# The Medical Devices (Northern Ireland Protocol) Regulations 2021, Schedule 1: Fees for clinical investigations

Extent: N.I.

Table 1
Clinical investigation of a class I device, class IIa device or class IIb device, which is neither an implantable device nor a long-term invasive device
Activity
Fee
1. Application submitted under Article 70(1)
£15,309
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)
£11,701
3. Notification of a substantial modification under Article 75(1)
£226
Table 2
Clinical investigation of a class IIb device, which is either an implantable device or a long-term invasive device, or a class III device
Activity
Fee
1. Application submitted under Article 70(1)
£32,016
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)
£22,678
3. Notification of a substantial modification under Article 75(1)
£361

---
Source: https://www.legislation.gov.uk/uksi/2021/905/schedule/1 (the official version)
Page: https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/schedule-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.