Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:3aa_18:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 3AA cl 18 (pt 1/2)
Character Range: 457082–459989

18             shall                                                                   must

 (3) Subclause (2) has effect subject to subclause (6) and clauses 5 and 6.
Example: Item 4 of the table in subclause (2) does not apply to the reference to "authorised representative" in Section 4.3 of each EU regulation (see subparagraph (6)(c)(i) of this clause).
 (4) For the purposes of the EU regulations:
 (a) an activity is taken to be designated, in relation to an Australian conformity assessment body, if the activity relates to conformity assessment procedures covered by the body's conformity assessment body determination; and
 (b) a device is taken to be designated, in relation to an Australian conformity assessment body, if the device is covered by the body's conformity assessment body determination.
 (5) A reference in the EU regulations to CS is disregarded.
Note: CS is short for common specifications.

Modifications of specific provisions
 (6) Each EU regulation is taken to be modified in the following ways:
 (a) the following provisions are disregarded:
 (i) Sections 1.1.1, 1.2.6 and 1.2.8;
 (ii) the words "unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for their conformity assessment" in Section 1.4.1;
 (iii) the words "or previously applicable law within a notified body" in Section 3.2.3;
 (vi) the words "as referred to in Annexes II and III" in point (a) of Section 4.5.2;
 (vii) all the words after "resultant decision" in Section 4.8;
 (b) in Section 3.1.1:
 (i) the words "performance and safety of devices" are replaced with the words "compliance with the essential principles"; and
 (ii) the words "those set out in Annex I" are replaced with the words "the essential principles";
 (ba) in Section 3.3.1, the words "the authority responsible for notified bodies" are replaced with the words "the Secretary";
 (c) in Section 4.3:
 (i) a reference to an authorised representative is taken to be a reference to an applicant authorised by the manufacturer; and
 (ii) a reference to the corresponding Annex is taken to be a reference to the corresponding part of Schedule 3 to these Regulations; and
 (iii) the word "approval" is replaced with the word "assessment";
 (d) in Section 4.5.1, a reference to relevant Annexes is taken to be a reference to Schedule 3 to these Regulations;
 (da) in Section 4.5.2, the words "post‑market surveillance information" are replaced with the words "information from post‑marketing requirements mentioned in Schedule 3 to these Regulations";
 (e)  in Section 4.5.3, the words "For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX" are replaced with the words "For the assessment of compliance of manufacturers with clause 1.6 of Schedule 3 to these Regulations";
 (ea) in Section 4.6, the words "personnel