Introductory text

Draft Regulations laid before Parliament under section 47(3), (4) and (6)(a) of the Medicines and Medical Devices Act 2021 (c. 3) and paragraphs 8F(1) and (2)(c) and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018 (c. 16), for approval by resolution of each House of Parliament.

MEDICAL DEVICES

FEES AND CHARGES

Made ***

Coming into force 1st April 2026

The Secretary of State makes these Regulations in exercise of the powers conferred by section 8C(1)(a) and (c) of, and paragraph 1(1)(ab)^f1 of Schedule 4 to, the European Union (Withdrawal) Act 2018^f2, and sections 15(1), 16(1)(a)(ii) and (2), 17(1)(a) and 43 of the Medicines and Medical Devices Act 2021^f3.

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 15(2) to (4) of the Medicines and Medical Devices Act 2021, the Secretary of State’s overarching objective in making these Regulations is safeguarding public health, and the Secretary of State has had regard to the matters specified in section 15(3) of that Act, and the Secretary of State considers that, where these Regulations may have an impact on the safety of medical devices, the benefits of making these Regulations outweigh the risks.

In accordance with section 47(3), (4) and (6)(a) of the Medicines and Medical Devices Act 2021 and paragraphs 8F(1) and (2)(c)^f4 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 paragraph 3(1) of Schedule 4 to the European Union (Withdrawal) Act 2018.