Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:3aa_6:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 3AA cl 6 (pt 1/2)
Character Range: 465693–468513

6  Modifications of EU IVD regulations
 (1) For the purposes of subclause 2(1), the EU IVD regulation is taken to be modified as set out in this clause.
 (2) A reference in the EU IVD regulation to companion diagnostics or PMPF is disregarded.
Note: PMPF is short for post‑market performance follow‑up.
 (3) The EU IVD regulation is modified in the following ways:
 (a) the following provisions are disregarded:
 (i) point (g) of Section 1.1.6;
 (ii) the words "the authorities responsible for notified bodies, competent authorities for devices in the Member States or" in Section 1.3.2;
 (iii) the sentence "Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 52 and shall be accessible to other notified bodies." in Section 4.3;
 (iv) the subsection headed "Verification by examination and testing of every product batch" in Section 4.5.3;
 (v) the paragraph beginning "In the case of companion diagnostics," in Section 4.5.5;
 (vi) the words "under to Article 87" in Section 4.10;
 (b) in Section 1.6.1, the words "notified body coordination group referred to in Article 49 of Regulation (EU) 2017/745" are replaced with the word "Secretary";
 (c) in Section 3.2.2:
 (i) the words "Article 38(3)" are replaced with the words "Annex II of Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro medical devices under Regulation (EU 2017/746 of the European Parliament and of the Council (Commission Implementing (EU) 2017/2185)"; and
 (ii) the words "self and near patient testing" are replaced with the words "self‑testing and point of care testing";
 (d) in Section 4.5.5, the words "sufficient expertise and facilities for the procedures referred to in Section 5 of Annex IX, for which they are designated" are replaced with the words "allowing for external expert opinions to be sought when required to ensure an adequate assessment of compliance with the essential principles and these Regulations";
 (e) in Section 4.10, the words "observe the manufacturer's and competent authorities' activities and the results of the manufacturer's investigation" are replaced with the words "observe the manufacturer's activities and the results of the manufacturer's investigation, and be aware of information relating to the Secretary's vigilance and monitoring activities that is available on the TGA's website";
 (f) a reference to a class B device is taken to be a reference to a Class 2 IVD medical device;
 (g) a reference to a class C device is taken to be a reference to a Class 3 IVD medical