The Medical Devices (Northern Ireland Protocol) Regulations 2021 No. 905

Regulation 16

SCHEDULE 1 Fees for clinical investigations

Table 1

Clinical investigation of a class I device, class IIa device or non-invasive class IIb device

Activity	Fee
1. Application submitted under Article 70(1)	£3,820
2. Application re-submitted under Article 70(1) where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application under Article 71(4)	£2,920
3. Notification of a substantial modification under Article 75(1)	£207

Table 2

Clinical investigation of an invasive class IIb device or class III device

Activity	Fee
1. Application submitted under Article 70(1)	£5,040
2. Application re-submitted under Article 70(1) where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application under Article 71(4)	£3,570
3. Notification of a substantial modification under Article 75(1)	£331