Regulation 19
| 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 |
| 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 |