Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:1_8
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 1 cl 8
Character Range: 61220–62466

8              a notified body within the meaning of the EU medical devices regulation    (a) for a medical device that the manufacturer intends to be supplied in a sterile state:                                                                                                                                           an EU type-examination certificate issued under Annex X of the EU medical devices regulation
                                                                                            (i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation;
                                                                                          (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following:
                                                                                            (i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or
                                                                                            (ii) an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation