The Secretary of State in exercise of powers conferred by sections 15(1), 16(1)(a), (b), (c), (e), (g) and (i), 17(1)(b) and (c) of the Medicines and Medical Devices Act 2021(1) makes these Regulations.

The Secretary of State has carried out a public consultation in accordance with sections 45(1) of that Act.

In accordance with section 15(2) to (4) of that Act, the Secretary of State’s overarching objective in making these Regulations is safeguarding public health, 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) and (6)(a) of that Act, a draft of this instrument has been laid before and approved by a resolution of each House of Parliament.