# The Medical Devices (Northern Ireland Protocol) Regulations 2021, Schedule 2: Fees in connection with the designation of notified bodies


Table 1
Application fees
Application
Fee
1. For initial designation submitted under Article 38
£8,252
2. For initial designation re-submitted under Article 38 where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application
£2,063
3. For reassessment under Article 44(10)
£8,252
4. For an extension of the scope of the designation under Article 46(1)
£6,504
Table 2
Fees for assessments and reviews
Activity
Fee
1. On-site assessment under Article 39(4) in connection with an application for initial designation under Article 38, or an application for reassessment under Article 44(10)
£15,904
2. On-site audit as part of an annual reassessment under Article 44(4)
£10,160
3. Observed audit of notified body personnel under Article 44(5)
£4,404
4. On-site assessment of a subsidiary
£3,876
5. ‘For-cause’ review under Article 44(7) to—
(a) review assessments by the notified body, including clinical evaluation documentation;
(b) otherwise verify compliance with the requirements of Regulation (EU) 2017/745 or address a particular issue
(a) £2,586
(b) £3,876

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Source: https://www.legislation.gov.uk/ukdsi/2021/9780348224740/schedule/2 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/schedule-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.