Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:3aa_2
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 3AA cl 2
Character Range: 453022–453825

2  EU Regulations
 (1) The requirements are:
 (a) to the extent the determination covers medical devices that are not IVD medical devices—the requirements of the EU medical devices regulation, as modified by clauses 3, 4 and 5 of this Schedule; and
 (b) to the extent the determination covers IVD medical devices—the requirements of the EU IVD regulation, as modified by clauses 3, 4 and 6 of this Schedule.
 (2) The EU medical devices regulation is Annex VII to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force from time to time.
 (3) The EU IVD regulation is Annex VII to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force from time to time.