Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:3_8
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 3 cl 8
Character Range: 26500–27531

8  Alternative kinds of information
 Medical devices other than IVD medical devices
(1) An application for a medical device other than an IVD medical device may be accompanied by the kind of information determined under section 5 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned, rather than the kind of information determined for that class of medical device under that section.
 IVD medical devices
(2) An application for an IVD medical device may be accompanied by the kind of information determined under section 6 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned, rather than the kind of information determined for that class of medical device under that section.
Note:  The kind of information determined under sections 5 and 6 relate to the minimum conformity assessment procedures that the manufacturer must apply to a kind of device of that classification.