Document ID: chunk:federal_register_of_legislation:F2021C01287:reg:1
Version: federal_register_of_legislation:F2021C01287
Segment Type: reg
Provision Reference: reg 1
Character Range: 16887–17936

1     a device other than a low risk device or a variant of a low risk device                                                                   (a) a description of the device; and
                                                                                                                                                (b) a declaration of conformity; and
                                                                                                                                                (c) a test report or a technical construction file; and
                                                                                                                                                (d) for a device to which a compliance label is not applied because of section 3.6—the records mentioned in subsection 3.6(3); and
                                                                                                                                                (e) a copy of any explanatory documentation required by section 3.7