The European New Approach Directives form the starting point of the CE marking (Conformité Européenne). In these directives manuals are also discussed extensively. What do the European New Approach Directives mean and what do they mean for you and the manuals of your products?
When I set out to investigate this question, I would not have guessed that it would turn out to be as much of an odyssey as it did. For most products, determining the need for a CE Mark is relatively straightforward, but not for wire and cable products! As equipment designers, engineers and technologists, we rarely think much about wire and cable. We’re mostly concerned with the insulation colours, number of conductors, the gauge and the voltage rating. Sometimes we’re also concerned about the temperature rating, the flexibility, or perhaps the shielding. The regulatory approvals carried by the wire are often assumed, or not considered at all. This common product can bring a world of headaches if the requirements are not fully considered.
In order to understand the various types of EU Declarations, it’s important to first understand a bit about the system that uses them. Two systems of product safety evaluation are currently in wide use globally: Certification, and Marking. Understanding the differences between these two systems is important for anyone who gets involved with regulatory compliance activities. It’s also important to know that these Declarations have no relationship to the compliance declarations often used in commercial supply chains. Supply chain declarations are simply used to ensure that vendors attest to the fact that they supplied what the customer ordered. This type of document has no relationship to the EU Declarations discussed article.
After complying with the EU legislation, it is time to affix the CE marking. Where and how should the CE marking be placed? What are the requirements and who is responsible for affixing the marking? In which cases should you specify the identification number of the Notified Body that was involved in the conformity assessment procedure? Let’s take a look at the requirements of affixing the CE marking.
The compliance assessment procedure of certain products with the Europeans standards, as laid down in their corresponding EU directive, may involve the notification of third-party, independent bodies. In the EU, such organisations are called Notified Bodies and their role is to evaluate whether the product complies with the relevant legislation in force.1) In this article I will discuss what the role and responsibilities of a Notified Bodies are.
Basically, CE marking involves designing a product that meets relevant standards, building the Technical File and the Declaration of Conformity. The key is to know exactly which steps you need to take. All you need to do is demonstrate that you have fulfilled the essential requirements of any relevant directive. Also, you need to meet the relevant harmonized standards, and then produce the Declaration of Conformity and the Technical File. Finally, you can affix the CE mark on your product and start marketing it in the EU. Follow the flowchart below and your road to CE marking will be smooth and fast. To download the CE Marking Process Flowchart, click the icon below: Download