UK Statutory Instrument 2025 United Kingdom

Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025

View on legislation.gov.uk (opens in a new tab) Ask Guv about this Act

At a glance

Enforced by

MHRA

What's here

3 practical guides · 4 journeys

Step-by-step journeys using this legislation

Walkthroughs that take you from a real business situation to compliance.

Relevant guidance

Practical guides for businesses affected by this Act, ordered by how closely they engage with it.

Mentioned in related content

3 guides

What this Act requires

Sections that create concrete duties on businesses or carry penalties. Procedural and definitional sections are folded into the “Browse other sections” expander at the bottom of each group. Click any section title to read the source text on legislation.gov.uk.

Part 1 — Preliminary

Browse 1 other section in this Part — procedural / definitional / commencement
s.001

Citation, commencement, extent and application

Part 2 — Amendment of the Medical Devices Regulations 2002

Browse 11 other sections in this Part — procedural / definitional / commencement
s.002

Amendment of the Medical Devices Regulations 2002

s.003

Amendment of regulation 53 in relation to England, Scotland and Wales

s.004

Amendment of regulation 53 in relation to Northern Ireland

s.005

Amendment of regulation 54 in relation to England, Scotland and Wales

s.006

Amendment of regulation 55 in relation to England, Scotland and Wales

s.007

Amendment of regulation 55 in relation to Northern Ireland

s.008

Amendment of regulation 56 in relation to England, Scotland and Wales

s.009

Amendment of regulation 56C

s.010

Omission of regulation 56D

s.011

New regulation 56E

s.012

New regulation 58A

Part 3 — Amendment of the Blood Safety and Quality Regulations 2005

Browse 1 other section in this Part — procedural / definitional / commencement
s.013

Amendment of the Blood Safety and Quality Regulations 2005

Part 4 — Amendment of the Medical Devices (Northern Ireland Protocol) Regulations 2021

Browse 9 other sections in this Part — procedural / definitional / commencement
s.014

Amendment of the Medical Devices (Northern Ireland Protocol) Regulations 2021

s.015

Amendment of regulation 7

s.016

Amendment of regulation 16

s.017

Amendment of regulation 17A

s.018

Amendment of regulation 19

s.019

Amendment of regulation 19C

s.020

Omission of regulation 19D

s.021

Amendment of Schedule 1

s.022

Amendment of Schedule 2

Read the full Act on legislation.gov.uk (opens in a new tab)

Enforcement and responsible bodies

The regulators that administer or enforce this legislation.

MHRA

Medicines and Healthcare products Regulatory Agency

Regulates medicines, medical devices, and blood components. Ensures safety, quality, and efficacy. Issues marketing authorisations.

Explore more

Browse legislation

Find other UK business legislation with related guidance.

Regulators

Learn more about the bodies that enforce this legislation.