scope:

This standard specifies requirements on information to be supplied by a manufacturer for different categories of medical devices, as required by the relevant EU Directives. It does not specify the lanquage to be used for such information. It is intended to complement the specific requirements of the EU Directives on medical devices in the context of specifying means by which certain requirements can be met. If these means are followed by a manufacturer, they will provide presumption of conformity with the relevant essential requirements regarding information to be supplied.