Document ID: chunk:federal_register_of_legislation:F2021C01287:reg:4
Version: federal_register_of_legislation:F2021C01287
Segment Type: reg
Provision Reference: reg 4
Character Range: 18465–19588

4     a variant of a device other than a low risk device                                                                                        (a) a description of the variant; and
                                                                                                                                                (b) a declaration of conformity that relates to the variant; and
                                                                                                                                                (c) a test report or a technical construction file for the original device; 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 statement by the supplier about the variant that is mentioned in subsection 4.7(2)