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The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023

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Draft Legislation:

This is a draft item of legislation. This draft has since been made as a UK Statutory Instrument: The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 No. 377

  1. Introductory Text

  2. PART 1 Preliminary and Revocation

    1. 1.Citation, commencement, extent and application

    2. 2.Revocation

  3. PART 2 Amendment of the Medical Devices Regulations 2002

    1. 3.Amendment of the Medical Devices Regulations 2002

    2. 4.Amendment of regulation 2 in relation to England, Scotland and Wales (interpretation)

    3. 5.Amendment of regulation 16 in relation to England, Scotland and Wales (procedures for general medical devices for clinical investigations)

    4. 6.Amendment of regulation 29 in relation to England, Scotland and Wales (procedures for active implantable medical devices for clinical investigations)

    5. 7.Amendment of regulation 52 (interpretation of Part VI)

    6. 8.Amendment of regulation 53 in relation to England, Scotland and Wales (fees in connection with the registration of devices and changes to registration details)

    7. 9.Amendment of regulation 53 in relation to Northern Ireland (fees in connection with the registration of devices and changes to registration details)

    8. 10.Amendment of regulation 54 in relation to England, Scotland and Wales (fees payable in connection with the designation of approved bodies)

    9. 11.Amendment of regulation 55 in relation to England, Scotland and Wales (fees payable in connection with the designation etc. of conformity assessment bodies)

    10. 12.Amendment of regulation 55 in relation to Northern Ireland (fees payable in connection with the designation etc. of conformity assessment bodies)

    11. 13.Amendment of regulation 56 in relation to England, Scotland and Wales (fees payable in relation to clinical investigation notices)

    12. 14.New regulation 56B

    13. 15.New regulation 56C

    14. 16.New regulation 56D

  4. Part 3 Amendment of the Blood Safety and Quality Regulations 2005

    1. 17.Amendment of the Blood Safety and Quality Regulations 2005

  5. Part 4 Amendment of the Medical Devices (Northern Ireland Protocol) Regulations 2021

    1. 18.Amendment of the Medical Devices (Northern Ireland Protocol) Regulations 2021

    2. 19.Amendment of regulation 7 (registration of custom-made devices)

    3. 20.Amendment of regulation 16 (clinical investigation fees)

    4. 21.New regulation 17A (advice in relation to intended clinical investigations)

    5. 22.Amendment of regulation 19 (fees payable in connection with the designation of notified bodies)

    6. 23.New Part 4A

    7. 24.Amendment of Schedule 1 (fees for clinical investigations)

    8. 25.Amendment of Schedule 2 (fees in connection with the designation of notified bodies)

  6. Signature

  7. Explanatory Note

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