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.
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.
Basically, CE marking involves designing a product that meets relevant
On Friday 27 April 2012, the European Commission published updated lists of the European harmonized standards that pertain to the Medical Devices Directive (93/42/EC), In Vitro Diagnostics Directive (98/79/EC), and the Active Implantable Medical Devices Directive (90/385/EEC). The standards on these lists may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive.
The updated list are important to all manufacturers of CE marked medical devices, active implantable medical devices and in vitro diagnostics that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directives, re-evaluate your products against the updated standards and update your Declaration of Conformity.
For the last 20 years, there has not been a single week in which I have not been asked the following:
“How much does CE marking cost?”
It is a very understandable question. I am sure that it is on your mind as well. Before you start the process of getting the CE marking, it is good to have an overview of the costs involved. But most people do not realize how difficult it is to answer this question.