The CE-marking indicates that a product complies with the requirements of the applicable European Directive(s). These Directives for products, which are called "New Approach" Directives, set out essential requirements which must be met before products may be marketed or traded within the European Economic Area. Thus, to indicate that a product complies with the applicable Directive(s), a CE-mark must be displayed.
Barda wil help to determine which European Directives and standards apply to their products, what the most efficient and cost-effective conformity assessment procedures are, as well as how to compile and maintain the Technical Files, which need to be kept available for the Notified Body.
