Regulation 19

SCHEDULE 2U.K.Fees in connection with the designation of notified bodies

Commencement Information

I1Sch. 2 in force at 27.7.2021, see reg. 1(2)

Table 1

Application fees

ApplicationFee
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]

Textual Amendments

Table 2

Fees for assessments and reviews

ActivityFee
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]

Textual Amendments