Part 4 Amendments to the Medical Devices (Northern Ireland Protocol) Regulations 2021

1. 27Amendment to the Medical Devices (Northern Ireland Protocol) Regulations 2021
2. 28Amendment to regulation 2 (extent and application)
3. 29Amendment to regulation 3 (interpretation)
4. 30Amendment to regulation 4 (scope)
5. 31Amendment to regulation 8 (certificates of free sale – fee)
6. 32Amendment to regulation 10 (UK(NI) indication)
7. 33New Part 2A (Making available on the market and putting into service under Regulation (EU) 2017/746)
8. 34New regulation A11 (legal representatives and contact persons for clinical investigations)
9. 35Amendment to regulation 13 (arbitration following the refusal of a clinical investigation application)
10. 36New Part 3A (Performance studies under Regulation (EU) 2017/746)
11. 37Amendment to Part 4
12. 38Amendment to regulation 18 (notified bodies)
13. 39Amendment to regulation 19 (fees payable in connection with the designation of notified bodies)
14. 40Amendment to regulation 20 (language requirements)
15. 41Amendment to regulation 23 (offence of breaching certain provisions)
16. 42Amendment to regulation 26 (enforcement)
17. 43Amendment to Schedule 2 (fees in connection with the designation of notified bodies)
18. 44Amendment to Schedule 3 (provisions breach of which is an offence under regulation 23)