Document ID: chunk:federal_register_of_legislation:F2025C00024:schedule:3
Version: federal_register_of_legislation:F2025C00024
Segment Type: schedule
Provision Reference: sch 3
Character Range: 90685–91480

Schedule 3—Medical devices used for a special purpose that are a system or procedure pack
Note: See section 7.

Part 1—All medical devices used for a special purpose that are a system or procedure pack

Division 1—System or procedure packs that are Class I medical devices intended to be supplied in a non-sterile state and that do not have a measuring function, Class 1 IVD medical devices, or intended for export only

Column 1  Column 2                          Column 3                                                                                                Column 4

Item      Regulatory authority              Declaration of conformity in relation to the system or procedures pack                                  Conformity assessment document in relation to each medical device