The responsibility for product compliance with CE marking requirements lies with the manufacturer. However, when the manufacturer is located outside of the European Union, and did not comply with the requirements and procedures, the importer can be held accountable. In the new rules that have been introduced in 2008, the importer has the obligation to “ensure” the product compliance. This means that the importer must have the knowledge about the applicable rules and procedures. It also means that the importer must actively check the documentation, as well as the product. Importers that place on the market non-compliant products may be prosecuted. What can importers do to comply with their legal obligation to check product conformity? What means does the importer have to detect possible non-compliance? Join our FREE Webinar, CE Marking: How You Can Check If Suppliers’ Products Comply on the 13th of March 2014 at 16:00 (GMT+01).
The French Notified Body ANSM (The National Security Agency of Medicines and Health Products) recommended breast implants produced by Cereplas to be recalled from the European market.
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.