---
title: "The Medical Devices (Amendment) (Great Britain) Regulations 2025"
id: cc859d76-4509-4893-8a0c-8db889bdc4d8
authority: uk
place: "United Kingdom"
applies_also_from: []
kind: regulation
in_force: true
publisher_url: https://www.legislation.gov.uk/uksi/2025/591
attribution: "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
solon_url: https://solon.orangecat.ch/law/cc859d76-4509-4893-8a0c-8db889bdc4d8
language: en
in_force_from: 2025-05-24
date_basis: publisher
status: consolidated
source_url: https://www.legislation.gov.uk/uksi/2025/591/data.xml
read_on: 2026-11-10
sha256: 20d92a44bdc1813a6af888362e6b2c18b4476b3cd81f24c5b24679d9a6efe064
provisions: 3
---

# The Medical Devices (Amendment) (Great Britain) Regulations 2025

## Title and introductory text {#prelims}

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 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.

## 1 Citation, commencement, extent and application {#regulation-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.

## 2 Amendment to the Medical Devices Regulations 2002 {#regulation-2}

(1) The Medical Devices Regulations 2002 are amended as follows.
(2) Omit—
(a) regulation 4H (revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date),
(b) regulation 4J (revocation of Commission Regulation (EU) No 207/2012 on 26th May 2025),
(c) regulation 4K (revocation of Regulation (EU) No 722/2012 on 26th May 2025) and
(d) regulation 4L (revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date).