Certification in Europe - The CE Marking
What is a CE Marking?
CE Marking is often referred to as a 'passport' that allows manufacturers from anywhere in the world to sell their goods throughout the European market. When a European "New Approach Directive" is in force for a certain product, all European Union Member States will legally require a CE Marking on the product, packaging or accompanying literature.
In all cases, it is the manufacturer's responsibility to ensure that their products comply with the essential requirements of any and all Directives that cover it.
TÜV SÜD Canada can help you achieve CE Marking efficiently and cost effectively. At TÜV SÜD Canada, we have a team of experts who understand exactly what each Directive requires for each product, so that you don't have to. We are able to provide testing and product evaluations to the appropriate standards and requirements, and we have access to European Notified Bodies for those categories where verification of testing and quality assurance is required under the Directive.
The CE marking itself consists of the stylized letters "CE" shown. Any product that bears this marking is presumed to comply with the appropriate European technical requirements and documentation procedures as prescribed by the Directives.
What are "New Approach Directives"?
New Approach Directives are rules covering product design and manufacturing for most manufactured goods intended for the European market. They are intended to ensure safety and seek to harmonize technical requirements allowing the free movement of goods throughout Europe.
The directives cover a very wide range of product areas including toys, medical devices and pressure equipment.
CE marking requirements vary from Directive to Directive, and even within Directives. Third party testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturer's self-declaration of conformity is all that is necessary. But beware! If you claim your product complies and it doesn't, you are in violation of European law.
Where a Directive requires products and/or systems to be independently tested, certified, or inspected, this must be done by a "Notified Body" or "Competent Body".
What is a Notified Body?
The primary role of a Notified Body is to provide services for conformity assessment on the conditions set out in the New Approach Directives in support of CE marking. This normally means assessing the manufacturers conformity to the essential requirements listed in each directive. Most Directives allow the manufacturer to self-declare conformity, however some products, such as certain types of medical devices, machinery, pressure equipment, etc. do require Notified Body involvement. In these cases, conformity assessment can be inspection, quality assurance, type examination or design examination, or a combination of these.
Although there are no Notified Bodies outside of Europe, TÜV SÜD Canada is an established Notified Body for third-party verification or quality assurance is required by the Directive. For any product, we can determine whether or not Notified Body involvement is necessary, and we can help you achieve Notified body certification quickly and efficiently.
What is the Procedure for Applying a CE Marking to my Product?
TÜV SÜD Canada can determine the route to compliance that is most appropriate to your needs and help you through the CE Marking Process easily and cost effectively.
For details on the Steps Every Manufacturer Needs to Follow to apply for CE Marking, click here.
We can help you.
TÜV SÜD Canada has a wealth of experience in achieving compliance to the European Directives.
We will assist you through all of the steps outlined and work with you to ensure that your product is in full compliance and has all the necessary documentation for the application of the CE marking.
Contact us today to begin the CE marking process for your product.