Statutory Instruments
2025 No. 591
MEDICAL DEVICES
The Medical Devices (Amendment) (Great Britain) Regulations 2025
Made
14th May 2025
Coming into force
24th May 2025
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.
Citation, commencement, extent and application
1.—(1) These Regulations may be cited as the Medical Devices (Amendment) (Great Britain) Regulations 2025.
(2) These Regulations come into force on 24th May 2025.
(3) These Regulations extend to England and Wales, Scotland and Northern Ireland, and apply in relation to England, Wales and Scotland only.
Amendment to the Medical Devices Regulations 2002
2.—(1) The Medical Devices Regulations 2002(2) are amended as follows.
(2) Omit—
(a)regulation 4H(3) (revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date),
(b)regulation 4J(4) (revocation of on 26th May 2025),Commission Regulation (EU) No 207/2012
(c)regulation 4K(5) (revocation of on 26th May 2025) andRegulation (EU) No 722/2012
(d)regulation 4L(6) (revocation of on 26th May 2025 and its effect before that date).Regulation (EU) No 920/2013
Merron
Parliamentary Under Secretary of State
Department of Health and Social Care
14th May 2025
2021 c. 3. Section 17 was amended by S.I. 2021/905. There are other amendments to the Act not relevant to these Regulations.
Regulation 4H was inserted by S.I. 2019/791 and amended by S.I. 2021/873.
Regulation 4J was inserted by S.I. 2019/791 and substituted by S.I. 2021/873.
Regulation 4K was inserted by S.I. 2019/791 and substituted by S.I. 2021/873.
Regulation 4L was inserted by S.I. 2019/791 and amended by S.I. 2021/873.