Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:3aa_5:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 3AA cl 5 (pt 1/2)
Character Range: 462481–465211

5  Additional modifications of EU medical devices regulations
 (1) For the purposes of subclause 2(1), the EU medical devices regulation is taken to be modified as set out in this clause.
 (2) A reference in the EU medical devices regulation to PMCF is disregarded.
Note: PMCF is short for post‑market clinical follow‑up.
 (3) The EU medical devices regulation is modified in the following ways:
 (a) the following provisions are disregarded:
 (i) the last dash point of Section 1.1.6;
 (ii) the words "the authorities responsible for notified bodies, competent authorities for medical 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 57 and shall be accessible to other notified bodies." in Section 4.3;
 (iv) the eighth dash point of Section 4.5.1;
 (v) the words "referred to in Annexes II and III" in point (b) of Section 4.5.3;
 (vi) the words "as specified in Section 15 of Annex XI" in point (d) of Section 4.5.3;
 (vii) the words "as referred to in Regulation (EU) No 722/2012," in Section 4.5.6;
 (viii) the words "for the relevant competent authority" in Section 4.5.6;
 (ix) the words "under Article 92(2)" in Section 4.10;
 (b) in Section 1.6.1, the words "notified body coordination group referred to in Article 49" are replaced with the word "Secretary";
 (c) in Section 3.2.2, the words "Article 42(3)" are replaced with the words "Annex I 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 diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Commission Implementing (EU) 2017/2185)";
 (d) in point (a) of Section 4.5.3, the words "Part B of Annex XI" are replaced with the words "Part 3 of Schedule 3 to these Regulations";
 (e) in point (b) of Section 4.5.3, the words "the EU" are replaced with the words "a relevant";
 (f) in Section 4.5.5, the words "Annex XIV" (wherever occurring) are replaced with the words "Part 8 of Schedule 3 to these Regulations";
 (g) in Section 4.5.6:
 (i) the words "sufficient expertise and facilities for the procedures referred to in Sections 5 and 6 of Annex IX, Section 6 of Annex X and Section 16 of Annex XI, 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 these Regulations"; and
 (ii)