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The Medical Devices (Northern Ireland Protocol) Regulations 2021
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- UK Statutory Instruments
- 2021 No. 905
- SCHEDULE 1
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Regulation 16
SCHEDULE 1Fees for clinical investigations
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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 |
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