CE Marking process

CE Mark Within Intertek Group there are four European Union-based Notified Bodies located in Germany, Sweden, and two in the United Kingdom. Before your products can be placed on the European market they must meet the requirements of relevant product directives. Intertek can guide you through all steps of the CE Marking process, from preparing your technical file and declaration of conformity to developing a monitoring and reporting system.

Obtaining the CE Mark Before the CE Mark may be affixed to a product and legally sold within the European Union, the manufacturer or exporter must complete the following: Prepare Technical Documentation (Technical File) to show the product’s compliance with applicable essential requirements and conformity assessment procedures of the applicable device directive. Prepare a "declaration of conformity" which means that you, as a manufacturer, declare that your product fulfills the requirements of the applicable directive. According to some directives you must also receive a product-specific CE marking certificate from a Notified Body. Navigating the CE marking process does not have to be complicated. In fact, Intertek makes getting a CE mark as easy as the following steps: 1. Determine which directive is applicable to your product 2. Fulfill the essential requirements - Ensure that your product fulfills the essential requirements of the relevant product directive. 3. Establish a monitoring system - As a manufacturer, you are required to monitor your products once they are on the market, in case necessary updates must be made in accordance with updated standards or international requirements. 4. Establish an accident reporting system - If an accident or near-accident involving any of your products takes place, you are obliged to report this to appropriate authorities. 5. Issue a Declaration of Conformity 6. Save the documentation for five years - Declaration of conformity, technical documentation, reports, and certificates from the Notified Body etc. must be kept for at least five years after the product has been taken out of production. 7. Register with the appropriate governing body within Europe

SOURCE