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 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
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.
On Friday 4 May 2012, the European Commission published an updated list of the European harmonized standards that pertain to the ATEX Directive (94/9/EC), the European CE directive that applies to equipment used in potentially explosive atmospheres. The standards on this list may be used by manufacturers to prove that their equipment complies with the essential requirements of this directive. The list introduces two new European harmonized standards: 1. EN 13617-2:2012 Petrol filling stations – Part 2: Safety requirements for construction and performance of safe breaks for use on metering pumps and dispensers. This standard replaces the 2004 version with the same number. By 30 September of 2012 the new standard must be applied in order to keep benefiting the presumption of conformity. 2. EN 60079-11:2012 Explosive atmospheres – Part 11: Equipment protection by intrinsic safety ‘i’ (IEC 60079-11:2011). This standard replaces the EN 60079-11:2007 + EN 60079-27:2008 + EN 61241-11:2006. By 4 August of 2014 the new standard must be applied in order to keep benefiting the presumption of conformity. This updated list is also important to all manufacturers of CE marked ATEX that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directive, we recommend you to check the new list of standards to see if any of the standard you applied have been updated, or whether there are new standards available for your products. When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity. The updated list of standards can be found in our Library shortly.
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.