Division 3

The documentation must allow an understanding of the design, the manufacture and the performances of the device. The documentation shall contain the following items in particular:

• a general description of the type, including any variants planned,

• all documentation referred to in Annex III, section 3, indents 3 to 13,

• in the case of devices for self testing, the information referred to in Annex III, section 6.1.