The Secretary of State makes these Regulations in exercise of the powers conferred by sections 15(1), 16(1)(a), (b), (g), (i) and (j), 17(1)(b) and (c) and 43(2) 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 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.
These Regulations may be cited as the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
These Regulations come into force 6 months after the day on which they are made.
Subject to paragraph (4), these Regulations extend to England and Wales, Scotland and Northern Ireland.
Regulation 4 extends to England and Wales and Scotland only.
Source: HMSO.