In the case of devices containing or a preparation which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant danger symbols and labelling requirements of Directive 67/548/EEC17 and Directive 88/379/EEC18 shall apply. Where there is insufficient space to put all the information on the device itself or on its label, the relevant danger symbols shall be put on the label and the other information required by those Directives shall be given in the instructions for use.

The provisions of the aforementioned Directives on the safety data sheet shall apply, unless all relevant information as appropriate is already made available by the instructions for use.