU legislation. You’ll have to present the EC Declaration of Conformity (DoC) and technical documentation to the relevant authorities in the country, upon request.
6. Declaration of Conformity and Placing the CE Mark on the Product
DoC document acknowledges that you’re responsible for the compliance of your product with the relevant directives. This document should be made available to the relevant authorities at the EU point of entry and the EU distributors. When placing the CE mark, ensure that it’s legible, visible, impossible to remove and that it follows its legal format. In case you used an NB, ensure to display its identification number.
You’ll then sign an EC DoC to prove that your product meets the essential requirements. What’s next? Well, the market awaits for your CE-marked fabrications. All the best!