On Saturday 29 March 2014, the European Commission has published the recasts of eight CE marking directives. These directives are aligned with the rules and responsibilities for CE marking that were published earlier in Decision 768/2008/EU. These eight directives get new numbers. Read More
Often when you buy products or components to be used in your products, they bear the CE marking and the supplier indicates that they are in compliance with European directives and standards. For your company it can be important to receive CE compliant products or components, because you may bear the end responsibility for these products. Perhaps because your company resells these products in the European market under its own brand name. Or perhaps because your company incorporates the product/component in its own product. Read More
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. Do you trust your supplier enough to sign and take responsibility for his products?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). Read More
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? Read More
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. Read More