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

PART 1Preliminary and Revocation

1Citation, commencement, extent and application

PART 2Amendment of the Medical Devices Regulations 2002

3Amendment of the Medical Devices Regulations 2002

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

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

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

7Amendment of regulation 52 (interpretation of Part VI)

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

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

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

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

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

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

14New regulation 56B

15New regulation 56C

16New regulation 56D

Part 3Amendment of the Blood Safety and Quality Regulations 2005

17Amendment of the Blood Safety and Quality Regulations 2005

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

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

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

20Amendment of regulation 16 (clinical investigation fees)

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

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

24Amendment of Schedule 1 (fees for clinical investigations)

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

Draft Regulations laid before Parliament under section 47(3) and (6)(a) of the Medicines and Medical Devices Act 2021 and paragraphs 8F(1) and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, for approval by resolution of each House of Parliament.

2023 No.

Medical Devices

Health And Safety

Fees And Charges

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

Made***

Coming into force1st April 2023

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8C of, and paragraphs 1(1)(ab) and 7(2)1 of Schedule 4 and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 20182, and sections 15(1), 16(1)(i), 17(1)(a) and 43 of the Medicines and Medical Devices Act 20213, after having considered the matters in section 15(2) to (4) of the Medicines and Medical Devices Act 2021.

The Secretary of State has carried out a public consultation in accordance with section 45(1) of the Medicines and Medical Devices Act 2021.

In accordance with section 47(3) and (6)(a) of the Medicines and Medical Devices Act 2021 and paragraphs 8F(1)4 and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of this instrument has been laid before and approved by a resolution of each House of Parliament.

The Treasury have consented to the making of these Regulations as required by paragraphs 3(1) and 10 of Schedule 4 to the European Union (Withdrawal) Act 2018.