Scope of Part II
6. The requirements of this Part in respect of relevant devices apply in respect of medical devices (including stable derivatives devices), accessories to such devices, single-use combination products, and systems and procedure packs, other than—
(a)active implantable medical devices and accessories to such devices;
(b)in vitro diagnostic medical devices and accessories to such devices; and
(c)devices that come within the scope of Directive 93/42 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, and
(i)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it, and
(ii)the manufacturer chooses to follow the set of arrangements in the other Directive.