Document ID: chunk:federal_register_of_legislation:F2025C00024:clause:2_5
Version: federal_register_of_legislation:F2025C00024
Segment Type: clause
Provision Reference: sch 2 cl 5
Character Range: 75823–77805

5              a notified body within the meaning of the EU IVD regulation                                                an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation                                                                                                                               one of the following:
                                                                                                                                                                                                                                                                                                                                                                  (a) for an IVD medical device for self‑testing or an IVD medical device for point of care testing—an assessment of technical documentation set out in section 5.1 of Annex IX of the EU IVD regulation; or
                                                                                                                                                                                                                                                                                                                                                                  (b) for an IVD companion diagnostic—an assessment of technical documentation set out in section 5.2 of Annex IX of the EU IVD regulation; or
                                                                                                                                                                                                                                                                                                                                                                  (c) for other IVD medical devices—the assessment of technical documentation as set out in section 4 of Annex IX of the EU IVD regulation for at least one representative device in a generic device group