1. For initial designation submitted under Article 38 F1of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746

F2£41,337

2. For initial designation re-submitted under Article 38 F3of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746 where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application

F4£10,335

3. For reassessment under Article 44(10) F5of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746

F6£41,337

F74. For an extension of the scope of the designation under Article 46(1) F8of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746 which extends the body’s designation to carry out tasks included in an Annex F9to Regulation (EU) 2017/745 or Regulation (EU) 2017/746 that was not previously within the body’s designation

F10£14,568

F115. For an extension of the scope of the designation under Article 46(1) F12of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746 which extends the body’s designation to carry out tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required

F13£21,105

1. On-site assessment under Article 39(4) F14of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746 in connection with an application for initial designation under Article 38 F15of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746, or an application for reassessment under Article 44(10) F16of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746

F17£67,606

2. On-site audit as part of an annual reassessment under Article 44(4) F18of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746

F19£52,929

3. Observed audit of notified body personnel under Article 44(5) F20of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746

F21£11,672

4. On-site assessment of a subsidiary

F22£26,408

5. ‘For-cause’ review under Article 44(7) F23of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746 to—

(a) review assessments by the notified body, including clinical evaluation documentation;

(b) otherwise verify compliance with the requirements of Regulation (EU) 2017/745 F24, or Regulation (EU) 2017/746 or address a particular issue

(a) F25£21,535

(b) F26£26,408