scope:

This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.

This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).

NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.