EU regulations on medical devices and on in vitro diagnostic medical devices include requirements and information provided by the manufacturer and on labeling of medical devices/in vitro diagnostic medical devices including their packaging. The following body is responsible for the drafting of standards in the field of terminology, labeling and symbols in order to specify the essential requirements specified in the EU directives.

In addition, there are product-specific specifications for terminology, labeling and symbols. These are anchored in the work programs of the corresponding technical committees.